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Clinical Trial Results:
A Phase IIb, Randomised, Double Blind, Placebo Controlled, Parallel Group, Multicentre Dose Ranging Study of a Subcutaneous Anti-OX40L Monoclonal Antibody (KY1005) in Moderate to Severe Atopic Dermatitis (Study Testing Response Effect of KY1005 Against Moderate to Severe Atopic Dermatitis. The STREAM-AD Study)

Summary
EudraCT number	2021-000725-28
Trial protocol	ES DE BG HU PL CZ
Global end of trial date	21 Feb 2024

Results information
Results version number	v1(current)
This version publication date	30 Mar 2025
First version publication date	30 Mar 2025
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

KY1005-CT05_(DRI17366)

ISRCTN number

US NCT number

NCT05131477

WHO universal trial number (UTN)

U1111-1271-1438

Sponsor organisation name

Kymab Ltd, a Sanofi Company

Sponsor organisation address

The Eddeva Building (B920), Babraham Research Campus, Cambridge, United Kingdom, CB22 3AT

Public contact

Development Clinical Trial Desk, Kymab Ltd, a Sanofi Company, +44 1223 833301, Contact-us@sanofi.com

Scientific contact

Development Clinical Trial Desk, Kymab Ltd, a Sanofi Company, +44 1223 833301, Contact-us@sanofi.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

15 Jul 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

21 Feb 2024

Was the trial ended prematurely?

Main objective of the trial

To characterize the efficacy (including dose/exposure-response) across a range of KY1005 exposures, compared to Placebo, on the signs of Atopic Dermatitis (AD) using the Eczema Area and Severity Index (EASI) in those patients with a documented history, within 6 months prior to Baseline, of either inadequate response to topical treatments or inadvisability of topical treatments.

Protection of trial subjects

This study was conducted in accordance with the protocol and with the following: consensus ethical principles derived from international guidelines including the Declaration of Helsinki and the applicable amendments, and CIOMS International Ethical Guidelines; applicable ICH GCP guidelines; and applicable laws and regulations. Participants or their legally authorized representative (if acceptable by local regulations) were required to sign a statement of informed consent that meets the requirements of Title 21 Code of Federal Regulations Part 50, local regulations, ICH guidelines, Health Insurance Portability and Accountability Act requirements, where applicable, and the IRB/IEC or study center.

Background therapy

The permitted concomitant therapy included treatment with oral contraceptives, nasal, otological, and inhaled corticosteroids for any duration, and oral or topical antibiotics for up to 2 weeks for AD-associated superficial skin infections. Treatment with the following concomitant medications was prohibited during the study: dupilumab, topical or systemic tacrolimus and pimecrolimus, topical or systemic corticosteroids, leukotriene inhibitors, allergen immunotherapy, systemic treatment with an immunosuppressive/immunomodulating substance, treatment with a live (attenuated) immunisation (immunisation with inactivated seasonal influenza vaccine and inactivated adenovirus COVID-19 vaccines was permitted as per the protocol).

Evidence for comparator

Placebo

Actual start date of recruitment

13 Dec 2021

Long term follow-up planned

Yes

Long term follow-up rationale

Safety

Long term follow-up duration

4 Months

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 12

Country: Number of subjects enrolled

Canada: 13

Country: Number of subjects enrolled

Japan: 35

Country: Number of subjects enrolled

Taiwan: 17

Country: Number of subjects enrolled

United Kingdom: 4

Country: Number of subjects enrolled

United States: 42

Country: Number of subjects enrolled

Poland: 140

Country: Number of subjects enrolled

Spain: 10

Country: Number of subjects enrolled

Bulgaria: 60

Country: Number of subjects enrolled

Czechia: 34

Country: Number of subjects enrolled

Germany: 15

Country: Number of subjects enrolled

Hungary: 8

Worldwide total number of subjects

390

EEA total number of subjects

267

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

370

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study started in December 2021 and ended in February 2024. An individual participant was part of this study for about 1 year and 5 months. The study took place at 100 sites in 12 countries. Up to 350 participants (approximately 70 participants per treatment group) were planned to be enrolled.

Screening details

The study was performed in 2 parts: Part 1 for all population (baseline to Week 24) for efficacy and safety and Part 2 for Part 1 Responders (Week 24 to Week 52 for efficacy and Week 24 to Week 68 for safety). Responders were defined as participants who achieved ≥EASI 75 and/or IGA 0/1 at Week 24.

Period 1 title

Part 1 period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

This was a double-blind study. All participants, the investigators and their study teams, the sponsor, CRO, clinical laboratories were blinded. The IDMC was blinded or unblinded, if needed, to treatment regimen until end of the study (Week 24).

Are arms mutually exclusive

Yes

250 mg (500 mg LD) KY1005 (Part 1)

Arm description

Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

500 mg loading dose of KY1005 at baseline (administrated as an injection), followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) for 24 weeks.

250 mg (no LD) KY1005 (Part 1)

Arm description

Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg of KY1005 (administrated as an injection) at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) for 24 weeks

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered as an injection at Baseline

125 mg KY1005 (Part 1)

Arm description

Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

125 mg of KY1005 (administrated as an injection) at baseline, followed 4 weeks later with 125 mg of KY1005 every 4 weeks (Q4W) for 24 weeks

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered as an injection at Baseline

62.5 mg KY1005 (Part 1)

Arm description

Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

62.5 mg of KY1005 (administrated as an injection) at baseline, followed 4 weeks later with 62.5 mg of KY1005 every 4 weeks (Q4W) for 24 weeks

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered as an injection at Baseline

Placebo (Part 1)

Arm description

Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo was administered at Baseline as a subcutaneous injection, followed by an injection every 4 weeks (Q4W) for 24 weeks.

Number of subjects in period 1	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Started	77	78	77	79	79
Completed Week 24	68	65	69	71	60
Re-randomized at Week 24	47 ^[1]	40 ^[2]	45 ^[3]	42 ^[4]	16 ^[5]
Randomized and Treated	77	78	77	78	78
Completed	68	62	69	67	57
Not completed	9	16	8	12	22
Consent withdrawn by subject	2	9	6	2	8
Physician decision	1	-	-	-	-
Adverse event, non-fatal	3	5	1	6	4
Other	1	1	-	-	4
Randomized and Not Treated	-	-	-	1	1
Protocol deviation	2	-	-	1	-
Lack of efficacy	-	1	1	2	5

Notes
[1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants reported in this milestone are shown to clarify the participants flow according to the study design.
[2] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants reported in this milestone are shown to clarify the participants flow according to the study design.
[3] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants reported in this milestone are shown to clarify the participants flow according to the study design.
[4] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants reported in this milestone are shown to clarify the participants flow according to the study design.
[5] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
Justification: The number of participants reported in this milestone are shown to clarify the participants flow according to the study design.

Period 2 title

Part 2 Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Data analyst, Carer, Assessor

Blinding implementation details

Are arms mutually exclusive

Yes

250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (500 mg LD) at Part 1 and completed Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg KY1005 were administered every 4 weeks.

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered every 4 weeks.

250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1 and completed Part 1) were re-randomized to receive KY1005 250mg Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

250 mg KY1005 were administered every 4 weeks.

Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1 and completed Part) 1 were re-randomized to receive placebo Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered every 4 weeks.

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 125 mg at Part 1 and completed Part 1) were re-randomized to receive KY1005 125 mg Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

125 mg of KY1005 were administered every 4 weeks.

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

Arm description

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered every 4 weeks.

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (62.5 mg) were re-randomized to receive KY1005 62.5mg Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

KY1005

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

62.5 mg KY1005 were administered every 4 weeks.

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 62.5 mg at Part 1 and completed Part 1) were re-randomized to receive placebo Q4W from Week 24 to Week 52

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered every 4 weeks.

Placebo (Part 2) Continued From Part 1 Placebo

Arm description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52

Arm type

Experimental

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Matching placebo was administered every 4 weeks.

Number of subjects in period 2 ^[6]	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Started	13	34	12	28	12	33	7	35	16
Re-Randomized and Treated	13	34	11	28	12	32	7	34	15
Completed	12	31	11	24	11	28	7	29	13
Not completed	1	3	1	4	1	5	0	6	3
Consent withdrawn by subject	-	2	-	-	-	2	-	2	2
Other	-	-	-	1	1	1	-	1	-
Re-randomized and Not Treated	-	-	1	-	-	1	-	1	1
Lack of efficacy	1	1	-	3	-	1	-	2	-

Notes
[6] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: Part 2 included participants who achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (also named responders at Week 24 and "responder population"). A total of 190 participants were re-randomized 3:1 pre-dose at Week 24 to receive either same pre-Week 24 KY1005 dose/interval or placebo (KY1005 withdrawal group) during Part 2.

Baseline characteristics

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Reporting group title

250 mg (500 mg LD) KY1005 (Part 1)

Reporting group description

Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.

Reporting group title

250 mg (no LD) KY1005 (Part 1)

Reporting group description

Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.

Reporting group title

125 mg KY1005 (Part 1)

Reporting group description

Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.

Reporting group title

62.5 mg KY1005 (Part 1)

Reporting group description

Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.

Reporting group title

Placebo (Part 1)

Reporting group description

Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.

Reporting group values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)	Total
Number of subjects	77	78	77	79	79	390
Age categorical
Units: Subjects
Adults (18-64 years)	75	72	72	74	77	370
From 65-84 years	2	6	5	5	2	20
Age continuous
Units: years
arithmetic mean (standard deviation)	36.3 ( 13.32 )	40.8 ( 15.24 )	37.9 ( 15.17 )	37.6 ( 14.78 )	36.4 ( 13.07 )	-
Gender categorical
Units: Subjects
Female	30	35	39	37	30	171
Male	47	43	38	42	49	219
Race
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0
Asian	12	12	10	14	12	60
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	4	2	4	4	6	20
White	61	63	63	60	60	307
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	1	0	1	1	3
EASI Score at Baseline
Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition.
Units: units on a scale
arithmetic mean (standard deviation)	30.3 ( 11.66 )	28.7 ( 10.53 )	30.3 ( 12.43 )	28.7 ( 10.09 )	26.4 ( 7.85 )	-

End points

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Reporting group title

250 mg (500 mg LD) KY1005 (Part 1)

Reporting group description

Participants randomized to receive 500 mg loading dose of KY1005 at baseline, followed 4 weeks later with 250 mg of KY1005 every 4 weeks (Q4W) injection for 24 weeks.

Reporting group title

250 mg (no LD) KY1005 (Part 1)

Reporting group description

Participants randomized to receive 250 mg (as injection) plus placebo at baseline, followed 4 weeks later with 250 mg Q4W as injection for 24 weeks.

Reporting group title

125 mg KY1005 (Part 1)

Reporting group description

Participants randomized to receive 125 mg (as injection) plus placebo at baseline, followed 4 weeks later with 125 mg Q4W as injection for 24 weeks.

Reporting group title

62.5 mg KY1005 (Part 1)

Reporting group description

Participants randomized to receive 62.5 mg (as injection) plus placebo at baseline, followed 4 weeks later with 62.5 mg Q4W as injection for 24 weeks.

Reporting group title

Placebo (Part 1)

Reporting group description

Participants randomized to receive placebo given as injections at baseline, followed 4 weeks later with placebo (0 mg) Q4W as injection for 24 weeks.

Reporting group title

250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)

Reporting group description

Reporting group title

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

Reporting group description

Reporting group title

250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)

Reporting group description

Reporting group title

Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)

Reporting group description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) (who received 250 mg (no LD) at Part 1 and completed Part) 1 were re-randomized to receive placebo Q4W from Week 24 to Week 52

Reporting group title

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Reporting group description

Reporting group title

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

Reporting group description

Reporting group title

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)

Reporting group description

Reporting group title

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Reporting group description

Reporting group title

Placebo (Part 2) Continued From Part 1 Placebo

Reporting group description

Participants who completed Part 1 and who were responders (achieved ≥EASI 75 and/or who attained IGA 0/1 at Week 24 (Day 169) placebo received placebo Q4W from Week 24 to Week 52

Primary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

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End point title

Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

End point description

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. Full Analysis Set for Part 1. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Efficacy analyses were based on treatment allocated at randomization. The Primary efficacy endpoint is the percentage of change in EASI from Baseline to Day 113 (Week 16). The primary analysis was conducted on FAS1 after all the randomized patients have reached the Day 169 (Week 24) visit/ early termination.

End point type

Primary

End point timeframe

Baseline to Week 16

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
least squares mean (standard error)
Percentage Change in EASI from baseline to Week 16	-61.5 ( 4.68 )	-56.8 ( 4.59 )	-51.6 ( 4.59 )	-59.6 ( 4.53 )	-29.4 ( 4.76 )

Statistical analysis 1

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-32.1

Confidence interval

level

95%

sides

2-sided

lower limit

-43.9

upper limit

-20.3

Variability estimate

Standard error of the mean

Dispersion value

6.01

Statistical analysis 2

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-27.3

Confidence interval

level

95%

sides

2-sided

lower limit

-39.1

upper limit

-15.6

Variability estimate

Standard error of the mean

Dispersion value

5.98

Statistical analysis 3

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-22.2

Confidence interval

level

95%

sides

2-sided

lower limit

-34

upper limit

-10.4

Variability estimate

Standard error of the mean

Dispersion value

6.01

Statistical analysis 4

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-30.2

Confidence interval

level

95%

sides

2-sided

lower limit

-41.9

upper limit

-18.5

Variability estimate

Standard error of the mean

Dispersion value

5.95

Secondary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)

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End point title

Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)

End point description

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. The primary analysis was conducted on the FAS1 after all randomized patients have reached day 169 (Week 24) visit/ early termination. Percentage change from baseline in EASI at Day 169 (Week 24).

End point type

Secondary

End point timeframe

Baseline to Week 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
least squares mean (standard error)
Percent Change in EASI At Day 169 (Week 24)	-64.4 ( 5.17 )	-52.2 ( 5.14 )	-53.7 ( 5.08 )	-54.4 ( 5.09 )	-27.6 ( 5.29 )

Statistical analysis 1

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-36.8

Confidence interval

level

95%

sides

2-sided

lower limit

-49.8

upper limit

-23.8

Variability estimate

Standard error of the mean

Dispersion value

6.62

Statistical analysis 2

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-24.6

Confidence interval

level

95%

sides

2-sided

lower limit

-37.7

upper limit

-11.6

Variability estimate

Standard error of the mean

Dispersion value

6.67

Statistical analysis 3

Comparison groups

Placebo (Part 1) v 125 mg KY1005 (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-26.2

Confidence interval

level

95%

sides

2-sided

lower limit

-39.2

upper limit

-13.1

Variability estimate

Standard error of the mean

Dispersion value

6.65

Statistical analysis 4

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

LS mean difference

Point estimate

-26.8

Confidence interval

level

95%

sides

2-sided

lower limit

-39.7

upper limit

-13.9

Variability estimate

Standard error of the mean

Dispersion value

6.58

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)

Top of page

End point title

Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)

End point description

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. The primary analysis was conducted on the FAS1 after all randomized patients have reached day 169 (Week 24) visit/ early termination. Percentage of patients with at least 75% reduction from baseline in EASI (EASI 75) at days 113 (Week 16) and Day 169 (Week 24).

End point type

Secondary

End point timeframe

Baseline to Week 16 and Week 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 16	40.3	38.5	42.9	40.5	11.4
Week 24	54.5	38.5	49.4	40.5	17.7

Statistical analysis 1 - Week 16

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

0.42

Statistical analysis 2 - Week 16

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.27

Confidence interval

level

95%

sides

2-sided

lower limit

0.14

upper limit

0.4

Statistical analysis 3 - Week 16

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.31

Confidence interval

level

95%

sides

2-sided

lower limit

0.18

upper limit

0.44

Statistical analysis 4 - Week 16

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

0.42

Statistical analysis 1 - Week 24

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.36

Confidence interval

level

95%

sides

2-sided

lower limit

0.23

upper limit

0.5

Statistical analysis 2 - Week 24

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.004

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.07

upper limit

0.34

Statistical analysis 3 - Week 24

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Confidence interval

level

95%

Statistical analysis 4 - Week 24

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0016

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.36

Secondary: Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)

Top of page

End point title

Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)

End point description

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. The primary analysis was conducted on the FAS1 after all randomized patients have reached day 169 (Wee 24) visit/ early termination. Percentage of patients with a response of IGA 0 or 1 and a reduction from baseline of ≥ 2 points at Days 113 (Week 16) and Day 169 (Week 24).

End point type

Secondary

End point timeframe

Baseline to Week 16 and Week 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 16	22.1	14.1	19.5	25.3	5.1
Week 24	45.5	33.3	40.3	29.1	11.4

Statistical analysis 1 - Week 16

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0022

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

0.27

Statistical analysis 2 - Week 16

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0562

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.09

Confidence interval

level

95%

sides

2-sided

lower limit

upper limit

0.18

Statistical analysis 3 - Week 16

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0054

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.24

Statistical analysis 4 - Week 16

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0003

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.31

Statistical analysis 1 - Week 24

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.34

Confidence interval

level

95%

sides

2-sided

lower limit

0.21

upper limit

0.47

Statistical analysis 2 - Week 24

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.22

Confidence interval

level

95%

sides

2-sided

lower limit

0.1

upper limit

0.34

Statistical analysis 3 - Week 24

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.29

Confidence interval

level

95%

sides

2-sided

lower limit

0.16

upper limit

0.41

Statistical analysis 4 -Week 24

Comparison groups

Placebo (Part 1) v 62.5 mg KY1005 (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0046

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

0.3

Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)

Top of page

End point title

Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)

End point description

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being "no itch" and 10 being the "worst itch imaginable". The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. The primary analysis was conducted on the FAS1 after all randomized patients have reached day 169 (Week 24) visit/ early termination. Proportion of patients with improvement (reduction) of weekly average of pruritus NRS ≥ 4 a baseline pruritis NRS of ≥ 4 from baseline to Days 113 (Week 16) and Day 169 (Week 24).

End point type

Secondary

End point timeframe

Baseline to Week 16 and Week 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 16	24.7	19.2	20.8	22.8	5.1
Week 24	31.2	24.4	28.6	27.8	7.6

Statistical analysis 1 - Week 16

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0006

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.19

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.3

Statistical analysis 2 - Week 16

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0057

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.14

Confidence interval

level

95%

sides

2-sided

lower limit

0.04

upper limit

0.24

Statistical analysis 3 - Week 16

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0038

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.16

Confidence interval

level

95%

sides

2-sided

lower limit

0.05

upper limit

0.26

Statistical analysis 4 - Week 16

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0011

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.18

Confidence interval

level

95%

sides

2-sided

lower limit

0.07

upper limit

0.28

Statistical analysis 1 - Week 24

Comparison groups

250 mg (500 mg LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0002

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.23

Confidence interval

level

95%

sides

2-sided

lower limit

0.11

upper limit

0.35

Statistical analysis 2 - Week 24

Comparison groups

250 mg (no LD) KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

157

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0038

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.17

Confidence interval

level

95%

sides

2-sided

lower limit

0.06

upper limit

0.28

Statistical analysis 3 - Week 24

Comparison groups

125 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

156

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0006

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.21

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.32

Statistical analysis 4 - Week 24

Comparison groups

62.5 mg KY1005 (Part 1) v Placebo (Part 1)

Number of subjects included in analysis

158

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0008

Method

Cochran-Mantel-Haenszel

Parameter type

Proportion difference

Point estimate

0.2

Confidence interval

level

95%

sides

2-sided

lower limit

0.09

upper limit

0.32

Secondary: Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Top of page

End point title

Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on a scale
arithmetic mean (standard deviation)
Week 2 (N=73, 77, 75, 75, 78)	-8.49 ( 10.777 )	-5.27 ( 8.485 )	-6.17 ( 10.071 )	-7.51 ( 8.836 )	-3.98 ( 7.855 )
Week 4 (N= 76, 74, 76, 77, 75)	-11.21 ( 10.612 )	-8.38 ( 9.944 )	-10.33 ( 10.861 )	-10.27 ( 10.550 )	-7.20 ( 8.510 )
Week 8 (N= 70, 70, 75, 76, 72)	-15.67 ( 11.872 )	-11.93 ( 11.018 )	-13.77 ( 12.964 )	-14.37 ( 10.054 )	-7.64 ( 10.450 )
Week 12 (N= 70, 70, 72, 77, 70)	-18.49 ( 12.411 )	-13.84 ( 11.121 )	-16.56 ( 14.062 )	-16.46 ( 11.699 )	-8.76 ( 9.608 )
Week 16 (N= 70, 69, 73, 76, 69)	-19.71 ( 12.731 )	-16.31 ( 12.329 )	-15.70 ( 14.226 )	-17.82 ( 11.730 )	-7.47 ( 11.338 )
Week 20 (N= 67, 69, 72, 72, 67)	-21.93 ( 14.283 )	-16.46 ( 12.834 )	-16.98 ( 15.321 )	-16.76 ( 12.590 )	-7.91 ( 11.163 )
Week 24 (N= 71, 68, 72, 70, 67)	-21.92 ( 14.475 )	-15.72 ( 12.977 )	-16.91 ( 15.085 )	-17.09 ( 13.088 )	-7.52 ( 12.537 )

No statistical analyses for this end point

Secondary: Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Top of page

End point title

Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percent of change
arithmetic mean (standard deviation)
Week 2 (N= 73, 77, 75, 75, 78)	-27.94 ( 30.032 )	-17.75 ( 38.988 )	-19.09 ( 39.499 )	-26.03 ( 34.462 )	-15.26 ( 34.143 )
Week 4 (N= 76, 74, 76, 77, 75)	-36.85 ( 28.901 )	-29.13 ( 42.013 )	-35.10 ( 34.457 )	-35.49 ( 38.786 )	-27.56 ( 31.037 )
Week 8 (N= 70, 70, 75, 76, 72)	-50.25 ( 30.666 )	-41.21 ( 41.129 )	-45.96 ( 38.150 )	-51.70 ( 31.046 )	-28.70 ( 38.603 )
Week 12 (N= 70, 70, 72, 77, 70)	-59.61 ( 30.717 )	-50.15 ( 36.086 )	-55.23 ( 40.218 )	-57.36 ( 34.275 )	-33.72 ( 35.358 )
Week 16 (N= 70, 69, 73, 76, 69)	-62.35 ( 32.322 )	-59.98 ( 37.444 )	-52.50 ( 40.820 )	-61.51 ( 31.663 )	-28.25 ( 41.173 )
Week 20 (N= 67, 69, 72, 72, 67)	-67.85 ( 33.135 )	-57.80 ( 38.921 )	-56.29 ( 43.103 )	-57.87 ( 38.977 )	-30.32 ( 40.486 )
Week 24 (N= 71, 68, 72, 70, 67)	-68.01 ( 36.052 )	-55.84 ( 40.299 )	-56.72 ( 44.271 )	-57.37 ( 40.225 )	-28.55 ( 44.004 )

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)

Top of page

End point title

Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 2	19.5	15.4	16.9	22.8	13.9
Week 4	29.9	21.8	39.0	39.2	24.1
Week 8	45.5	38.5	53.2	54.4	27.8
Week 12	62.3	44.9	61.0	62.0	26.6
Week 16	63.6	52.6	57.1	65.8	27.8
Week 20	63.6	51.3	58.4	58.2	25.3
Week 24	66.2	43.6	55.8	53.2	24.1

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)

Top of page

End point title

Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 2	9.1	2.6	2.6	2.5	5.1
Week 4	9.1	9.0	11.7	11.4	6.3
Week 8	23.4	16.7	27.3	25.3	8.9
Week 12	33.8	25.6	44.2	43.0	11.4
Week 16	40.3	38.5	42.9	40.5	11.4
Week 20	49.4	42.3	48.1	40.5	13.9
Week 24	54.5	38.5	49.4	40.5	17.7

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)

Top of page

End point title

Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percent
number (not applicable)
Week 2	2.6	1.3	0	1.3	0
Week 4	6.5	1.3	1.3	2.5	0
Week 8	7.8	7.7	9.1	8.9	1.3
Week 12	10.4	9.0	14.3	12.7	5.1
Week 16	15.6	14.1	16.9	19.0	3.8
Week 20	27.3	23.1	24.7	19.0	7.6
Week 24	37.7	26.9	32.5	24.1	11.4

No statistical analyses for this end point

Secondary: Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)

Top of page

End point title

Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 2	0	1.3	0	0	0
Week 4	2.6	0	0	0	0
Week 8	2.6	5.1	1.3	0	0
Week 12	3.9	2.6	2.6	2.5	0
Week 16	3.9	1.3	2.6	1.3	1.3
Week 20	6.5	6.4	3.9	2.5	1.3
Week 24	7.8	6.4	9.1	1.3	3.8

No statistical analyses for this end point

Secondary: Change in IGA (Investigator Global Assessment) From Baseline to Week 24 (Part 1)

Top of page

End point title

Change in IGA (Investigator Global Assessment) From Baseline to Week 24 (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on scale
arithmetic mean (standard deviation)
Week 2 (N= 73, 77, 75, 75, 78)	-0.33 ( 0.625 )	-0.21 ( 0.408 )	-0.29 ( 0.540 )	-0.23 ( 0.481 )	-0.18 ( 0.503 )
Week 4 (N= 76, 74, 76, 77, 75)	-0.57 ( 0.869 )	-0.38 ( 0.590 )	-0.45 ( 0.620 )	-0.51 ( 0.661 )	-0.31 ( 0.592 )
Week 8 (N= 70, 70, 75, 76, 72)	-0.79 ( 0.976 )	-0.74 ( 0.829 )	-0.80 ( 0.900 )	-0.76 ( 0.709 )	-0.32 ( 0.728 )
Week 12 (N= 70, 70, 72, 77, 70)	-1.10 ( 1.024 )	-0.87 ( 0.867 )	-1.04 ( 1.013 )	-1.00 ( 0.973 )	-0.36 ( 0.660 )
Week 16 (N= 70, 69, 73, 76, 69)	-1.23 ( 0.981 )	-0.99 ( 0.899 )	-0.96 ( 1.033 )	-1.09 ( 0.969 )	-0.43 ( 0.757 )
Week 20 (N= 67, 69, 72, 72, 67)	-1.43 ( 1.118 )	-1.17 ( 1.137 )	-1.11 ( 1.120 )	-1.10 ( 0.981 )	-0.45 ( 0.822 )
Week 24 (N= 71, 68, 72, 70, 67)	-1.48 ( 1.205 )	-1.16 ( 1.241 )	-1.32 ( 1.265 )	-1.16 ( 1.030 )	-0.49 ( 0.959 )

No statistical analyses for this end point

Secondary: Change in IGA (Investigator Global Assessment) From Baseline (Part 2)

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End point title

Change in IGA (Investigator Global Assessment) From Baseline (Part 2)

End point description

The IGA is a five-point scale that provides a global clinical assessment of AD severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 31, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28 12, 33, 5, 33, 16)	-2.31 ( 0.855 )	-1.91 ( 1.026 )	-2.00 ( 0.953 )	-1.82 ( 1.156 )	-2.42 ( 0.793 )	-1.82 ( 1.131 )	-2.00 ( 1.000 )	-1.73 ( 0.911 )	-1.63 ( 1.204 )
Week 28 (N= 13, 34, 12, 28 12, 31, 7, 34, 14)	-2.46 ( 0.967 )	-2.00 ( 1.155 )	-2.17 ( 1.193 )	-1.46 ( 1.138 )	-2.25 ( 0.965 )	-1.74 ( 1.064 )	-1.71 ( 0.951 )	-1.47 ( 0.961 )	-1.71 ( 1.383 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-2.00 ( 1.000 )	-1.82 ( 1.314 )	-1.73 ( 1.348 )	-1.32 ( 1.188 )	-2.33 ( 0.985 )	-1.75 ( 1.078 )	-1.71 ( 0.951 )	-1.41 ( 1.160 )	-1.67 ( 1.234 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-2.08 ( 1.188 )	-1.70 ( 1.380 )	-1.40 ( 1.174 )	-1.29 ( 1.182 )	-2.17 ( 1.115 )	-1.81 ( 1.230 )	-2.00 ( 1.000 )	-1.53 ( 1.344 )	-1.67 ( 1.234 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-2.08 ( 1.115 )	-1.71 ( 1.395 )	-1.64 ( 1.286 )	-1.29 ( 1.301 )	-2.36 ( 1.120 )	-1.75 ( 1.164 )	-1.86 ( 1.215 )	-1.58 ( 1.311 )	-1.53 ( 1.302 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-2.00 ( 1.155 )	-1.69 ( 1.447 )	-1.73 ( 1.348 )	-1.32 ( 1.335 )	-2.08 ( 1.084 )	-1.63 ( 1.070 )	-1.71 ( 1.113 )	-1.58 ( 1.259 )	-1.64 ( 1.393 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-1.69 ( 1.182 )	-1.69 ( 1.469 )	-1.60 ( 1.350 )	-1.36 ( 1.367 )	-2.08 ( 1.084 )	-1.50 ( 1.137 )	-2.00 ( 1.414 )	-1.63 ( 1.351 )	-1.71 ( 1.590 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 31, 14)	-1.77 ( 1.301 )	-1.55 ( 1.434 )	-1.64 ( 1.286 )	-1.36 ( 1.420 )	-2.18 ( 1.401 )	-1.48 ( 1.214 )	-2.00 ( 1.155 )	-1.65 ( 1.305 )	-1.79 ( 1.672 )

No statistical analyses for this end point

Secondary: Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)

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End point title

Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)

End point description

The IGA is a five-point scale that provides a global clinical assessment of AD (Atopic Dermatitis) severity ranging from 0 to 4, where 0 indicates clear, 2 is mild, 3 is moderate, and 4 indicates severe AD. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 2	1.3	0	0	0	1.3
Week 4	5.2	1.3	1.3	2.5	2.5
Week 8	9.1	9.0	13.0	5.1	5.1
Week 12	16.9	12.8	19.5	19.0	3.8
Week 16	22.1	14.1	19.5	25.3	5.1
Week 20	33.8	25.6	27.3	21.5	8.9
Week 24	45.5	33.3	40.3	29.1	11.4

No statistical analyses for this end point

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

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End point title

Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

End point description

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N= 76, 74, 76, 77, 75)	-15.30 ( 16.517 )	-12.27 ( 13.455 )	-15.89 ( 14.865 )	-14.43 ( 13.691 )	-11.13 ( 14.243 )
Week 8 (N= 70, 70, 75, 76, 72)	-22.39 ( 19.368 )	-19.61 ( 17.527 )	-21.49 ( 19.200 )	-21.42 ( 16.956 )	-12.50 ( 16.584 )
Week 12 (N= 70, 70, 72, 77, 70)	-27.80 ( 19.621 )	-22.31 ( 17.936 )	-27.72 ( 20.084 )	-26.45 ( 19.649 )	-13.97 ( 16.898 )
Week 16 (N= 70, 69, 73, 76, 68)	-30.12 ( 20.086 )	-25.07 ( 20.233 )	-26.28 ( 21.258 )	-28.15 ( 19.831 )	-13.85 ( 18.123 )
Week 20 (N= 67, 69, 72, 72, 67)	-34.89 ( 22.369 )	-28.04 ( 22.472 )	-29.80 ( 23.594 )	-26.71 ( 21.056 )	-13.91 ( 19.325 )
Week 24 (N= 71, 68, 70, 70, 67)	-36.19 ( 24.605 )	-27.28 ( 22.937 )	-29.96 ( 25.735 )	-28.48 ( 21.793 )	-15.08 ( 22.739 )

No statistical analyses for this end point

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

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End point title

Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

End point description

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28, 12, 31, 5, 33, 16)	-52.22 ( 14.314 )	-44.25 ( 21.879 )	-42.44 ( 21.879 )	-36.77 ( 21.919 )	-49.87 ( 13.012 )	-41.65 ( 24.173 )	-45.20 ( 18.017 )	-38.45 ( 22.077 )	-40.54 ( 23.584 )
Week 28 (N= 13, 34, 12, 28, 12, 31, 7, 34, 13)	-54.19 ( 18.525 )	-44.30 ( 23.737 )	-43.38 ( 24.261 )	-33.40 ( 23.845 )	-47.15 ( 16.401 )	-43.95 ( 24.475 )	-41.17 ( 19.190 )	-37.46 ( 23.843 )	-42.98 ( 24.770 )
Week 32 (N= 13, 34, 11, 28, 12, 32, 7, 32, 15)	-51.19 ( 23.086 )	-41.55 ( 25.962 )	-37.58 ( 27.000 )	-28.31 ( 23.318 )	-50.76 ( 16.285 )	-44.04 ( 22.541 )	-40.76 ( 17.685 )	-36.72 ( 25.421 )	-37.81 ( 25.964 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-49.68 ( 25.709 )	-38.72 ( 27.164 )	-33.91 ( 26.686 )	-27.91 ( 24.154 )	-52.12 ( 19.167 )	-45.28 ( 23.438 )	-40.09 ( 16.767 )	-37.15 ( 27.483 )	-39.35 ( 25.340 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-49.88 ( 26.342 )	-38.96 ( 29.090 )	-36.05 ( 27.550 )	-30.05 ( 26.602 )	-52.42 ( 19.560 )	-42.93 ( 24.694 )	-45.31 ( 22.710 )	-37.75 ( 27.127 )	-36.74 ( 25.865 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-47.38 ( 26.194 )	-38.61 ( 28.602 )	-37.95 ( 28.362 )	-29.98 ( 26.387 )	-51.14 ( 20.299 )	-40.96 ( 24.470 )	-36.39 ( 21.651 )	-36.83 ( 27.061 )	-37.47 ( 27.887 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-39.75 ( 25.447 )	-38.18 ( 29.948 )	-35.13 ( 27.409 )	-29.71 ( 28.021 )	-52.40 ( 22.250 )	-38.38 ( 24.940 )	-43.80 ( 27.380 )	-37.64 ( 28.543 )	-38.10 ( 28.181 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 30, 14)	-40.26 ( 26.751 )	-34.69 ( 28.925 )	-35.04 ( 27.120 )	-29.26 ( 27.488 )	-50.26 ( 26.772 )	-37.07 ( 25.763 )	-42.26 ( 25.861 )	-38.41 ( 26.915 )	-39.94 ( 29.182 )

No statistical analyses for this end point

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

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End point title

Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
arithmetic mean (standard deviation)
Week 4 (N= 76, 74, 76, 77, 75)	-22.02 ( 22.050 )	-18.52 ( 20.315 )	-22.76 ( 20.903 )	-21.42 ( 21.101 )	-16.67 ( 21.045 )
Week 8 (N= 70, 70, 75, 76, 72)	-31.84 ( 24.549 )	-30.00 ( 28.050 )	-30.47 ( 26.260 )	-32.07 ( 23.600 )	-18.27 ( 23.875 )
Week 12 (N= 70, 70, 72, 77, 70)	-40.32 ( 25.145 )	-33.64 ( 26.502 )	-39.38 ( 27.228 )	-39.22 ( 26.807 )	-20.70 ( 24.587 )
Week 16 (N= 70, 69, 73, 76, 68)	-43.25 ( 26.555 )	-37.18 ( 28.395 )	-37.33 ( 29.071 )	-41.44 ( 26.134 )	-20.87 ( 26.791 )
Week 20 (N= 67, 69, 72, 72, 67)	-49.92 ( 28.279 )	-42.07 ( 32.179 )	-42.30 ( 32.422 )	-39.05 ( 28.347 )	-20.88 ( 28.527 )
Week 24 (N= 71, 68, 70, 70, 67)	-57.87 ( 32.609 )	-41.04 ( 34.212 )	-42.58 ( 35.812 )	-41.49 ( 29.263 )	-22.21 ( 33.233 )

No statistical analyses for this end point

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

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End point title

Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

End point description

SCORAD was used to assess the extent and severity of AD (Atopic Dermatitis). Extent and severity of eczema as well as subjective assessment of symptoms were assessed and scored. SCORAD total score ranges from 0 (absent disease) to 103 (severe disease). The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28, 12, 31, 5, 33, 16)	-76.47 ( 11.581 )	-63.86 ( 27.005 )	-60.09 ( 26.373 )	-57.73 ( 34.302 )	-72.55 ( 15.422 )	-58.96 ( 31.260 )	-66.12 ( 19.532 )	-55.75 ( 26.945 )	-60.13 ( 33.848 )
Week 28 (N= 13, 34, 12, 28 12, 31, 7, 34, 13)	-78.39 ( 16.236 )	-63.35 ( 28.625 )	-62.58 ( 32.229 )	-52.12 ( 35.950 )	-68.39 ( 21.143 )	-61.69 ( 32.214 )	-64.22 ( 18.649 )	-53.98 ( 29.707 )	-62.81 ( 36.300 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-72.44 ( 25.786 )	-59.37 ( 33.889 )	-53.42 ( 34.955 )	-44.49 ( 35.890 )	-74.03 ( 21.589 )	-62.38 ( 31.104 )	-64.07 ( 16.853 )	-52.47 ( 31.788 )	-56.11 ( 38.003 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-71.50 ( 31.364 )	-55.13 ( 35.598 )	-49.88 ( 36.111 )	-43.78 ( 36.278 )	-75.08 ( 21.563 )	-63.79 ( 31.710 )	-64.24 ( 20.730 )	-53.95 ( 35.053 )	-58.72 ( 36.827 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-71.43 ( 31.643 )	-54.79 ( 38.533 )	-51.85 ( 37.053 )	-46.81 ( 39.055 )	-74.34 ( 22.474 )	-61.12 ( 34.217 )	-70.27 ( 20.037 )	-54.56 ( 34.785 )	-54.24 ( 36.614 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-67.26 ( 31.749 )	-54.96 ( 38.272 )	-54.10 ( 37.251 )	-46.95 ( 39.736 )	-73.34 ( 22.409 )	-57.94 ( 33.953 )	-58.19 ( 33.365 )	-52.89 ( 34.032 )	-55.26 ( 39.204 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-59.99 ( 35.979 )	-53.71 ( 39.548 )	-51.66 ( 37.347 )	-45.48 ( 41.426 )	-74.37 ( 23.066 )	-54.55 ( 34.719 )	-67.92 ( 35.766 )	-54.29 ( 35.851 )	-56.30 ( 39.696 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 30, 14)	-60.41 ( 36.686 )	-49.90 ( 40.104 )	-49.68 ( 35.129 )	-44.93 ( 40.527 )	-69.62 ( 29.104 )	-52.47 ( 35.396 )	-65.97 ( 34.709 )	-56.19 ( 34.460 )	-58.86 ( 40.701 )

No statistical analyses for this end point

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

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End point title

Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

End point description

The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of body surface
arithmetic mean (standard deviation)
Week 2 (N= 32, 36, 36, 39, 38)	-4.50 ( 10.610 )	-5.61 ( 10.165 )	-9.08 ( 15.999 )	-7.41 ( 12.588 )	-4.84 ( 9.113 )
Week 4 (N= 76, 74, 76, 77, 75)	-12.83 ( 15.922 )	-10.16 ( 12.917 )	-13.34 ( 17.347 )	-12.51 ( 16.318 )	-9.67 ( 16.941 )
Week 8 (N= 70, 70, 75, 76, 72)	-19.37 ( 18.857 )	-15.77 ( 17.004 )	-17.55 ( 21.064 )	-19.11 ( 18.253 )	-10.00 ( 17.375 )
Week 12 (N= 70, 70, 72, 77, 70)	-24.13 ( 18.097 )	-19.54 ( 19.578 )	-21.94 ( 22.715 )	-24.14 ( 19.903 )	-11.46 ( 17.035 )
Week 16 (N= 70, 69, 73, 76, 68)	-26.91 ( 20.286 )	-22.71 ( 21.966 )	-21.74 ( 24.799 )	-26.04 ( 20.403 )	-8.87 ( 16.956 )
Week 20 (N= 67, 69, 72, 72, 67)	-30.25 ( 21.850 )	-23.33 ( 22.600 )	-24.35 ( 26.238 )	-24.63 ( 21.263 )	-11.04 ( 19.653 )
Week 24 (N= 71, 68, 70, 70, 67)	-31.35 ( 22.434 )	-21.82 ( 21.882 )	-22.66 ( 27.317 )	-25.77 ( 22.085 )	-10.45 ( 20.837 )

No statistical analyses for this end point

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

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End point title

Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

End point description

The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of body surface
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28 12, 31, 5, 33, 16)	-46.92 ( 22.009 )	-37.94 ( 18.723 )	-37.17 ( 17.994 )	-28.14 ( 21.790 )	-41.17 ( 22.982 )	-33.81 ( 26.454 )	-40.60 ( 26.006 )	-34.30 ( 19.787 )	-32.06 ( 22.831 )
Week 28 (N= 13, 34, 12, 28 12, 31, 7, 34, 13)	-48.69 ( 23.329 )	-38.68 ( 20.582 )	-35.92 ( 20.804 )	-25.54 ( 22.718 )	-40.00 ( 23.394 )	-35.61 ( 25.720 )	-37.14 ( 23.801 )	-33.62 ( 19.692 )	-36.00 ( 24.553 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-47.15 ( 25.271 )	-36.62 ( 23.049 )	-29.64 ( 25.590 )	-23.21 ( 23.710 )	-42.08 ( 22.685 )	-35.94 ( 26.193 )	-38.00 ( 23.847 )	-32.13 ( 21.515 )	-30.07 ( 22.861 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-46.00 ( 26.242 )	-33.61 ( 24.187 )	-28.30 ( 26.437 )	-22.21 ( 23.857 )	-41.67 ( 23.051 )	-35.75 ( 25.664 )	-37.86 ( 24.674 )	-30.91 ( 24.288 )	-31.27 ( 24.391 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-46.62 ( 26.314 )	-32.94 ( 24.589 )	-29.18 ( 24.774 )	-22.57 ( 23.841 )	-41.45 ( 23.729 )	-33.41 ( 22.649 )	-39.57 ( 24.758 )	-32.00 ( 23.697 )	-31.27 ( 24.566 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-47.23 ( 26.540 )	-33.22 ( 24.143 )	-29.73 ( 25.503 )	-22.21 ( 23.706 )	-42.17 ( 25.283 )	-31.91 ( 22.069 )	-34.43 ( 25.172 )	-32.23 ( 23.250 )	-27.43 ( 20.478 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-35.69 ( 26.183 )	-32.72 ( 25.358 )	-28.30 ( 26.378 )	-22.50 ( 24.053 )	-42.92 ( 25.336 )	-30.53 ( 23.544 )	-36.43 ( 21.141 )	-31.13 ( 26.208 )	-26.93 ( 20.775 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 30, 14)	-35.54 ( 26.384 )	-29.48 ( 22.232 )	-29.55 ( 25.359 )	-22.46 ( 23.562 )	-45.09 ( 25.770 )	-29.66 ( 23.818 )	-34.71 ( 18.688 )	-33.33 ( 22.702 )	-27.21 ( 20.955 )

No statistical analyses for this end point

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

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End point title

Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

End point description

The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
arithmetic mean (standard deviation)
Week 2 (N= 32, 36, 36, 39, 38)	-10.11 ( 24.013 )	-12.23 ( 26.053 )	-19.43 ( 30.139 )	-15.06 ( 37.312 )	-11.45 ( 22.767 )
Week 4 (N= 76, 74, 76, 77, 75)	-26.45 ( 28.733 )	-23.44 ( 28.941 )	-29.46 ( 32.934 )	-28.84 ( 38.412 )	-20.92 ( 38.260 )
Week 8 (N= 70, 70, 75, 76, 72)	-39.12 ( 31.915 )	-36.01 ( 35.268 )	-37.60 ( 36.988 )	-42.84 ( 33.931 )	-21.24 ( 40.914 )
Week 12 (N= 70, 70, 72, 77, 70)	-49.88 ( 29.737 )	-43.68 ( 38.140 )	-47.04 ( 40.519 )	-52.16 ( 35.736 )	-26.56 ( 36.705 )
Week 16 (N= 70, 69, 73, 76, 68)	-54.58 ( 32.206 )	-49.44 ( 40.861 )	-46.35 ( 43.511 )	-56.36 ( 35.593 )	-22.37 ( 40.483 )
Week 20 (N= 67, 69, 72, 72, 67)	-59.75 ( 33.804 )	-51.07 ( 42.023 )	-50.36 ( 45.871 )	-53.55 ( 42.762 )	-25.46 ( 42.034 )
Week 24 (N= 71, 68, 70, 70, 67)	-63.02 ( 36.184 )	-49.42 ( 43.012 )	-48.11 ( 48.748 )	-52.94 ( 44.872 )	-23.76 ( 44.394 )

No statistical analyses for this end point

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

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End point title

Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

End point description

The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28 12, 31, 5, 33, 16)	-88.09 ( 12.983 )	-78.75 ( 27.966 )	-80.67 ( 27.843 )	-67.85 ( 39.902 )	-85.29 ( 19.008 )	-71.05 ( 39.900 )	-80.52 ( 14.717 )	-74.02 ( 31.419 )	-72.91 ( 34.317 )
Week 28 (N= 13, 34, 12, 28 12, 31, 7, 34, 13)	-90.51 ( 10.816 )	-79.51 ( 29.501 )	-76.55 ( 35.680 )	-62.09 ( 42.748 )	-81.75 ( 24.996 )	-73.28 ( 40.454 )	-88.57 ( 5.800 )	-72.98 ( 30.947 )	-75.14 ( 37.955 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-83.58 ( 23.940 )	-75.09 ( 36.907 )	-65.07 ( 49.743 )	-55.89 ( 45.768 )	-86.34 ( 18.724 )	-74.61 ( 40.429 )	-90.31 ( 10.263 )	-66.90 ( 35.357 )	-69.74 ( 38.644 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-81.56 ( 27.924 )	-68.81 ( 40.261 )	-61.93 ( 51.222 )	-53.48 ( 45.933 )	-85.33 ( 18.348 )	-74.73 ( 40.570 )	-89.70 ( 10.552 )	-63.85 ( 46.152 )	-72.34 ( 39.621 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-82.62 ( 28.019 )	-66.33 ( 41.876 )	-64.54 ( 49.422 )	-54.92 ( 47.035 )	-86.81 ( 17.237 )	-72.10 ( 41.016 )	-94.09 ( 5.083 )	-66.00 ( 43.207 )	-72.08 ( 39.691 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-83.52 ( 28.118 )	-66.91 ( 41.122 )	-65.54 ( 49.945 )	-53.82 ( 46.414 )	-84.47 ( 24.104 )	-69.38 ( 41.133 )	-81.11 ( 19.107 )	-66.54 ( 41.241 )	-70.30 ( 40.560 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-69.37 ( 40.195 )	-64.74 ( 42.092 )	-62.01 ( 51.359 )	-52.52 ( 47.479 )	-85.70 ( 19.040 )	-64.73 ( 42.700 )	-87.79 ( 16.209 )	-62.58 ( 48.827 )	-68.01 ( 40.428 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 30, 14)	-68.90 ( 40.301 )	-61.59 ( 42.339 )	-64.90 ( 49.605 )	-52.82 ( 47.733 )	-89.06 ( 14.176 )	-62.25 ( 42.451 )	-85.46 ( 16.921 )	-68.75 ( 39.935 )	-68.78 ( 41.236 )

No statistical analyses for this end point

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

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End point title

Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

End point description

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on a scale
arithmetic mean (standard deviation)
Week 4 (N= 75, 74, 76, 77, 75)	-4.40 ( 6.403 )	-4.01 ( 6.287 )	-5.42 ( 6.498 )	-4.08 ( 5.448 )	-2.32 ( 5.910 )
Week 8 (N= 70, 70, 74, 76, 72)	-7.03 ( 6.869 )	-5.13 ( 7.093 )	-5.70 ( 6.943 )	-6.75 ( 6.646 )	-2.13 ( 6.400 )
Week 12 (N= 69, 70, 72, 77, 70)	-7.87 ( 7.286 )	-6.50 ( 7.229 )	-7.29 ( 7.216 )	-7.36 ( 7.460 )	-2.26 ( 6.088 )
Week 16 (N= 69, 69, 73, 76, 68)	-8.28 ( 7.286 )	-7.23 ( 7.744 )	-7.19 ( 7.720 )	-7.32 ( 7.017 )	-2.37 ( 6.867 )
Week 20 (N= 66, 69, 72, 72, 67)	-9.39 ( 7.577 )	-7.13 ( 8.662 )	-8.10 ( 8.150 )	-7.39 ( 7.721 )	-2.33 ( 6.821 )
Week 24 (N= 70, 68, 70, 70, 67)	-9.96 ( 7.888 )	-7.21 ( 8.213 )	-7.86 ( 8.572 )	-7.64 ( 7.011 )	-2.19 ( 7.310 )

No statistical analyses for this end point

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

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End point title

Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

End point description

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 33, 12, 28, 12, 31, 5, 33, 16)	-15.31 ( 6.061 )	-11.97 ( 6.410 )	-11.58 ( 8.586 )	-9.25 ( 8.347 )	-11.75 ( 7.086 )	-10.42 ( 7.580 )	-14.00 ( 6.205 )	-9.45 ( 7.155 )	-8.75 ( 7.197 )
Week 32 (N= 13, 30, 11, 28, 12, 31, 7, 31, 13)	-14.69 ( 8.499 )	-10.23 ( 8.320 )	-11.91 ( 8.240 )	-6.79 ( 8.875 )	-12.83 ( 7.082 )	-11.32 ( 8.113 )	-11.29 ( 10.323 )	-9.42 ( 7.784 )	-7.62 ( 8.856 )
Week 36 (N= 13, 32, 10, 28, 12, 32, 7, 32, 14)	-13.23 ( 8.738 )	-9.91 ( 8.129 )	-11.90 ( 7.264 )	-7.00 ( 8.932 )	-13.00 ( 7.019 )	-11.75 ( 8.370 )	-12.57 ( 9.502 )	-8.66 ( 7.790 )	-7.93 ( 7.966 )
Week 40 (N= 13, 30, 11, 28, 11, 32, 7, 31, 14)	-13.92 ( 8.411 )	-9.10 ( 8.715 )	-11.00 ( 6.633 )	-7.82 ( 9.302 )	-11.73 ( 8.162 )	-11.88 ( 8.698 )	-11.29 ( 8.995 )	-8.81 ( 8.300 )	-7.50 ( 7.714 )
Week 44 (N= 13, 31, 11, 28, 12, 32, 7, 31, 14)	-13.31 ( 8.460 )	-9.81 ( 8.920 )	-10.45 ( 6.699 )	-6.50 ( 8.804 )	-11.92 ( 8.262 )	-10.19 ( 8.31 )	-7.86 ( 7.515 )	-8.71 ( 8.158 )	-7.93 ( 7.908 )
Week 48 (N= 13, 31, 10, 28, 12, 30, 7, 30, 14)	-11.69 ( 9.861 )	-10.39 ( 8.519 )	-11.50 ( 6.916 )	-7.50 ( 9.836 )	-11.75 ( 9.836 )	-10.33 ( 8.125 )	-9.57 ( 9.126 )	-9.90 ( 8.660 )	-7.50 ( 8.438 )
Week 52 (N= 13, 30, 11, 28, 11, 29, 7, 31, 14)	-11.85 ( 10.148 )	-9.13 ( 8.320 )	-11.36 ( 6.889 )	-6.82 ( 9.318 )	-10.64 ( 10.053 )	-8.55 ( 8.240 )	-10.00 ( 9.452 )	-8.58 ( 9.164 )	-8.50 ( 9.146 )

No statistical analyses for this end point

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

Top of page

End point title

Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 4, 8, 12, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
arithmetic mean (standard deviation)
Week 4 (N= 75, 73, 76, 77, 75)	-20.81 ( 34.179 )	-21.02 ( 31.360 )	-22.77 ( 30.783 )	-17.94 ( 30.152 )	-8.99 ( 39.554 )
Week 8 (N= 70, 69, 74, 76, 72)	-33.06 ( 41.272 )	-26.52 ( 33.397 )	-26.62 ( 34.946 )	-34.60 ( 31.584 )	-6.28 ( 42.851 )
Week 12 (N= 69, 69, 72, 77, 70)	-36.22 ( 43.169 )	-32.42 ( 32.145 )	-33.33 ( 33.732 )	-34.61 ( 34.275 )	-8.04 ( 41.445 )
Week 16 (N= 69, 68, 73, 76, 68)	-37.08 ( 52.391 )	-34.71 ( 34.574 )	-32.78 ( 36.449 )	-35.49 ( 32.862 )	-8.12 ( 45.515 )
Week 20 (N= 66, 68, 72, 72, 67)	-44.03 ( 38.850 )	-34.23 ( 38.938 )	-37.38 ( 38.448 )	-35.37 ( 36.589 )	-8.32 ( 44.942 )
Week 24 (N= 70, 67, 70, 70, 67)	-44.69 ( 61.808 )	-33.91 ( 48.273 )	-36.65 ( 40.947 )	-36.81 ( 34.444 )	-6.98 ( 49.837 )

No statistical analyses for this end point

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

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End point title

Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

End point description

POEM is a 7-item (dryness, itching, flaking, cracking, sleep loss, bleeding, and weeping) questionnaire to assess frequency of disease symptoms with a scoring system of 0 to 28. The higher score indicating higher severity. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 32, 36, 40. 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 33, 12, 28, 12, 31, 5, 33, 16)	-72.61 ( 19.898 )	-61.00 ( 30.657 )	-54.05 ( 38.147 )	-46.08 ( 37.356 )	-60.03 ( 30.545 )	-51.61 ( 35.438 )	-64.00 ( 20.049 )	-45.63 ( 34.579 )	-47.92 ( 40.572 )
Week 32 (N= 13, 30, 11, 28, 12, 31, 7, 31, 13)	-64.90 ( 38.029 )	-50.03 ( 44.543 )	-56.00 ( 35.875 )	-30.61 ( 39.689 )	-64.21 ( 28.981 )	-55.82 ( 36.229 )	-47.30 ( 57.463 )	-46.42 ( 38.011 )	-43.95 ( 50.962 )
Week 36 (N= 13, 32, 10, 28, 12, 32, 7, 32, 14)	-60.09 ( 40.508 )	-48.61 ( 43.883 )	-57.09 ( 34.068 )	-33.73 ( 38.724 )	-66.78 ( 27.084 )	-57.38 ( 37.436 )	-57.54 ( 59.987 )	-43.35 ( 40.000 )	-44.58 ( 45.387 )
Week 40 (N= 13, 30, 11, 28, 11, 32, 7, 31, 14)	-62.85 ( 38.659 )	-44.35 ( 45.524 )	-54.47 ( 35.815 )	-37.89 ( 40.032 )	-58.98 ( 33.289 )	-58.12 ( 38.754 )	-49.79 ( 55.862 )	-43.75 ( 40.933 )	-42.88 ( 45.567 )
Week 44 (N= 13, 31, 11, 28, 12, 32, 7, 31, 14)	-60.83 ( 40.648 )	-48.48 ( 47.524 )	-52.24 ( 36.218 )	-30.25 ( 43.110 )	-59.17 ( 35.572 )	-50.10 ( 37.814 )	-36.09 ( 53.637 )	-43.16 ( 39.688 )	-46.19 ( 46.429 )
Week 48 (N= 13, 31, 10, 28, 12, 30, 7, 30, 14)	-54.56 ( 46.380 )	-51.53 ( 44.857 )	-55.93 ( 35.043 )	-35.37 ( 42.309 )	-58.18 ( 46.077 )	-51.56 ( 39.299 )	-44.04 ( 58.904 )	-50.45 ( 41.809 )	-43.48 ( 48.292 )
Week 52 (N= 13, 30, 11, 28, 11, 29, 7, 31, 14)	-54.68 ( 45.987 )	-44.51 ( 43.725 )	-54.47 ( 34.319 )	-29.38 ( 46.373 )	-52.64 ( 47.556 )	-43.45 ( 42.459 )	-48.82 ( 63.478 )	-43.01 ( 45.577 )	-47.62 ( 50.785 )

No statistical analyses for this end point

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

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End point title

Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

End point description

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline at Weeks 2, 8, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on the scale
arithmetic mean (standard deviation)
Week 2 (N= 71, 77, 75, 75, 78)	-3.63 ( 4.992 )	-2.82 ( 4.850 )	-3.32 ( 5.745 )	-3.40 ( 5.131 )	-2.09 ( 4.710 )
Week 8 (N= 70, 69, 74, 76, 72)	-6.13 ( 6.164 )	-5.59 ( 5.553 )	-5.08 ( 7.252 )	-7.13 ( 5.954 )	-2.43 ( 5.466 )
Week 16 (N= 67, 67, 73, 76, 68)	-7.79 ( 6.832 )	-6.25 ( 6.246 )	-6.47 ( 7.835 )	-7.76 ( 6.265 )	-2.35 ( 6.069 )
Week 20 (N= 66, 69, 72, 72, 67)	-7.89 ( 6.848 )	-6.42 ( 6.833 )	-6.97 ( 8.512 )	-7.31 ( 7.132 )	-2.39 ( 6.391 )
Week 24 (N= 70, 68, 70, 70, 67)	-8.33 ( 7.036 )	-6.54 ( 6.384 )	-6.74 ( 8.681 )	-7.69 ( 7.230 )	-2.30 ( 6.406 )

No statistical analyses for this end point

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

Top of page

End point title

Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

End point description

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 33, 12, 28, 12, 31, 5, 33, 16)	-12.54 ( 6.703 )	-9.00 ( 6.290 )	-9.08 ( 6.487 )	-7.57 ( 7.295 )	-11.42 ( 7.115 )	-8.26 ( 9.338 )	-15.40 ( 8.562 )	-9.67 ( 7.712 )	-6.44 ( 7.420 )
Week 28 (N= 13, 33, 12, 28, 12, 31, 7, 34, 13)	-12.62 ( 8.191 )	-9.52 ( 6.929 )	-9.83 ( 6.658 )	-7.21 ( 6.488 )	-11.33 ( 7.832 )	-8.45 ( 9.705 )	-12.29 ( 9.232 )	-9.68 ( 8.029 )	-5.77 ( 8.633 )
Week 32 (N= 13, 33, 11, 28, 12, 32, 7, 32, 15)	-12.38 ( 8.272 )	-8.00 ( 7.612 )	-8.55 ( 8.238 )	-5.75 ( 7.183 )	-12.25 ( 7.700 )	-8.50 ( 9.629 )	-13.14 ( 8.050 )	-9.13 ( 7.906 )	-5.47 ( 7.963 )
Week 36 (N= 13, 32, 10, 28, 12, 32, 7, 32, 14)	-11.85 ( 8.122 )	-7.72 ( 7.985 )	-7.90 ( 6.903 )	-6.18 ( 7.222 )	-12.58 ( 7.716 )	-8.84 ( 9.893 )	-14.00 ( 8.446 )	-8.53 ( 7.927 )	-5.93 ( 7.839 )
Week 40 (N= 13, 30, 11, 28, 11, 32, 7, 31, 14)	-12.23 ( 7.715 )	-7.07 ( 8.073 )	-7.18 ( 5.456 )	-6.21 ( 7.279 )	-11.27 ( 7.976 )	-8.06 ( 9.844 )	-14.57 ( 7.569 )	-8.23 ( 8.281 )	-5.36 ( 8.308 )
Week 44 (N= 13, 31, 11, 28, 12, 32, 7, 31, 14)	-11.38 ( 8.109 )	-7.19 ( 7.943 )	-8.18 ( 6.258 )	-5.68 ( 7.029 )	-12.08 ( 8.426 )	-6.88 ( 9.587 )	-10.29 ( 7.889 )	-8.26 ( 8.058 )	-5.93 ( 6.889 )
Week 48 (N= 13, 31, 10, 28, 12, 30, 7, 30, 14)	-9.92 ( 6.800 )	-7.29 ( 8.022 )	-8.40 ( 7.516 )	-6.21 ( 7.218 )	-11.92 ( 8.229 )	-6.83 ( 9.322 )	-11.29 ( 6.237 )	-7.93 ( 7.891 )	-6.79 ( 7.040 )
Week 52 (N= 13, 30, 11, 28, 11, 29, 7, 31, 14)	-9.08 ( 6.652 )	-6.83 ( 7.852 )	-8.09 ( 7.077 )	-5.93 ( 7.383 )	-12.55 ( 9.136 )	-6.41 ( 9.428 )	-11.57 ( 6.705 )	-8.10 ( 7.752 )	-6.64 ( 6.902 )

No statistical analyses for this end point

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

Top of page

End point title

Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 2, 8, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
arithmetic mean (standard deviation)
Week 2 (N= 71, 77, 75, 74, 78)	-22.68 ( 31.305 )	-11.95 ( 47.921 )	-16.80 ( 41.680 )	-22.73 ( 32.711 )	-10.30 ( 37.999 )
Week 8 (N= 70, 69, 74, 75, 72)	-36.87 ( 36.954 )	-36.14 ( 41.176 )	-27.54 ( 59.199 )	-45.85 ( 32.198 )	-13.12 ( 42.775 )
Week 16 (N= 67, 67, 73, 75, 68)	-46.69 ( 40.563 )	-41.27 ( 43.616 )	-34.02 ( 62.565 )	-48.96 ( 29.801 )	-11.35 ( 51.739 )
Week 20 (N= 66, 69, 72, 72, 67)	-47.48 ( 40.616 )	-42.90 ( 46.336 )	-35.79 ( 67.398 )	-44.33 ( 36.816 )	-12.08 ( 49.973 )
Week 24 (N= 70, 68, 70, 70, 67)	-51.84 ( 41.442 )	-42.36 ( 45.550 )	-33.28 ( 72.816 )	-45.63 ( 33.860 )	-11.91 ( 55.694 )

No statistical analyses for this end point

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

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End point title

Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

End point description

DLQI is a questionnaire with a score system of 0 to 30 the high score is indicative of poor QoL. The Full Analysis Set (FAS2) for Part 2 included all re-randomized Participants at week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 33, 12, 28, 12, 31, 5, 33, 16)	-75.53 ( 26.705 )	-61.64 ( 35.809 )	-64.74 ( 31.091 )	-44.26 ( 57.217 )	-72.47 ( 27.818 )	-47.08 ( 82.439 )	-70.77 ( 27.653 )	-55.36 ( 33.443 )	-48.30 ( 57.726 )
Week 28 (N= 13, 33, 12, 28, 12, 31, 7, 34, 13)	-72.50 ( 37.184 )	-62.65 ( 43.216 )	-71.77 ( 29.970 )	-44.81 ( 56.575 )	-70.02 ( 28.760 )	-48.86 ( 83.936 )	-65.28 ( 26.807 )	-55.62 ( 34.382 )	-41.13 ( 80.192 )
Week 32 (N= 13, 33, 11, 28, 12, 32, 7, 32, 15)	-68.19 ( 38.039 )	-48.69 ( 56.833 )	-61.68 ( 42.315 )	-31.65 ( 55.087 )	-77.14 ( 26.277 )	-50.15 ( 83.141 )	-72.98 ( 17.074 )	-52.99 ( 36.735 )	-41.18 ( 68.097 )
Week 36 (N= 13, 32, 10, 28, 12, 32, 7, 32, 14)	-65.76 ( 35.792 )	-48.12 ( 56.610 )	-60.50 ( 41.018 )	-35.86 ( 58.071 )	-79.13 ( 24.980 )	-52.16 ( 84.141 )	-78.26 ( 23.932 )	-49.48 ( 43.137 )	-45.04 ( 65.630 )
Week 40 (N= 13, 30, 11, 28, 11, 32, 7, 31, 14)	-69.26 ( 34.172 )	-44.78 ( 59.798 )	-58.29 ( 42.112 )	-36.52 ( 58.909 )	-72.31 ( 27.268 )	-46.41 ( 84.277 )	-83.18 ( 16.284 )	-49.75 ( 42.024 )	-38.69 ( 80.196 )
Week 44 (N= 13, 31, 11, 28, 12, 32, 7, 31, 14)	-63.03 ( 41.237 )	-45.33 ( 60.470 )	-63.04 ( 42.005 )	-33.25 ( 58.480 )	-76.32 ( 31.166 )	-39.27 ( 83.804 )	-60.44 ( 28.925 )	-49.15 ( 43.228 )	-48.21 ( 48.871 )
Week 48 (N= 13, 31, 10, 28, 12, 30, 7, 30, 14)	-59.02 ( 36.676 )	-45.68 ( 59.933 )	-63.97 ( 43.622 )	-35.98 ( 57.915 )	-73.10 ( 28.704 )	-40.20 ( 84.240 )	-70.04 ( 26.437 )	-50.82 ( 41.018 )	-57.92 ( 45.339 )
Week 52 (N= 13, 30, 11, 28, 11, 29, 7, 31, 14)	-53.62 ( 36.496 )	-43.64 ( 56.804 )	-61.04 ( 42.716 )	-33.21 ( 59.514 )	-72.35 ( 33.768 )	-35.27 ( 85.953 )	-71.56 ( 28.287 )	-49.24 ( 43.003 )	-57.12 ( 44.899 )

No statistical analyses for this end point

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

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End point title

Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

End point description

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 16 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on scale
arithmetic mean (standard deviation)
Week 16 (N= 67, 66, 73, 76, 68)	-6.70 ( 5.813 )	-5.41 ( 6.054 )	-6.22 ( 6.272 )	-6.61 ( 5.804 )	-2.50 ( 4.589 )
Week 24 (N= 65, 66, 70, 68, 67)	-7.35 ( 6.695 )	-5.80 ( 6.187 )	-6.70 ( 6.566 )	-6.66 ( 5.868 )	-1.90 ( 5.046 )

No statistical analyses for this end point

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

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End point title

Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

End point description

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to weeks 24, 36 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 28, 12, 27, 12, 31, 5, 31, 16)	-11.23 ( 6.071 )	-8.64 ( 5.927 )	-9.83 ( 6.506 )	-7.44 ( 5.673 )	-9.83 ( 5.132 )	-8.42 ( 6.386 )	-12.60 ( 6.986 )	-8.29 ( 5.996 )	-6.25 ( 6.083 )
Week 36 (N= 13, 30, 10, 27, 12, 31, 7, 31, 12)	-11.46 ( 5.681 )	-8.13 ( 6.463 )	-8.20 ( 6.143 )	-7.78 ( 6.123 )	-10.33 ( 5.483 )	-9.26 ( 6.875 )	-10.71 ( 6.550 )	-8.03 ( 6.385 )	-6.38 ( 6.063 )
Week 52 (N= 13, 30, 11, 27, 11, 29, 7, 29, 14)	-11.31 ( 4.768 )	-8.30 ( 5.706 )	-8.82 ( 6.809 )	-7.44 ( 6.594 )	-10.45 ( 5.989 )	-6.48 ( 6.539 )	-9.71 ( 4.751 )	-8.34 ( 6.893 )	-7.14 ( 6.125 )

No statistical analyses for this end point

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

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End point title

Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 16 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of change
arithmetic mean (standard deviation)
Week 16 (N= 67, 66, 73, 76, 68)	-40.56 ( 37.340 )	-33.42 ( 34.745 )	-36.42 ( 37.103 )	-38.72 ( 30.762 )	-17.04 ( 32.553 )
Week 24 (N= 65, 66, 70, 68, 67)	-45.18 ( 42.438 )	-36.20 ( 41.363 )	-40.45 ( 40.708 )	-39.35 ( 31.799 )	-12.31 ( 37.504 )

No statistical analyses for this end point

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

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End point title

Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

End point description

ADCT is a questionnaire to assess patient-self-perceived control of their eczema with a total score from 0 to 24; higher scores indicate lower AD control. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 36 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 28, 12, 27, 12, 31, 5, 31, 16)	-66.75 ( 32.632 )	-57.08 ( 37.656 )	-56.01 ( 36.112 )	-49.97 ( 34.078 )	-65.46 ( 26.823 )	-53.10 ( 40.207 )	-63.92 ( 29.784 )	-50.66 ( 33.458 )	-44.95 ( 45.331 )
Week 36 (N= 13, 30, 10, 27, 12, 31, 7, 31, 13)	-69.01 ( 29.493 )	-50.38 ( 42.649 )	-50.01 ( 37.199 )	-50.87 ( 33.197 )	-69.73 ( 28.925 )	-58.44 ( 43.340 )	-62.63 ( 23.130 )	-48.59 ( 38.274 )	-49.42 ( 45.902 )
Week 52 (N= 13, 30, 11, 27, 11, 29, 7, 29, 14)	-69.93 ( 26.250 )	-54.77 ( 34.128 )	-52.75 ( 41.167 )	-47.15 ( 39.681 )	-67.84 ( 32.469 )	-41.39 ( 43.875 )	-64.19 ( 28.274 )	-50.29 ( 41.341 )	-53.35 ( 47.196 )

No statistical analyses for this end point

Secondary: Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

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End point title

Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

End point description

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 8, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on a scale
arithmetic mean (standard deviation)
Week 8 (N= 70, 68, 74, 76, 72)	-2.20 ( 4.639 )	-2.07 ( 6.194 )	-2.35 ( 5.641 )	-3.29 ( 5.132 )	-0.97 ( 3.940 )
Week 16 (N= 67, 66, 73, 76, 68)	-2.67 ( 5.761 )	-2.53 ( 6.510 )	-3.04 ( 6.292 )	-3.74 ( 6.401 )	-0.57 ( 5.088 )
Week 20 (N= 66, 68, 72, 72, 67)	-2.52 ( 7.254 )	-2.35 ( 7.326 )	-3.38 ( 6.787 )	-4.24 ( 5.873 )	-0.66 ( 4.176 )
Week 24 (N= 70, 67, 70, 70, 67)	-2.96 ( 7.550 )	-2.30 ( 6.880 )	-2.83 ( 6.818 )	-4.00 ( 6.802 )	-0.97 ( 4.196 )

No statistical analyses for this end point

Secondary: Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

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End point title

Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

End point description

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints are reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 33, 12, 27, 12, 31, 5, 33, 16)	-4.54 ( 8.482 )	-1.73 ( 7.434 )	-5.58 ( 10.184 )	-2.81 ( 6.822 )	-3.67 ( 6.998 )	-4.42 ( 7.890 )	-8.20 ( 6.340 )	-4.03 ( 6.710 )	-0.38 ( 4.660 )
Week 28 (N= 13, 33, 12, 27, 12, 31, 7, 34, 13)	-3.54 ( 7.965 )	-2.52 ( 6.205 )	-6.50 ( 11.430 )	-2.70 ( 6.916 )	-4.33 ( 7.679 )	-4.97 ( 8.428 )	-7.29 ( 5.251 )	-5.26 ( 7.034 )	0.38 ( 4.753 )
Week 32 (N= 13, 33, 11, 27, 12, 32, 7, 32, 15)	-3.38 ( 8.893 )	-1.24 ( 6.996 )	-4.09 ( 9.027 )	-2.74 ( 7.593 )	-4.42 ( 7.242 )	-5.66 ( 8.280 )	-6.86 ( 5.460 )	-3.97 ( 6.483 )	-0.20 ( 4.491 )
Week 36 (N= 13, 32, 10, 27, 12, 32, 7, 32, 14)	-1.85 ( 9.754 )	-1.22 ( 8.015 )	-3.80 ( 10.497 )	-2.52 ( 5.833 )	-4.42 ( 6.999 )	-5.50 ( 8.828 )	-7.14 ( 4.880 )	-3.75 ( 7.878 )	0.29 ( 4.250 )
Week 40 (N= 13, 30, 11, 27, 11, 32, 7, 31, 14)	-2.92 ( 8.864 )	-1.40 ( 6.966 )	-3.09 ( 10.222 )	-2.70 ( 6.151 )	-3.55 ( 7.594 )	-5.16 ( 8.674 )	-7.43 ( 5.563 )	-3.29 ( 5.593 )	0.50 ( 5.125 )
Week 44 (N= 13, 31, 11, 27, 12, 32, 7, 31, 14)	-2.69 ( 8.873 )	-0.29 ( 6.963 )	-3.45 ( 10.511 )	-3.07 ( 5.313 )	-4.25 ( 7.225 )	-4.56 ( 8.879 )	-5.43 ( 5.192 )	-3.71 ( 7.408 )	-0.21 ( 4.318 )
Week 48 (N= 13, 31, 10, 27, 12, 30, 7, 30, 14)	-3.08 ( 8.883 )	-0.68 ( 7.078 )	-4.40 ( 10.024 )	-2.85 ( 5.559 )	-3.33 ( 7.797 )	-5.23 ( 8.724 )	-7.43 ( 5.412 )	-4.17 ( 7.269 )	-1.00 ( 4.852 )
Week 52 (N= 13, 30, 11, 27, 11, 29, 7, 31, 14)	-2.46 ( 9.162 )	-0.80 ( 7.092 )	-2.55 ( 8.359 )	-3.00 ( 5.877 )	-4.18 ( 7.167 )	-4.59 ( 8.454 )	-7.29 ( 5.794 )	-3.13 ( 8.082 )	-0.64 ( 5.719 )

No statistical analyses for this end point

Secondary: Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

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End point title

Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 8, 16, 20 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: Percentage of change
arithmetic mean (standard deviation)
Week 8 (N= 69, 66, 70, 76, 69)	-18.40 ( 46.151 )	-11.76 ( 48.829 )	-10.22 ( 56.395 )	-13.15 ( 69.427 )	-0.66 ( 77.969 )
Week 16 (N= 66, 65, 69, 76, 65)	-18.12 ( 56.175 )	-11.72 ( 54.678 )	-15.84 ( 54.001 )	-17.47 ( 94.346 )	2.82 ( 101.930 )
Week 20 (N= 65, 66, 68, 72, 64)	-20.15 ( 65.506 )	-7.39 ( 62.693 )	-17.62 ( 59.518 )	-25.97 ( 83.249 )	-5.02 ( 78.180 )
Week 24 (N= 69, 65, 66, 70, 64)	-13.22 ( 97.953 )	-8.67 ( 60.563 )	-17.75 ( 52.049 )	-12.07 ( 120.061 )	-8.17 ( 77.872 )

No statistical analyses for this end point

Secondary: Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

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End point title

Percentage Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)

End point description

The HADS is 14-item questionnaire with two subscales: anxiety & depression. Each subscale (anxiety & depression) ranges 0-21. The total HADS score ranges 0-42 with higher score indicating a poorer state. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: Percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 32, 11, 26, 11, 29, 5, 33, 16)	-28.01 ( 54.369 )	-17.89 ( 76.693 )	-34.27 ( 48.841 )	-13.63 ( 65.697 )	-20.28 ( 49.825 )	-32.24 ( 65.070 )	-46.94 ( 22.063 )	-22.38 ( 58.898 )	-32.55 ( 66.184 )
Week 28 (N= 13, 32, 11, 26, 11, 29, 7, 34, 13)	-18.57 ( 53.870 )	-22.56 ( 67.645 )	-30.97 ( 51.945 )	-17.92 ( 53.098 )	4.22 ( 96.782 )	-30.52 ( 66.305 )	-49.58 ( 31.509 )	-33.17 ( 41.412 )	-38.39 ( 77.030 )
Week 32 (N= 13, 32, 10, 26, 11, 30, 7, 32, 15)	-19.06 ( 60.844 )	-14.02 ( 82.893 )	-29.10 ( 52.035 )	-20.31 ( 63.189 )	-11.36 ( 87.084 )	-43.96 ( 68.306 )	-42.56 ( 27.759 )	-32.62 ( 49.764 )	-38.06 ( 69.176 )
Week 36 (N= 13, 31, 9, 26, 11, 30, 7, 32, 14)	11.76 ( 84.979 )	-9.44 ( 81.662 )	-6.28 ( 62.772 )	-22.30 ( 51.020 )	-8.75 ( 85.214 )	37.19 ( 71.372 )	-51.27 ( 29.960 )	-32.59 ( 49.531 )	-9.11 ( 110.289 )
Week 40 (N= 13, 29, 10, 26, 10, 30, 7, 31, 14)	-13.29 ( 60.249 )	-18.23 ( 79.025 )	7.25 ( 82.513 )	-21.32 ( 50.659 )	4.24 ( 91.941 )	-40.11 ( 67.991 )	-56.66 ( 33.879 )	-35.92 ( 46.888 )	-1.02 ( 98.096 )
Week 44 (N= 13, 30, 10, 26, 11, 30, 7, 31, 14)	-2.42 ( 54.527 )	-5.30 ( 88.418 )	-23.23 ( 56.824 )	-31.88 ( 49.100 )	-15.90 ( 85.382 )	-30.93 ( 71.891 )	-41.44 ( 37.143 )	-32.73 ( 57.357 )	-22.21 ( 80.062 )
Week 48 (N= 13, 30, 9, 26, 11, 28, 7, 30, 14)	-14.15 ( 60.660 )	-4.47 ( 95.509 )	-28.27 ( 51.499 )	-21.89 ( 53.010 )	4.97 ( 88.017 )	-39.36 ( 69.672 )	-60.77 ( 35.190 )	-36.32 ( 47.746 )	-34.95 ( 67.833 )
Week 52 (N= 13, 29, 10, 26, 11, 28, 7, 31, 14)	-8.10 ( 67.182 )	-7.59 ( 92.868 )	-13.70 ( 44.085 )	-19.98 ( 56.405 )	0.43 ( 85.522 )	-14.22 ( 78.739 )	-59.23 ( 37.434 )	-23.84 ( 50.933 )	-18.16 ( 69.310 )

No statistical analyses for this end point

Secondary: Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

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End point title

Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

End point description

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the ‘worst itch imaginable’. The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: score on a scale
arithmetic mean (standard deviation)
Week 1 (N= 74, 77, 77, 77, 77)	-0.54 ( 1.096 )	-0.56 ( 0.978 )	-0.49 ( 0.965 )	-0.45 ( 0.908 )	-0.28 ( 1.071 )
Week 2 (N= 75, 77, 76, 76, 77)	-0.65 ( 1.316 )	-0.79 ( 1.367 )	-0.73 ( 1.075 )	-0.81 ( 1.224 )	-0.42 ( 1.046 )
Week 3 (N= 75, 77, 77, 77, 76)	-0.90 ( 1.619 )	-0.92 ( 1.392 )	-1.05 ( 1.302 )	-0.88 ( 1.478 )	-0.65 ( 1.567 )
Week 4 (N= 75, 76, 76, 77, 77)	-.096 ( 1.672 )	-1.25 ( 1.657 )	-1.36 ( 1.443 )	-1.09 ( 1.668 )	-0.77 ( 1.744 )
Week 5 (N= 75, 75, 75, 77, 74)	-0.99 ( 1.811 )	-1.38 ( 1.653 )	-1.42 ( 1.591 )	-1.49 ( 1.799 )	-0.83 ( 2.030 )
Week 6 (N= 74, 73, 75, 76, 75)	-1.09 ( 1.679 )	-1.35 ( 1.818 )	-1.38 ( 1.666 )	-1.58 ( 2.057 )	-0.94 ( 1.899 )
Week 7 (N= 73, 72, 74, 76, 73)	-1.25 ( 1.966 )	-1.54 ( 1.850 )	-1.57 ( 1.710 )	-1.78 ( 2.002 )	-0.78 ( 1.922 )
Week 8 (N= 73, 72, 73, 75, 73)	-1.42 ( 2.062 )	-1.50 ( 1.786 )	-1.60 ( 1.816 )	-1.93 ( 2.053 )	-0.80 ( 1.979 )
Week 9 (N= 74, 73, 74, 75, 70)	-1.44 ( 2.104 )	-1.52 ( 1.805 )	-1.89 ( 1.885 )	-2.13 ( 2.031 )	-1.00 ( 2.142 )
Week 10 (N= 72, 73, 72, 74, 69)	-1.62 ( 2.162 )	-1.67 ( 1.852 )	-1.82 ( 2.082 )	-2.17 ( 2.137 )	-0.97 ( 2.244 )
Week 11 (N= 73, 70, 73, 74, 68)	-1.68 ( 2.176 )	-1.67 ( 1.936 )	-2.06 ( 2.091 )	-2.31 ( 2.248 )	-0.93 ( 2.111 )
Week 12 (N= 72, 69, 71, 73, 68)	-1.70 ( 2.204 )	-1.65 ( 2.074 )	-1.96 ( 2.107 )	-2.28 ( 2.262 )	-0.79 ( 2.162 )
Week 13 (N= 72, 71, 71, 73, 70)	-1.83 ( 2.295 )	-1.87 ( 2.247 )	-2.05 ( 2.164 )	-2.28 ( 2.291 )	-0.72 ( 2.087 )
Week 14 (N= 72, 70, 70, 75, 67)	-1.82 ( 2.355 )	-2.02 ( 2.468 )	-2.13 ( 2.308 )	-2.35 ( 2.316 )	-0.58 ( 2.055 )
Week 15 (N= 70, 69, 71, 74, 67)	-1.87 ( 2.386 )	-2.08 ( 2.511 )	-2.10 ( 2.290 )	-2.32 ( 2.288 )	-0.57 ( 2.018 )
Week 16 (N= 72, 68, 71, 75, 66)	-2.06 ( 2.539 )	-2.09 ( 2.497 )	-2.22 ( 2.275 )	-2.31 ( 2.301 )	-0.54 ( 2.077 )
Week 17 (N= 70, 68, 71, 75, 67)	-2.13 ( 2.465 )	-2.18 ( 2.457 )	-2.14 ( 2.368 )	-2.35 ( 2.346 )	-0.61 ( 2.143 )
Week 18 (N= 70, 68, 68, 75, 66)	-2.18 ( 2.534 )	-2.21 ( 2.543 )	-2.16 ( 2.307 )	-2.37 ( 2.383 )	-0.55 ( 2.168 )
Week 19 (N= 69, 67, 70, 75, 67)	-2.19 ( 2.484 )	-2.22 ( 2.563 )	-2.14 ( 2.291 )	-2.38 ( 2.463 )	-0.75 ( 2.278 )
Week 20 (N= 68, 67, 69, 72, 67)	-2.28 ( 2.522 )	-2.19 ( 2.530 )	-2.13 ( 2.360 )	-2.31 ( 2.401 )	-0.67 ( 2.201 )
Week 21 (N= 69, 68, 70, 72, 67)	-2.28 ( 2.516 )	-2.23 ( 2.576 )	-2.27 ( 2.352 )	-2.43 ( 2.404 )	-0.76 ( 2.332 )
Week 22 (N= 69, 66, 69, 72, 67)	-2.38 ( 2.622 )	-2.29 ( 2.699 )	-2.25 ( 2.438 )	-2.44 ( 2.383 )	-0.73 ( 2.314 )
Week 23 (N= 70, 67, 70, 71, 67)	-2.56 ( 2.671 )	-2.27 ( 2.538 )	-2.20 ( 2.529 )	-2.59 ( 2.453 )	-0.61 ( 2.215 )
Week 24 (N= 70, 66, 70, 71, 67)	-2.58 ( 2.662 )	-2.30 ( 2.672 )	-2.21 ( 2.616 )	-2.46 ( 2.427 )	-0.55 ( 2.224 )

No statistical analyses for this end point

Secondary: Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

Top of page

End point title

Absolute Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

End point description

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the ‘worst itch imaginable’. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 26, 11, 33, 6, 33, 16)	-3.63 ( 2.380 )	-2.83 ( 2.909 )	-4.00 ( 2.711 )	-2.25 ( 2.861 )	-4.34 ( 2.169 )	-2.92 ( 2.539 )	-4.63 ( 1.822 )	-2.82 ( 2.571 )	-1.95 ( 3.083 )
Week 25 (N= 13, 34, 12, 25, 12, 31, 6, 33, 15)	-3.83 ( 2.353 )	-2.73 ( 2.973 )	-4.08 ( 2.726 )	-2.42 ( 2.895 )	-4.12 ( 2.413 )	-2.81 ( 2.405 )	-4.92 ( 1.863 )	-2.64 ( 2.577 )	-2.08 ( 3.177 )
Week 26 (N= 13, 33, 12, 25, 11, 30, 7, 33, 15)	-3.82 ( 2.442 )	-2.71 ( 2.891 )	-3.75 ( 2.654 )	-2.33 ( 3.096 )	-3.83 ( 2.428 )	-2.56 ( 2.400 )	-4.56 ( 1.903 )	-2.70 ( 2.634 )	-1.93 ( 3.202 )
Week 27 (N= 13, 33, 12, 24, 11, 30, 7, 33, 14)	-3.84 ( 2.444 )	-2.58 ( 2.819 )	-3.65 ( 2.619 )	-2.28 ( 2.994 )	-4.09 ( 2.567 )	-2.84 ( 2.467 )	-4.51 ( 1.790 )	-2.57 ( 2.748 )	-2.04 ( 3.351 )
Week 28 (N= 13, 33, 12, 26, 11, 31, 7, 32, 14)	-3.86 ( 2.432 )	-2.56 ( 2.892 )	-3.59 ( 2.575 )	-2.29 ( 2.782 )	-4.02 ( 2.525 )	-3.01 ( 2.504 )	-4.38 ( 1.827 )	-2.75 ( 2.753 )	-1.89 ( 3.459 )
Week 29 (N= 13, 32, 11, 25, 12, 31, 7, 31, 14)	-3.73 ( 2.612 )	-2.51 ( 2.874 )	-3.81 ( 2.425 )	-1.85 ( 2.733 )	-4.16 ( 2.387 )	-2.99 ( 2.591 )	-4.50 ( 2.035 )	-2.64 ( 2.695 )	-1.81 ( 3.386 )
Week 30 (N= 13, 34, 11, 27, 12, 31, 6, 32, 13)	-3.32 ( 2.564 )	-2.78 ( 3.030 )	-3.76 ( 2.394 )	-2.07 ( 2.564 )	-4.44 ( 2.526 )	-2.68 ( 2.490 )	-3.73 ( 2.125 )	-2.59 ( 2.653 )	-1.80 ( 3.445 )
Week 31 (N= 13, 32, 11, 26, 12, 31, 6, 33, 15)	-3.41 ( 2.580 )	-2.74 ( 3.213 )	-3.73 ( 2.431 )	-1.71 ( 2.980 )	-4.18 ( 2.428 )	-2.81 ( 2.662 )	-4.02 ( 2.280 )	-2.78 ( 2.691 )	-1.46 ( 3.132 )
Week 32 (N= 13, 34, 11, 25, 12, 32, 7, 33, 14)	-3.43 ( 2.607 )	-2.56 ( 3.098 )	-3.13 ( 2.818 )	-1.51 ( 2.736 )	-4.27 ( 2.261 )	-2.86 ( 2.617 )	-4.40 ( 2.170 )	-2.68 ( 2.674 )	-1.54 ( 3.221 )
Week 33 (N= 13, 34, 11, 26, 12, 32, 7, 33, 14)	-3.60 ( 2.722 )	-2.49 ( 3.220 )	-3.06 ( 2.755 )	-1.85 ( 2.867 )	-4.32 ( 2.316 )	-2.83 ( 2.579 )	-4.14 ( 1.843 )	-2.66 ( 2.705 )	-1.45 ( 3.332 )
Week 34 (N= 13, 33, 11, 26, 12, 31, 7, 32, 13)	-3.49 ( 2.644 )	-2.26 ( 3.114 )	-3.32 ( 2.732 )	-1.30 ( 2.792 )	-4.43 ( 2.297 )	-2.84 ( 2.508 )	-3.97 ( 1.948 )	-2.58 ( 2.665 )	-1.86 ( 3.578 )
Week 35 (N= 13, 34, 11, 27, 12, 32, 7, 31, 14)	-3.47 ( 2.712 )	-2.51 ( 3.219 )	-3.09 ( 2.600 )	-1.42 ( 2.685 )	-4.60 ( 2.497 )	-3.01 ( 2.529 )	-4.55 ( 2.055 )	-2.65 ( 2.674 )	-1.86 ( 3.390 )
Week 36 (N= 13, 34, 11, 27, 12, 32, 7, 30, 14)	-3.48 ( 2.752 )	-2.47 ( 3.262 )	-2.81 ( 2.693 )	-1.64 ( 2.670 )	-4.67 ( 2.468 )	-2.90 ( 2.527 )	-4.14 ( 1.845 )	-2.39 ( 2.626 )	-1.56 ( 3.318 )
Week 37 (N= 13, 34, 11, 27, 12, 31, 7, 30, 14)	-3.44 ( 2.726 )	-2.53 ( 3.244 )	-2.50 ( 2.523 )	-1.85 ( 2.758 )	-4.51 ( 2.429 )	-3.11 ( 2.508 )	-4.49 ( 1.992 )	-2.33 ( 2.564 )	-1.58 ( 3.328 )
Week 38 (N= 13, 33, 11, 26, 12, 32, 7, 30, 13)	-3.31 ( 3.182 )	-2.33 ( 3.159 )	-2.06 ( 2.464 )	-1.74 ( 2.803 )	-4.57 ( 2.505 )	-3.16 ( 2.672 )	-4.52 ( 2.046 )	-2.37 ( 2.548 )	-1.64 ( 3.449 )
Week 39 (N= 13, 32, 11, 26, 12, 32, 7, 29, 14)	-3.34 ( 3.206 )	-2.35 ( 3.212 )	-2.52 ( 2.462 )	-1.81 ( 2.792 )	-4.24 ( 2.451 )	-3.07 ( 2.548 )	-4.66 ( 2.070 )	-2.27 ( 2.605 )	-1.78 ( 3.350 )
Week 40 (N= 13, 32, 10, 26, 12, 32, 6, 29, 14)	-3.29 ( 3.245 )	-2.26 ( 3.208 )	-2.11 ( 2.064 )	-1.74 ( 2.697 )	-4.24 ( 2.419 )	-2.92 ( 2.574 )	-2.98 ( 1.946 )	-2.38 ( 2.659 )	-1.67 ( 3.413 )
Week 41 (N= 13, 32, 9, 26, 12, 31, 7, 29, 13)	-3.25 ( 3.188 )	-2.26 ( 3.213 )	-1.82 ( 1.991 )	-1.97 ( 2.774 )	-4.56 ( 2.344 )	-2.67 ( 2.798 )	-3.73 ( 2.142 )	-2.41 ( 2.697 )	-1.64 ( 3.856 )
Week 42 (N= 13, 32, 11, 27, 12, 32, 7, 30, 13)	-3.21 ( 3.218 )	-2.28 ( 3.307 )	-2.53 ( 2.603 )	-1.91 ( 2.835 )	-4.67 ( 2.494 )	-2.92 ( 2.876 )	-3.78 ( 2.183 )	-2.24 ( 2.655 )	-2.01 ( 3.719 )
Week 43 (N= 13, 32, 11, 27, 12, 32, 7, 30, 12)	-3.30 ( 3.246 )	-2.27 ( 3.158 )	-2.53 ( 2.523 )	-1.74 ( 2.821 )	-4.64 ( 2.864 )	-2.82 ( 2.612 )	-3.70 ( 2.063 )	-2.22 ( 2.736 )	-2.31 ( 3.823 )
Week 44 (N= 13, 32, 11, 27, 12, 32, 7, 30, 13)	-3.34 ( 3.276 )	-2.31 ( 3.196 )	-2.37 ( 2.349 )	-1.79 ( 2.690 )	-4.83 ( 2.484 )	-2.81 ( 2.693 )	-3.51 ( 2.084 )	-2.21 ( 2.656 )	-2.01 ( 3.730 )
Week 45 (N= 12, 32, 10, 27, 12, 31, 7, 30, 13)	-3.63 ( 3.034 )	-2.41 ( 3.267 )	-1.97 ( 2.110 )	-1.87 ( 2.745 )	-4.68 ( 2.637 )	-2.62 ( 2.636 )	-3.58 ( 1.992 )	-2.23 ( 2.678 )	-1.87 ( 3.752 )
Week 46 (N= 12, 32, 10, 27, 12, 31, 7, 29, 11)	-3.29 ( 3.359 )	-2.46 ( 3.219 )	-2.61 ( 2.550 )	-1.84 ( 2.679 )	-4.41 ( 2.864 )	-2.33 ( 2.614 )	-3.78 ( 2.146 )	-2.28 ( 2.713 )	-1.99 ( 4.071 )
Week 47 (N= 12, 32, 9, 27, 12, 31, 7, 30, 13)	-3.17 ( 3.283 )	-2.31 ( 3.183 )	-1.95 ( 2.320 )	-1.84 ( 2.796 )	-4.46 ( 2.830 )	-2.30 ( 2.731 )	-3.66 ( 2.139 )	-2.38 ( 2.645 )	-1.78 ( 3.762 )
Week 48 (N= 12, 32, 9, 27, 12, 30, 7, 29, 13)	-2.82 ( 3.247 )	-2.43 ( 3.202 )	-2.36 ( 2.366 )	-1.84 ( 2.761 )	-4.64 ( 2.892 )	-2.04 ( 2.636 )	-3.96 ( 2.251 )	-2.31 ( 2.731 )	-2.05 ( 3.716 )
Week 49 (N= 12, 31, 10, 27, 12, 30, 7, 30, 12)	-2.80 ( 3.230 )	-2.27 ( 3.139 )	-2.66 ( 2.610 )	-2.02 ( 2.909 )	-4.68 ( 2.893 )	-2.02 ( 2.625 )	-3.65 ( 1.938 )	-2.46 ( 2.847 )	-2.06 ( 3.875 )
Week 50 (N= 12, 31, 10, 27, 12, 29, 7, 30, 12)	-2.78 ( 3.223 )	-2.23 ( 3.218 )	-2.44 ( 2.699 )	-1.90 ( 2.913 )	-4.56 ( 2.923 )	-1.87 ( 2.596 )	-3.78 ( 2.092 )	-2.35 ( 2.788 )	-2.16 ( 3.870 )
Week 51 (N= 12, 30, 10, 27, 11, 29, 7, 30, 12)	-2.67 ( 3.188 )	-2.42 ( 3.317 )	-2.39 ( 2.399 )	-1.80 ( 2.860 )	-4.64 ( 3.094 )	-1.89 ( 2.692 )	-3.66 ( 2.014 )	-2.40 ( 2.777 )	-2.12 ( 3.883 )
Week 52 (N= 12, 30, 9, 27, 12, 29, 7, 30, 12)	-2.70 ( 3.119 )	-2.17 ( 3.152 )	-2.53 ( 2.917 )	-1.84 ( 2.779 )	-4.74 ( 2.909 )	-1.84 ( 2.929 )	-3.86 ( 2.135 )	-2.33 ( 2.811 )	-2.12 ( 3.904 )

No statistical analyses for this end point

Secondary: Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

Top of page

End point title

Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: Percentage of change
arithmetic mean (standard deviation)
Week 1 (N= 74, 77, 77, 77, 77)	-6.26 ( 16.312 )	-7.25 ( 13.575 )	-6.18 ( 13.809 )	-6.05 ( 13.049 )	-3.70 ( 16.432 )
Week 2 (N= 75, 77, 76, 76, 77)	-7.50 ( 20.644 )	-10.37 ( 19.307 )	-9.86 ( 14.734 )	-11.20 ( 18.124 )	-5.63 ( 15.340 )
Week 3 (N= 75, 77, 77, 77, 76)	-11.08 ( 24.712 )	-12.11 ( 18.977 )	-14.11 ( 17.784 )	-12.08 ( 22.244 )	-7.89 ( 22.004 )
Week 4 (N= 75, 76, 76, 77, 77)	-12.16 ( 25.287 )	-16.73 ( 22.997 )	-18.37 ( 19.932 )	-14.95 ( 24.356 )	-9.83 ( 24.266 )
Week 5 (N= 75, 75, 75, 77, 74)	-12.58 ( 27.613 )	-18.64 ( 23.725 )	-19.20 ( 21.900 )	-20.17 ( 25.112 )	-10.14 ( 29.071 )
Week 6 (N= 74, 73, 75, 76, 75)	-13.73 ( 25.374 )	-17.59 ( 25.814 )	-18.68 ( 22.790 )	-21.29 ( 28.179 )	-12.43 ( 27.184 )
Week 7 (N= 73, 72, 74, 76, 73)	-15.89 ( 28.992 )	-20.18 ( 25.476 )	-21.18 ( 23.816 )	-24.03 ( 27.650 )	-10.18 ( 28.308 )
Week 8 (N= 73, 72, 73, 75, 73)	-18.41 ( 31.375 )	-19.99 ( 24.992 )	-21.14 ( 24.981 )	-26.10 ( 27.810 )	-10.51 ( 29.803 )
Week 9 (N= 74, 73, 74, 75, 70)	-18.83 ( 32.003 )	-20.36 ( 25.407 )	-25.45 ( 24.895 )	-29.18 ( 27.455 )	-13.34 ( 32.225 )
Week 10 (N= 72, 73, 72, 74, 69)	-21.19 ( 32.110 )	-22.53 ( 25.815 )	-24.46 ( 28.280 )	-29.43 ( 28.109 )	-12.99 ( 33.194 )
Week 11 (N= 73, 70, 73, 74, 68)	-21.93 ( 31.966 )	-22.37 ( 26.321 )	-27.67 ( 28.079 )	-31.26 ( 29.641 )	-12.73 ( 31.638 )
Week 12 (N= 72, 69, 71, 73, 68)	-22.59 ( 32.927 )	-22.05 ( 28.445 )	-26.52 ( 28.426 )	-31.23 ( 30.323 )	-10.62 ( 32.707 )
Week 13 (N= 72, 71, 71, 73, 70)	-23.88 ( 33.561 )	-24.71 ( 30.761 )	-28.18 ( 29.401 )	-31.36 ( 31.724 )	-10.05 ( 32.122 )
Week 14 (N= 72, 70, 70, 75, 67)	-23.87 ( 34.926 )	-26.45 ( 32.870 )	-29.19 ( 30.904 )	-32.57 ( 31.719 )	-7.60 ( 31.351 )
Week 15 (N= 70, 69, 71, 74, 67)	-24.40 ( 34.899 )	-27.46 ( 33.838 )	-28.87 ( 31.207 )	-32.01 ( 30.980 )	-6.87 ( 29.583 )
Week 16 (N= 72, 68, 71, 75, 66)	-26.85 ( 36.332 )	-27.92 ( 33.619 )	-30.75 ( 30.460 )	-31.97 ( 31.194 )	-6.62 ( 30.591 )
Week 17 (N= 70, 68, 71, 75, 67)	-27.81 ( 35.262 )	-29.27 ( 33.331 )	-29.68 ( 31.753 )	-32.60 ( 31.851 )	-7.46 ( 31.529 )
Week 18 (N= 70, 68, 68, 75, 66)	-28.78 ( 36.738 )	-29.49 ( 34.514 )	-29.89 ( 31.200 )	-32.50 ( 32.096 )	-6.37 ( 31.752 )
Week 19 (N= 69, 67, 70, 75, 67)	-28.98 ( 36.372 )	-29.78 ( 35.087 )	-29.83 ( 31.632 )	-32.77 ( 33.698 )	-9.50 ( 33.411 )
Week 20 (N= 68, 67, 69, 72, 67)	-30.61 ( 37.215 )	-29.30 ( 34.365 )	-29.48 ( 32.361 )	-31.85 ( 32.767 )	-8.56 ( 32.725 )
Week 21 (N= 69, 68, 70, 72, 67)	-30.40 ( 36.928 )	-29.63 ( 34.869 )	-31.61 ( 32.551 )	-33.20 ( 33.098 )	-9.71 ( 34.201 )
Week 22 (N= 69, 66, 69, 72, 67)	-31.81 ( 38.100 )	-30.35 ( 36.881 )	-31.15 ( 33.763 )	-33.28 ( 32.108 )	-9.36 ( 34.161 )
Week 23 (N= 70, 67, 70, 71, 67)	-34.26 ( 38.693 )	-30.30 ( 35.236 )	-30.52 ( 35.354 )	-35.25 ( 33.102 )	-7.23 ( 32.486 )
Week 24 (N= 70, 66, 70, 71, 67)	-34.70 ( 38.656 )	-30.44 ( 36.696 )	-30.64 ( 36.647 )	-33.26 ( 32.433 )	-6.66 ( 32.550 )

No statistical analyses for this end point

Secondary: Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

Top of page

End point title

Percent Change in Weekly Average of Pruritus Numerical Rating Scale (NRS) From Baseline (Part 2)

End point description

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the ‘worst itch imaginable’. The Full Analysis Set (FAS2) for Part 2 included all re-randomized participants at Week 24. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 26, 11, 33, 6, 33, 16)	-49.61 ( 33.036 )	-38.71 ( 44.259 )	-52.36 ( 33.258 )	-29.76 ( 40.611 )	-56.60 ( 24.568 )	-42.27 ( 36.685 )	-59.49 ( 22.140 )	-38.95 ( 34.963 )	-29.09 ( 44.653 )
Week 25 (N= 13, 34, 12, 25, 12, 31, 6, 33, 15)	-52.15 ( 31.579 )	-36.78 ( 45.402 )	-53.26 ( 33.810 )	-31.69 ( 40.647 )	-54.31 ( 29.223 )	-41.26 ( 34.643 )	-63.84 ( 23.417 )	-37.04 ( 36.046 )	-30.81 ( 46.001 )
Week 26 (N= 13, 33, 12, 25, 11, 30, 7, 33, 15)	-51.62 ( 32.197 )	-36.84 ( 44.342 )	-48.88 ( 32.071 )	-30.68 ( 42.883 )	-50.31 ( 29.134 )	-38.14 ( 35.393 )	-57.52 ( 22.280 )	-37.71 ( 37.451 )	-28.48 ( 46.252 )
Week 27 (N= 13, 33, 12, 24, 11, 30, 7, 33, 14)	-52.09 ( 32.613 )	-35.34 ( 44.056 )	-47.36 ( 30.909 )	-29.42 ( 40.379 )	-53.62 ( 30.255 )	-42.65 ( 36.665 )	-57.00 ( 20.810 )	-35.32 ( 38.963 )	-29.92 ( 48.506 )
Week 28 (N= 13, 33, 12, 26, 11, 31, 7, 32, 14)	-52.36 ( 32.642 )	-34.80 ( 45.063 )	-47.19 ( 31.551 )	-30.58 ( 38.398 )	-53.08 ( 30.684 )	-44.86 ( 36.493 )	-56.28 ( 24.247 )	-38.37 ( 38.703 )	-27.74 ( 49.936 )
Week 29 (N= 13, 32, 11, 25, 12, 31, 7, 31, 14)	-50.48 ( 35.634 )	-34.13 ( 44.735 )	-50.29 ( 29.286 )	-24.35 ( 38.746 )	-54.93 ( 28.705 )	-44.31 ( 37.579 )	-56.79 ( 23.453 )	-36.46 ( 38.211 )	-26.40 ( 48.994 )
Week 30 (N= 13, 34, 11, 27, 12, 31, 6, 32, 13)	-44.79 ( 34.219 )	-37.91 ( 46.288 )	-49.35 ( 28.435 )	-28.00 ( 35.916 )	-58.70 ( 30.600 )	-40.30 ( 37.098 )	-48.05 ( 24.892 )	-36.03 ( 38.742 )	-26.58 ( 49.832 )
Week 31 (N= 13, 32, 11, 26, 12, 31, 6, 33, 15	-46.03 ( 34.355 )	-37.18 ( 49.311 )	-49.01 ( 28.581 )	-21.78 ( 41.439 )	-55.77 ( 30.420 )	-42.26 ( 39.161 )	-52.67 ( 29.311 )	-39.45 ( 38.697 )	-21.51 ( 44.331 )
Week 32 (N= 13, 34, 11, 25, 12, 32, 7, 33, 14)	-46.40 ( 35.233 )	-34.68 ( 47.719 )	-40.69 ( 34.523 )	-19.61 ( 37.935 )	-57.32 ( 29.140 )	-42.64 ( 38.113 )	-56.51 ( 27.668 )	-37.63 ( 38.453 )	-22.64 ( 46.122 )
Week 33 (N= 13, 34, 11, 26, 12, 32, 7, 33, 14)	-48.66 ( 36.625 )	-33.52 ( 48.881 )	-39.31 ( 33.036 )	-24.61 ( 40.379 )	-57.76 ( 29.406 )	-42.45 ( 38.100 )	-52.89 ( 22.337 )	-37.50 ( 39.368 )	-21.49 ( 48.348 )
Week 34 (N= 13, 33, 11, 26, 12, 31, 7, 32, 13)	-47.09 ( 35.098 )	-30.56 ( 48.227 )	-43.33 ( 34.277 )	-17.18 ( 39.855 )	-59.41 ( 29.414 )	-42.96 ( 37.718 )	-50.34 ( 22.937 )	-35.63 ( 37.586 )	-27.22 ( 51.629 )
Week 35 (N= 13, 34, 11, 27, 12, 32, 7, 31, 14)	-46.67 ( 36.047 )	-33.99 ( 48.416 )	-40.21 ( 32.239 )	-18.51 ( 37.670 )	-61.70 ( 32.381 )	-44.99 ( 37.080 )	-58.12 ( 24.772 )	-36.74 ( 37.592 )	-27.11 ( 48.897 )
Week 36 (N= 13, 34, 11, 27, 12, 32, 7, 30, 14)	-46.63 ( 36.326 )	-33.43 ( 48.720 )	-36.23 ( 33.872 )	-22.43 ( 37.322 )	-62.54 ( 31.831 )	-43.37 ( 37.251 )	-52.78 ( 22.120 )	-33.66 ( 38.520 )	-22.57 ( 47.897 )
Week 37 (N= 13, 34, 11, 27, 12, 31, 7, 30, 14)	-45.95 ( 35.161 )	-34.42 ( 48.542 )	-32.60 ( 31.909 )	-25.63 ( 39.489 )	-60.49 ( 31.510 )	-46.52 ( 37.336 )	-58.05 ( 27.565 )	-33.22 ( 38.367 )	-22.63 ( 48.038 )
Week 38 (N= 13, 33, 11, 26, 12, 32, 7, 30, 13)	-43.12 ( 42.814 )	-31.62 ( 47.534 )	-26.80 ( 31.244 )	-24.20 ( 40.063 )	-60.83 ( 31.559 )	-47.17 ( 39.147 )	-58.43 ( 27.410 )	-33.72 ( 37.516 )	-24.07 ( 49.645 )
Week 39 (N= 13, 32, 11, 26, 12, 32, 7, 29, 14)	-43.54 ( 42.937 )	-31.75 ( 48.313 )	-32.75 ( 31.185 )	-25.49 ( 40.126 )	-56.79 ( 31.763 )	-46.10 ( 38.082 )	-59.36 ( 25.162 )	-32.70 ( 38.945 )	-25.98 ( 48.229 )
Week 40 (N= 13, 32, 10, 26, 12, 32, 6, 29, 14)	-42.94 ( 43.748 )	-30.52 ( 48.657 )	-27.37 ( 25.233 )	-24.24 ( 38.972 )	-56.78 ( 31.397 )	-43.62 ( 38.048 )	-38.57 ( 22.074 )	-34.20 ( 39.168 )	-24.22 ( 49.044 )
Week 41 (N= 13, 32, 9, 26, 12, 31, 7, 29, 13)	-42.33 ( 43.065 )	-30.85 ( 48.900 )	-22.99 ( 23.218 )	-27.38 ( 39.966 )	-61.18 ( 30.487 )	-39.66 ( 42.054 )	-47.95 ( 26.092 )	-34.51 ( 40.123 )	-24.13 ( 55.219 )
Week 42 (N= 13, 32, 11, 27, 12, 32, 7, 30, 13)	-41.68 ( 42.874 )	-30.76 ( 50.332 )	-34.23 ( 35.319 )	-26.33 ( 40.513 )	-62.53 ( 32.149 )	-42.91 ( 42.866 )	-49.33 ( 29.448 )	-32.01 ( 39.405 )	-29.48 ( 53.423 )
Week 43 (N= 13, 32, 11, 27, 12, 32, 7, 30, 12)	-42.86 ( 43.495 )	-30.51 ( 48.200 )	-33.86 ( 33.053 )	-23.93 ( 40.455 )	-62.27 ( 36.647 )	-41.66 ( 38.115 )	-48.09 ( 26.148 )	-31.34 ( 41.919 )	-33.70 ( 54.865 )
Week 44 (N= 13, 32, 11, 27, 12, 32, 7, 30, 13)	-43.47 ( 44.000 )	-31.71 ( 49.607 )	-31.76 ( 30.960 )	-24.67 ( 37.725 )	-64.61 ( 31.787 )	-42.36 ( 40.085 )	-46.04 ( 28.399 )	-31.28 ( 40.103 )	-29.07 ( 53.672 )
Week 45 (N= 12, 32, 10, 27, 12, 31, 7, 30, 13)	-47.27 ( 40.996 )	-33.33 ( 50.319 )	-25.91 ( 26.492 )	-25.91 ( 38.680 )	-61.59 ( 33.745 )	-39.63 ( 39.211 )	-47.19 ( 28.645 )	-31.41 ( 39.716 )	-27.07 ( 54.016 )
Week 46 (N= 12, 32, 10, 27, 12, 31, 7, 29, 11)	-42.11 ( 45.119 )	-33.68 ( 49.356 )	-34.27 ( 33.932 )	-25.58 ( 38.019 )	-58.81 ( 35.801 )	-34.77 ( 38.757 )	-49.76 ( 30.190 )	-31.98 ( 39.640 )	-28.89 ( 58.573 )
Week 47 (N= 12, 32, 9, 27, 12, 31, 7, 30, 13)	-40.77 ( 44.580 )	-31.88 ( 48.778 )	-25.60 ( 30.211 )	-25.44 ( 39.798 )	-59.01 ( 35.211 )	-33.49 ( 39.386 )	-48.45 ( 30.519 )	-33.71 ( 38.282 )	-25.86 ( 54.094 )
Week 48 (N= 12, 32, 9, 27, 12, 30, 7, 29, 13)	-36.53 ( 44.443 )	-33.50 ( 48.912 )	-30.33 ( 30.351 )	-25.04 ( 38.230 )	-61.01 ( 35.650 )	-29.89 ( 38.681 )	-51.75 ( 30.214 )	-33.16 ( 40.239 )	-29.29 ( 53.432 )
Week 49 (N= 12, 31, 10, 27, 12, 30, 7, 30, 12)	-36.53 ( 44.233 )	-31.23 ( 48.493 )	-34.64 ( 34.631 )	-28.21 ( 41.352 )	-61.21 ( 35.897 )	-29.37 ( 38.374 )	-48.17 ( 27.760 )	-34.32 ( 41.018 )	-29.80 ( 55.717 )
Week 50 (N= 12, 31, 10, 27, 12, 29, 7, 30, 12)	-36.14 ( 44.279 )	-31.62 ( 50.758 )	-32.01 ( 36.290 )	-26.10 ( 40.637 )	-59.59 ( 36.330 )	-27.45 ( 38.441 )	-50.18 ( 30.773 )	-32.86 ( 40.330 )	-31.15 ( 55.571 )
Week 51 (N= 12, 30, 10, 27, 11, 29, 7, 30, 12)	-34.31 ( 43.008 )	-34.07 ( 51.575 )	-30.83 ( 31.211 )	-24.47 ( 39.779 )	-60.72 ( 38.664 )	-27.10 ( 39.790 )	-48.66 ( 29.191 )	-33.72 ( 40.790 )	-30.75 ( 55.841 )
Week 52 (N= 12, 30, 9, 27, 12, 29, 7, 30, 12)	-35.06 ( 42.961 )	-30.54 ( 49.791 )	-33.29 ( 38.191 )	-25.37 ( 39.165 )	-61.83 ( 35.861 )	-25.94 ( 43.683 )	-50.89 ( 29.752 )	-32.36 ( 40.612 )	-30.50 ( 56.024 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)

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End point title

Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 3 With a Baseline Pruritus NRS ≥ 3 From Baseline (Part 1)

End point description

End point type

Secondary

End point timeframe

Baseline to Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23 and 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	79	79
Units: percentage of participants
number (not applicable)
Week 1	2.6	1.3	1.3	1.3	1.3
Week 2	3.9	6.4	1.3	6.3	2.5
Week 3	9.1	6.4	10.4	76	6.3
Week 4	10.4	14.1	15.6	13.9	7.6
Week 5	15.6	15.4	16.9	19.0	11.4
Week 6	10.4	19.2	18.2	21.5	12.7
Week 7	16.9	23.1	20.8	25.3	11.4
Week 8	22.1	17.9	22.1	26.6	15.2
Week 9	20.8	19.2	27.3	31.6	13.9
Week 10	27.3	23.1	28.6	38.0	15.2
Week 11	26.0	23.1	31.2	36.7	13.9
Week 12	26.0	20.5	28.6	38.0	16.5
Week 13	28.6	26.9	29.9	38.0	13.9
Week 14	35.1	29.5	28.6	40.5	13.9
Week 15	29.9	28.2	28.6	40.5	10.1
Week 16	32.5	33.3	29.9	41.8	10.1
Week 17	32.5	30.8	27.3	38.0	13.9
Week 18	36.4	33.3	29.9	43.0	12.7
Week 19	35.1	32.1	33.8	43.0	15.2
Week 20	33.8	30.8	31.2	36.7	10.1
Week 21	37.7	32.1	33.8	36.7	15.2
Week 22	37.7	30.8	33.8	39.2	13.9
Week 23	41.6	35.9	37.7	43.0	12.7
Week 24	40.3	30.8	36.4	39.2	11.4

No statistical analyses for this end point

Secondary: Loss of EASI 50 Incidence Rate Per Patient Year (Part 2)

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End point title

Loss of EASI 50 Incidence Rate Per Patient Year (Part 2)

End point description

End point type

Secondary

End point timeframe

Week 24 to Week 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	13	7	35	16
Units: Incidence rate
number (not applicable)
Loss of EASI 50 Incidence Rate Per Patient Year	0	0.272	0.188	0.089	0.165	0.071	0	0.193	0.145

No statistical analyses for this end point

Secondary: Loss of EASI 75 Incidence Rate Per Patient Year (Part 2)

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End point title

Loss of EASI 75 Incidence Rate Per Patient Year (Part 2)

End point description

End point type

Secondary

End point timeframe

Week 24 to Week 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: Incidence rate
number (not applicable)
Loss of EASI 75 Incidence Rate Per Patient Year	0	0.587	0.375	0.486	0.395	0.446	0.351	0.573	0.646

No statistical analyses for this end point

Secondary: Loss of IGA 0/1 Incidence Rate Per Patient Year (Participants With a Response of 0 or 1 in IGA) (Part 2)

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End point title

Loss of IGA 0/1 Incidence Rate Per Patient Year (Participants With a Response of 0 or 1 in IGA) (Part 2)

End point description

End point type

Secondary

End point timeframe

Week 24 to Week 68

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: Incidence rate
number (not applicable)
Loss of IGA 0/1 Incidence Rate Per Patient Year	1.267	1.039	0.981	1.930	1.154	1.045	1.096	1.790	0.244

No statistical analyses for this end point

Secondary: Serum KY1005 Concentration Assessed Throughout the Study (Part 1)

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End point title

Serum KY1005 Concentration Assessed Throughout the Study (Part 1) ^[1]

End point description

This analysis was conducted for Part 1 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints were reported.

End point type

Secondary

End point timeframe

Baseline and at Weeks 1, 2, 4, 8, 12, 16, 17, 20 and 24

Notes
[1] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Serum KY1005 Concentration test is not applicable for Placebo arm.

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)
Number of subjects analysed	77	76	77	77
Units: ug/ml
arithmetic mean (standard deviation)
Baseline (N= 77, 74, 76, 73)	0.00 ( 0.014 )	0.00 ( 0.014 )	0.01 ( 0.074 )	0.00 ( 0.000 )
Week 1 (N= 72, 73, 74, 73)	58.29 ( 24.674 )	30.49 ( 18.520 )	14.18 ( 5.060 )	8.49 ( 3.331 )
Week 2 (N= 65, 69, 67, 70)	47.56 ( 17.274 )	25.09 ( 9.041 )	13.56 ( 3.886 )	7.57 ( 2.947 )
Week 4 (N= 62, 65, 69, 68)	38.49 ( 22.532 )	19.00 ( 7.869 )	9.67 ( 3.728 )	5.09 ( 2.176 )
Week 8 (N= 53, 48, 56, 61)	37.67 ( 15.157 )	32.14 ( 16.502 )	15.07 ( 6.383 )	7.92 ( 3.263 )
Week 12 (N= 50, 45, 54, 60)	39.26 ( 33.847 )	34.67 ( 15.191 )	18.12 ( 8.439 )	9.22 ( 4.116 )
Week 16 (N= 49, 48, 49, 52)	40.12 ( 28.610 )	38.09 ( 13.536 )	18.39 ( 7.245 )	10.13 ( 4.515 )
Week 17 (N= 49, 54, 54, 51)	62.34 ( 28.081 )	64.64 ( 24.169 )	29.26 ( 11.659 )	16.79 ( 6.677 )
Week 20 (N= 49, 49, 54, 56)	37.92 ( 14.171 )	48.26 ( 30.691 )	19.31 ( 7.203 )	10.68 ( 3.715 )
Week 24 (N= 41, 43, 47, 43)	41.98 ( 23.087 )	43.81 ( 17.403 )	20.25 ( 10.575 )	11.07 ( 3.918 )

No statistical analyses for this end point

Secondary: Serum KY1005 Concentration Assessed Throughout the Study (Part 2)

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End point title

Serum KY1005 Concentration Assessed Throughout the Study (Part 2)

End point description

This analysis was conducted for Part 2 and includes participants who took at least one dose of KY1005. Only those participants with data available at specified timepoints are reported

End point type

Secondary

End point timeframe

Baseline and at Weeks 24, 25, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Number of subjects analysed	13	34	12	28	12	33	7	35
Units: ug/ml
arithmetic mean (standard deviation)
Week 24 (N= 9, 18, 11, 19, 10, 20, 4, 19)	45.13 ( 15.842 )	36.68 ( 17.544 )	45.00 ( 14.568 )	43.17 ( 19.752 )	19.03 ( 9.612 )	19.48 ( 7.791 )	11.60 ( 1.383 )	11.10 ( 5.240 )
Week 25 (N= 12, 28, 10, 23, 10, 24, 4, 24)	73.54 ( 30.680 )	36.54 ( 20.508 )	71.25 ( 16.294 )	34.71 ( 14.551 )	31.07 ( 16.115 )	17.57 ( 7.504 )	15.90 ( 2.443 )	10.36 ( 5.145 )
Week 28 (N= 13, 23, 11, 21, 10, 24, 3, 23)	51.50 ( 25.454 )	17.59 ( 9.090 )	46.15 ( 15.782 )	25.22 ( 10.235 )	20.12 ( 11.820 )	10.03 ( 4.697 )	9.56 ( 3.485 )	6.66 ( 2.584 )
Week 32 (N= 11, 20, 10, 15, 9, 18, 3, 21)	44.41 ( 11.438 )	8.86 ( 5.074 )	41.50 ( 13.681 )	12.54 ( 5.943 )	20.99 ( 12.614 )	4.57 ( 2.463 )	9.40 ( 1.749 )	3.32 ( 1.588 )
Week 36 (N= 9, 20, 9, 16, 9, 20, 4, 20)	43.11 ( 18.965 )	5.41 ( 3.876 )	51.42 ( 18.946 )	7.80 ( 4.413 )	22.28 ( 18.101 )	2.85 ( 2.275 )	13.38 ( 2.128 )	1.77 ( 1.018 )
Week 40 (N= 9, 20, 9, 18, 8, 23, 5, 20)	45.19 ( 19.921 )	2.42 ( 1.660 )	43.79 ( 15.955 )	4.54 ( 2.929 )	19.09 ( 11.479 )	1.68 ( 1.669 )	10.95 ( 1.350 )	0.96 ( 0.748 )
Week 44 (N= 10, 21, 8, 18, 10, 19, 6, 21)	40.91 ( 12.068 )	1.04 ( 0.908 )	46.98 ( 24.015 )	2.62 ( 2.193 )	16.43 ( 7.302 )	0.82 ( 0.863 )	11.25 ( 2.607 )	0.57 ( 0.554 )
Week 48 (N= 11, 18, 8, 19, 9, 19, 6, 21)	41.43 ( 14.214 )	0.58 ( 0.507 )	43.63 ( 22.188 )	1.40 ( 1.727 )	17.80 ( 9.065 )	0.42 ( 0.483 )	11.12 ( 1.825 )	0.25 ( 0.305 )
Week 52 (N= 10, 20, 10, 17, 7, 20, 5, 19)	38.88 ( 11.526 )	0.56 ( 1.112 )	45.59 ( 22.447 )	0.55 ( 0.573 )	22.60 ( 8.225 )	0.19 ( 0.289 )	12.03 ( 3.775 )	0.11 ( 0.129 )

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)

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End point title

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 1)

End point description

Safety Analysis Part 1:Participants who took at least a dose of study treatment, including placebo up to Week 24. Analysis based on the SAF1 was based on the treatment received, regardless of assigned treatment according to the randomization.

End point type

Secondary

End point timeframe

Baseline through Week 24

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)
Number of subjects analysed	77	78	77	78	78
Units: percentage of participants
number (not applicable)
Percentage of Participants With at Least One TEAE	66.2	66.7	67.5	67.9	60.3
Percentage of Particpants With Any Serious TEAE	2.6	0	1.3	6.4	1.3

No statistical analyses for this end point

Secondary: Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)

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End point title

Percentage of Participants With at Least One Treatment-emergent Adverse Event (TEAE) and Any Serious TEAE (Part 2)

End point description

Safety Analysis Part 2: All re-randomized participants at Week 24 who took at least a dose of study treatment on/or after Week 24. Any analysis based on the SAF2 was based on the treatment at Week 24, regardless of treatment according to the randomization.

End point type

Secondary

End point timeframe

Week 24 through Week 68

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	11	28	12	32	7	34	15
Units: percentage of participants
number (not applicable)
Percentage of Participants With at Least One TEAE	84.6	67.6	63.6	78.6	66.7	87.5	57.1	67.6	66.7
Percentage of Particpants With Any Serious TEAE	7.7	2.9	0	7.1	8.3	0	0	0	0

No statistical analyses for this end point

Secondary: Percentage of Participants With Treatment-emergent ADA (Part 1)

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End point title

Percentage of Participants With Treatment-emergent ADA (Part 1) ^[2]

End point description

The Full Analysis Set (FAS1) for Part 1 included all randomized participants up to Week 24.

End point type

Secondary

End point timeframe

Baseline through Week 24

Notes
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: ADA test is not applicable for Placebo arm.

End point values	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)
Number of subjects analysed	77	76	77	77
Units: percentage of particpants
number (not applicable)
% of Participants With Treatment-emergent ADA	2.6	6.4	13.2	32.1

No statistical analyses for this end point

Secondary: Percentage of Participants With Treatment-emergent ADA (Part 2)

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End point title

Percentage of Participants With Treatment-emergent ADA (Part 2)

End point description

The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24.

End point type

Secondary

End point timeframe

Baseline through Week 68

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)
Number of subjects analysed	13	33	11	26	12	31	7	33
Units: percentage of participants
number (not applicable)
% of Participants With Treatment-emergent ADA	7.7	9.1	9.1	19.2	0	35.5	28.6	42.4

No statistical analyses for this end point

Secondary: Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

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End point title

Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

End point description

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints are reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: score on a scale
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28, 12, 33 , 5, 33, 16)	-29.65 ( 11.278 )	-26.28 ( 13.353 )	-27.60 ( 11.170 )	-18.90 ( 11.932 )	-27.10 ( 12.670 )	-22.45 ( 14.998 )	-25.47 ( 12.209 )	-22.41 ( 12.841 )	-21.47 ( 10.420 )
Week 28 (N= 13, 34, 12, 28, 12, 31 , 7, 34, 14)	-30.51 ( 12.422 )	-26.34 ( 14.353 )	-25.86 ( 13.128 )	-17.29 ( 12.458 )	-26.37 ( 13.067 )	-22.87 ( 15.667 )	-23.79 ( 10.424 )	-21.75 ( 13.106 )	-21.69 ( 11.918 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-29.08 ( 14.544 )	-24.79 ( 15.775 )	-22.99 ( 15.741 )	-15.38 ( 12.620 )	-27.36 ( 13.383 )	-22.94 ( 14.915 )	-24.94 ( 11.245 )	-20.32 ( 14.189 )	-19.60 ( 10.632 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-28.15 ( 15.138 )	-22.78 ( 17.505 )	-22.27 ( 16.368 )	-14.57 ( 13.550 )	-27.51 ( 13.550 )	-22.99 ( 14.978 )	-24.65 ( 10.801 )	-20.09 ( 15.098 )	-20.20 ( 10.436 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-28.54 ( 15.203 )	-22.30 ( 17.908 )	-22.56 ( 14.949 )	-14.81 ( 13.178 )	-27.96 ( 14.444 )	-20.45 ( 16.659 )	-25.51 ( 11.796 )	-20.80 ( 14.343 )	-20.05 ( 10.596 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-28.43 ( 15.061 )	-22.23 ( 17.487 )	-23.07 ( 15.679 )	-14.49 ( 12.877 )	-27.49 ( 14.324 )	-19.76 ( 16.561 )	-22.34 ( 11.070 )	-20.70 ( 14.343 )	-20.43 ( 11.007 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-22.15 ( 14.876 )	-21.82 ( 17.764 )	-22.24 ( 16.312 )	-13.95 ( 13.596 )	-27.72 ( 14.882 )	-18.34 ( 16.959 )	-23.88 ( 12.517 )	-19.74 ( 15.277 )	-19.99 ( 11.292 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 31, 14)	-22.03 ( 14.889 )	-19.59 ( 15.321 )	-22.68 ( 15.418 )	-13.89 ( 13.427 )	-28.08 ( 16.097 )	-17.30 ( 16.752 )	-23.26 ( 11.789 )	-20.81 ( 14.813 )	-20.30 ( 11.526 )

No statistical analyses for this end point

Secondary: Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

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End point title

Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 2)

End point description

Eczema Area and Severity Index-The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD with scores from 0 to 72. Higher scores indicate worse condition. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified timepoints are reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 28, 32, 36, 40, 44, 48 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of change
arithmetic mean (standard deviation)
Week 24 (N= 13, 34, 12, 28, 12, 33 , 5, 33, 16)	-91.71 ( 8.539 )	-81.85 ( 31.624 )	-84.20 ( 16.741 )	-72.72 ( 41.299 )	-90.91 ( 10.585 )	-62.46 ( 63.983 )	-85.81 ( 10.212 )	-76.74 ( 30.922 )	-78.51 ( 28.977 )
Week 28 (N= 13, 34, 12, 28, 12, 31 , 7, 34, 14)	-93.56 ( 8.382 )	-81.47 ( 32.251 )	-79.34 ( 28.091 )	-66.53 ( 43.437 )	-87.78 ( 13.648 )	-74.18 ( 42.104 )	-89.88 ( 6.304 )	-74.54 ( 31.665 )	-76.87 ( 31.377 )
Week 32 (N= 13, 34, 11, 28 12, 32, 7, 32, 15)	-86.08 ( 24.896 )	-76.51 ( 38.401 )	-69.06 ( 38.468 )	-58.78 ( 44.767 )	-91.07 ( 13.744 )	-75.64 ( 41.038 )	-93.76 ( 4.960 )	-68.09 ( 34.850 )	-71.98 ( 33.063 )
Week 36 (N= 13, 33, 10, 28, 12, 32, 7, 32, 15)	-86.56 ( 28.656 )	-69.33 ( 43.838 )	-66.64 ( 39.631 )	-56.24 ( 46.469 )	-91.22 ( 13.203 )	-75.77 ( 40.984 )	-93.0 ( 6.000 )	-67.27 ( 40.162 )	-74.93 ( 32.664 )
Week 40 (N= 13, 31, 11, 28, 11, 32, 7, 31, 15)	-84.74 ( 28.948 )	-65.65 ( 44.932 )	-68.31 ( 38.024 )	-57.39 ( 47.379 )	-90.68 ( 13.737 )	-64.68 ( 64.041 )	-95.55 ( 5.011 )	-70.11 ( 37.802 )	-74.05 ( 32.343 )
Week 44 (N= 13, 32, 11, 28, 12, 32, 7, 31, 14)	-84.46 ( 28.757 )	-66.73 ( 44.328 )	-69.41 ( 38.731 )	-56.30 ( 46.700 )	-90.18 ( 12.912 )	-62.46 ( 63.983 )	-83.57 ( 21.909 )	-69.98 ( 37.145 )	-72.99 ( 33.353 )
Week 48 (N= 13, 32, 10, 28, 12, 30, 7, 30, 14)	-71.66 ( 40.416 )	-65.18 ( 44.327 )	-66.61 ( 39.645 )	-53.59 ( 48.780 )	-90.26 ( 12.961 )	-57.47 ( 65.142 )	-88.02 ( 22.234 )	-66.63 ( 40.889 )	-70.92 ( 33.888 )
Week 52 (N= 13, 31, 11, 28, 11, 29, 7, 31, 14)	-71.22 ( 40.152 )	-61.78 ( 44.406 )	-68.09 ( 37.719 )	-53.58 ( 48.725 )	-89.09 ( 15.625 )	-54.42 ( 65.177 )	86.51 ( 22.331 )	-69.76 ( 38.241 )	-72.04 ( 34.827 )

No statistical analyses for this end point

Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)

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End point title

Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 2)

End point description

The pruritus NRS is a simple assessment tool to report the intensity of their pruritus (itch) ranges from 0 to 10 with 0 being ‘no itch’ and 10 being the ‘worst itch imaginable’. The Full Analysis Set (FAS2) for Part 2 included all re-randomized at Week 24. Only those participants with data available at specified time points are reported.

End point type

Secondary

End point timeframe

Baseline to Weeks 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51 and 52

End point values	250 mg KY1005 Re-Randomized From the 250 mg (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2)	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo (Part 2) Continued From Part 1 Placebo
Number of subjects analysed	13	34	12	28	12	33	7	35	16
Units: percentage of participants
number (not applicable)
Week 24	53.8	41.2	75.0	35.7	58.3	45.5	71.4	45.7	25.0
Week 25	53.8	41.2	66.7	39.3	66.7	39.4	57.1	37.1	31.3
Week 26	53.8	39.2	66.7	32.1	58.3	33.3	71.4	42.9	25.0
Week 27	61.5	35.3	58.3	28.6	58.3	39.4	71.4	37.1	25.0
Week 28	61.5	35.3	66.7	35.7	58.3	42.4	57.1	37.1	25.0
Week 29	69.2	38.2	50.0	25.0	58.3	45.5	57.1	40.0	25.0
Week 30	61.5	44.1	58.3	25.0	66.7	36.4	42.9	42.9	18.8
Week 31	61.5	41.2	58.3	25.0	66.7	36.4	42.9	40.0	18.8
Week 32	61.5	47.1	50.0	25.0	75.0	42.4	71.4	40.0	18.8
Week 33	61.5	47.1	58.3	28.6	58.3	42.4	71.4	40.0	18.8
Week 34	61.5	41.2	75.0	21.4	75.0	30.3	42.9	37.1	25.0
Week 35	61.5	41.2	66.7	21.4	66.7	39.4	71.4	34.3	25.0
Week 36	61.5	38.2	58.3	21.4	66.7	42.4	71.4	40.0	25.0
Week 37	53.8	41.2	50.0	28.6	66.7	42.4	71.4	37.1	18.8
Week 38	53.8	35.3	50.0	25.0	58.3	42.4	71.4	31.4	18.8
Week 39	53.8	41.2	50.0	25.0	58.3	39.4	71.4	31.4	25.0
Week 40	53.8	38.2	33.3	25.0	58.3	36.4	28.6	31.4	25.0
Week 41	61.5	35.3	41.7	28.6	66.7	39.4	57.1	34.3	31.3
Week 42	53.8	38.2	50.0	28.6	66.7	36.4	42.9	31.4	25.0
Week 43	53.8	35.3	50.0	28.6	58.3	36.4	42.9	34.3	31.3
Week 44	61.5	38.2	41.7	21.4	75.0	39.4	42.9	37.1	25.0
Week 45	61.5	41.2	41.7	21.4	75.0	36.4	42.9	40.0	31.3
Week 46	53.8	44.1	50.0	28.6	50.0	27.3	42.9	37.1	31.3
Week 47	46.2	38.2	33.3	28.6	58.3	30.3	42.9	45.7	25.0
Week 48	38.5	35.3	41.7	28.6	66.7	27.3	57.1	37.1	25.0
Week 49	38.5	41.2	50.0	35.7	66.7	30.3	57.1	40.0	25.0
Week 50	38.5	35.3	50.0	32.1	66.7	24.2	57.1	37.1	25.0
Week 51	30.8	32.4	41.7	28.6	58.3	27.3	42.9	34.3	25.0
Week 52	46.2	29.4	41.7	25.0	66.7	27.3	57.1	40.0	25.0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

The Adverse events were reported in the timeframe for Part 1 from Baseline to Week 24 + 16 weeks follow up period and for patients enrolled in Part 2 from Week 24 to Week 52 plus 16 weeks follow-up period.

Adverse event reporting additional description

The total number of patients in AEs reporting is different for Part 1 and Part 2.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

26.1

Reporting group title

250 mg (500 mg LD) KY1005 (Part 1)

Reporting group description

Reporting group title

250 mg (no LD) KY1005 (Part 1)

Reporting group description

Reporting group title

125 mg KY1005 (Part 1)

Reporting group description

Reporting group title

62.5 mg KY1005 (Part 1)

Reporting group description

Reporting group title

Placebo (Part 1)

Reporting group description

Reporting group title

250 mg KY1005 Re-Randomized From the (LD) Arm (Part 2)

Reporting group description

Reporting group title

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

Reporting group description

Reporting group title

250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)

Reporting group description

Reporting group title

Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)

Reporting group description

Reporting group title

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Reporting group description

Reporting group title

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

Reporting group description

Reporting group title

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2

Reporting group description

Reporting group title

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Reporting group description

Reporting group title

Placebo Continued From Part 1 Placebo (Part 2)

Reporting group description

250 mg (500 mg LD) KY1005 (Part 1)

250 mg (no LD) KY1005 (Part 1)

125 mg KY1005 (Part 1)

62.5 mg KY1005 (Part 1)

Placebo (Part 1)

250 mg KY1005 Re-Randomized From the (LD) Arm (Part 2)

Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)

250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)

Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)

125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)

Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)

62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2

Placebo Re-randomized From the 62.5 mg Arm (Part 2)

Placebo Continued From Part 1 Placebo (Part 2)

Total subjects affected by serious adverse events

subjects affected / exposed

2 / 77 (2.60%)

0 / 78 (0.00%)

1 / 77 (1.30%)

5 / 78 (6.41%)

1 / 78 (1.28%)

1 / 13 (7.69%)

1 / 34 (2.94%)

0 / 11 (0.00%)

2 / 28 (7.14%)

1 / 12 (8.33%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

number of deaths (all causes)

number of deaths resulting from adverse events

Injury, poisoning and procedural complications

Forearm fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

1 / 78 (1.28%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ankle fracture

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

1 / 12 (8.33%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tendon rupture

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

1 / 34 (2.94%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Atrial fibrillation

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

1 / 78 (1.28%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Supraventricular tachycardia

subjects affected / exposed

1 / 77 (1.30%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

Tension headache

subjects affected / exposed

1 / 77 (1.30%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Haemorrhoidal haemorrhage

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

1 / 78 (1.28%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Umbilical hernia

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

1 / 13 (7.69%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Dermatitis bullous

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

1 / 77 (1.30%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

Alcohol withdrawal syndrome

subjects affected / exposed

1 / 77 (1.30%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Osteoarthritis

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

1 / 78 (1.28%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rotator cuff syndrome

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

1 / 28 (3.57%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal osteoarthritis

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

1 / 28 (3.57%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Appendicitis

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

1 / 78 (1.28%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pharyngitis

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

1 / 78 (1.28%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Metabolic acidosis

subjects affected / exposed

1 / 77 (1.30%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

0 / 28 (0.00%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Abnormal loss of weight

subjects affected / exposed

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 77 (0.00%)

0 / 78 (0.00%)

0 / 13 (0.00%)

0 / 34 (0.00%)

0 / 11 (0.00%)

1 / 28 (3.57%)

0 / 12 (0.00%)

0 / 32 (0.00%)

0 / 7 (0.00%)

0 / 34 (0.00%)

0 / 15 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	250 mg (500 mg LD) KY1005 (Part 1)	250 mg (no LD) KY1005 (Part 1)	125 mg KY1005 (Part 1)	62.5 mg KY1005 (Part 1)	Placebo (Part 1)	250 mg KY1005 Re-Randomized From the (LD) Arm (Part 2)	Placebo Re-Randomized From the 250 mg (LD) Arm (Part 2)	250mg KY1005 Re-randomized From the 250 mg (no LD) Arm(Part 2)	Placebo Re-Randomized From the 250 mg (no LD) Arm (Part 2)	125 mg KY1005 Re-randomized From the 125 mg Arm (Part 2)	Placebo Re-randomized From the 125 mg KY1005 Arm (Part 2)	62.5 mg Re-Randomized From the 62.5 mg KY1005 Arm (Part 2	Placebo Re-randomized From the 62.5 mg Arm (Part 2)	Placebo Continued From Part 1 Placebo (Part 2)
Total subjects affected by non serious adverse events
subjects affected / exposed	42 / 77 (54.55%)	39 / 78 (50.00%)	39 / 77 (50.65%)	41 / 78 (52.56%)	41 / 78 (52.56%)	11 / 13 (84.62%)	21 / 34 (61.76%)	7 / 11 (63.64%)	19 / 28 (67.86%)	8 / 12 (66.67%)	27 / 32 (84.38%)	4 / 7 (57.14%)	21 / 34 (61.76%)	10 / 15 (66.67%)
Vascular disorders
Hypertension
subjects affected / exposed	2 / 77 (2.60%)	1 / 78 (1.28%)	1 / 77 (1.30%)	4 / 78 (5.13%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	1	1	4	0	0	1	0	0	0	2	0	0	0
General disorders and administration site conditions
Influenza like illness
subjects affected / exposed	1 / 77 (1.30%)	1 / 78 (1.28%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	1	0	0	0	0	1	1	0	0	0	0	0	0
Fatigue
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 78 (0.00%)	1 / 13 (7.69%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	3 / 34 (8.82%)	0 / 15 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	2	0	3	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Reproductive system and breast disorders
Dysmenorrhoea
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	1 / 78 (1.28%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	2 / 34 (5.88%)	0 / 15 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	2	0
Heavy menstrual bleeding
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
subjects affected / exposed	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	1 / 28 (3.57%)	0 / 12 (0.00%)	1 / 32 (3.13%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	1	0	0	0	0	0	0	0	1	0	1	0	0	1
Oropharyngeal pain
subjects affected / exposed	2 / 77 (2.60%)	0 / 78 (0.00%)	2 / 77 (2.60%)	1 / 78 (1.28%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	0	2	1	0	0	1	0	0	1	0	0	0	0
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	4 / 77 (5.19%)	2 / 78 (2.56%)	0 / 77 (0.00%)	2 / 78 (2.56%)	2 / 78 (2.56%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	1 / 32 (3.13%)	1 / 7 (14.29%)	2 / 34 (5.88%)	0 / 15 (0.00%)
occurrences all number	5	2	0	2	2	0	0	0	0	1	1	1	2	0
Alanine aminotransferase increased
subjects affected / exposed	2 / 77 (2.60%)	2 / 78 (2.56%)	1 / 77 (1.30%)	1 / 78 (1.28%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	3	2	1	1	1	0	0	0	0	1	0	0	0	0
Aspartate aminotransferase increased
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	1 / 78 (1.28%)	1 / 78 (1.28%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	1 / 34 (2.94%)	0 / 15 (0.00%)
occurrences all number	0	0	0	1	1	0	1	0	0	1	0	0	1	0
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 77 (0.00%)	1 / 78 (1.28%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	1	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Accidental overdose
subjects affected / exposed	1 / 77 (1.30%)	3 / 78 (3.85%)	1 / 77 (1.30%)	2 / 78 (2.56%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	1 / 34 (2.94%)	1 / 15 (6.67%)
occurrences all number	1	3	1	2	1	0	0	0	0	0	2	0	1	1
Muscle strain
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	1 / 7 (14.29%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Nervous system disorders
Headache
subjects affected / exposed	4 / 77 (5.19%)	4 / 78 (5.13%)	4 / 77 (5.19%)	7 / 78 (8.97%)	2 / 78 (2.56%)	2 / 13 (15.38%)	1 / 34 (2.94%)	1 / 11 (9.09%)	1 / 28 (3.57%)	2 / 12 (16.67%)	2 / 32 (6.25%)	0 / 7 (0.00%)	1 / 34 (2.94%)	1 / 15 (6.67%)
occurrences all number	4	4	4	7	2	2	1	1	1	2	2	0	1	1
Dizziness
subjects affected / exposed	2 / 77 (2.60%)	0 / 78 (0.00%)	2 / 77 (2.60%)	0 / 78 (0.00%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	2	0	3	0	1	0	0	0	0	1	0	0	0	1
Hypoaesthesia
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Tension headache
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Gastrointestinal disorders
Abdominal pain upper
subjects affected / exposed	1 / 77 (1.30%)	2 / 78 (2.56%)	1 / 77 (1.30%)	2 / 78 (2.56%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	2 / 28 (7.14%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	1	2	1	2	1	0	0	0	2	0	0	0	0	1
Food poisoning
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	1 / 78 (1.28%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	1 / 34 (2.94%)	0 / 15 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0	1	0
Abdominal pain
subjects affected / exposed	1 / 77 (1.30%)	0 / 78 (0.00%)	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 78 (0.00%)	1 / 13 (7.69%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	0	1	0	0	1	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	9 / 77 (11.69%)	16 / 78 (20.51%)	15 / 77 (19.48%)	13 / 78 (16.67%)	30 / 78 (38.46%)	6 / 13 (46.15%)	14 / 34 (41.18%)	3 / 11 (27.27%)	15 / 28 (53.57%)	1 / 12 (8.33%)	14 / 32 (43.75%)	1 / 7 (14.29%)	12 / 34 (35.29%)	4 / 15 (26.67%)
occurrences all number	10	22	19	14	43	8	21	4	19	1	17	1	13	5
Dermatitis acneiform
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	1 / 13 (7.69%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	1 / 13 (7.69%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Rosacea
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	1 / 77 (1.30%)	0 / 78 (0.00%)	1 / 77 (1.30%)	1 / 78 (1.28%)	2 / 78 (2.56%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	1 / 7 (14.29%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	1	0	1	1	1	0	0	0	0	0	2	2	0	0
Spinal pain
subjects affected / exposed	2 / 77 (2.60%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	2 / 15 (13.33%)
occurrences all number	2	0	0	0	0	0	1	0	0	0	0	0	0	2
Muscle spasms
subjects affected / exposed	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 77 (0.00%)	1 / 78 (1.28%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	0	0	0	1
Periostitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Infections and infestations
Nasopharyngitis
subjects affected / exposed	14 / 77 (18.18%)	6 / 78 (7.69%)	9 / 77 (11.69%)	5 / 78 (6.41%)	7 / 78 (8.97%)	2 / 13 (15.38%)	4 / 34 (11.76%)	1 / 11 (9.09%)	2 / 28 (7.14%)	0 / 12 (0.00%)	5 / 32 (15.63%)	0 / 7 (0.00%)	3 / 34 (8.82%)	2 / 15 (13.33%)
occurrences all number	19	8	12	5	10	2	4	1	2	0	6	0	4	3
COVID-19
subjects affected / exposed	6 / 77 (7.79%)	7 / 78 (8.97%)	7 / 77 (9.09%)	4 / 78 (5.13%)	5 / 78 (6.41%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	1 / 28 (3.57%)	1 / 12 (8.33%)	1 / 32 (3.13%)	0 / 7 (0.00%)	1 / 34 (2.94%)	0 / 15 (0.00%)
occurrences all number	6	7	7	4	5	0	0	0	1	1	1	0	1	0
Upper respiratory tract infection
subjects affected / exposed	2 / 77 (2.60%)	2 / 78 (2.56%)	4 / 77 (5.19%)	5 / 78 (6.41%)	5 / 78 (6.41%)	0 / 13 (0.00%)	2 / 34 (5.88%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	1 / 32 (3.13%)	0 / 7 (0.00%)	3 / 34 (8.82%)	1 / 15 (6.67%)
occurrences all number	2	3	4	6	5	0	3	0	0	0	1	0	3	1
Viral upper respiratory tract infection
subjects affected / exposed	2 / 77 (2.60%)	3 / 78 (3.85%)	2 / 77 (2.60%)	4 / 78 (5.13%)	2 / 78 (2.56%)	0 / 13 (0.00%)	0 / 34 (0.00%)	4 / 11 (36.36%)	0 / 28 (0.00%)	1 / 12 (8.33%)	1 / 32 (3.13%)	0 / 7 (0.00%)	0 / 34 (0.00%)	2 / 15 (13.33%)
occurrences all number	2	3	3	7	3	0	0	4	0	1	1	0	0	2
Oral herpes
subjects affected / exposed	2 / 77 (2.60%)	1 / 78 (1.28%)	1 / 77 (1.30%)	1 / 78 (1.28%)	1 / 78 (1.28%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	1 / 28 (3.57%)	1 / 12 (8.33%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	1	1	2	1	0	1	0	1	1	2	0	0	0
Folliculitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	1 / 32 (3.13%)	0 / 7 (0.00%)	1 / 34 (2.94%)	1 / 15 (6.67%)
occurrences all number	0	0	3	0	0	0	1	0	0	0	1	0	1	1
Rhinitis
subjects affected / exposed	2 / 77 (2.60%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 78 (1.28%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	0	0	0	1	0	1	0	0	0	2	0	0	0
Pharyngitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 77 (1.30%)	1 / 78 (1.28%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	2 / 28 (7.14%)	1 / 12 (8.33%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	1	1	0	0	1	0	2	1	3	0	0	0
Dermatitis infected
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	4 / 34 (11.76%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	4	0	0	0	0	0	0	0
Influenza
subjects affected / exposed	2 / 77 (2.60%)	1 / 78 (1.28%)	1 / 77 (1.30%)	1 / 78 (1.28%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	1	1	1	0	0	1	0	0	0	2	0	0	0
Sinusitis
subjects affected / exposed	1 / 77 (1.30%)	1 / 78 (1.28%)	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	1	1	0	0	0	0	0	0	1	2	0	0	0
Tonsillitis
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 77 (1.30%)	1 / 78 (1.28%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	1 / 32 (3.13%)	0 / 7 (0.00%)	1 / 34 (2.94%)	1 / 15 (6.67%)
occurrences all number	0	0	1	1	1	0	0	1	0	0	1	0	1	1
Cystitis
subjects affected / exposed	0 / 77 (0.00%)	1 / 78 (1.28%)	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 78 (1.28%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	1 / 7 (14.29%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	1	0	0
Postoperative wound infection
subjects affected / exposed	2 / 77 (2.60%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	2	0	0	0	0	0	0	1	0	0	0	0	0	0
Herpes simplex
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 77 (0.00%)	1 / 78 (1.28%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	1 / 34 (2.94%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	1 / 7 (14.29%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	3	0	0	0	0	1	1	0	0	0	1	0	0
Bronchitis viral
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	1 / 77 (1.30%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	1 / 11 (9.09%)	0 / 28 (0.00%)	0 / 12 (0.00%)	1 / 32 (3.13%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	1	0	0	0
Otitis media
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	1 / 28 (3.57%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	1 / 15 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	1
Fungal skin infection
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	1 / 12 (8.33%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Pyuria
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	1 / 13 (7.69%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	0 / 32 (0.00%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Hypercholesterolaemia
subjects affected / exposed	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 77 (0.00%)	0 / 78 (0.00%)	0 / 78 (0.00%)	0 / 13 (0.00%)	0 / 34 (0.00%)	0 / 11 (0.00%)	0 / 28 (0.00%)	0 / 12 (0.00%)	2 / 32 (6.25%)	0 / 7 (0.00%)	0 / 34 (0.00%)	0 / 15 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0

More information

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Were there any global substantial amendments to the protocol? Yes

14 Sep 2021

Amended Protocol 2 Key changes included various clarifications to the text and updates to: • management of patients who continued to respond to IMP at Day 365 (Week 52), and enter safety follow-up instead of LTE; • add definition of loss of clinical response; • impact of KY1005 on vaccination response in AD has not been tested to date; • primary analysis timepoint at Day 169 (W24) visit; • randomization stratification by IGA response at W24; • frequency of IDMC meetings and data reviewed; • definition of women of non-child bearing potential; • participant contraceptive requirements; • abnormal pregnancy outcomes; • report of symptomatic overdose as an AESI within 24 hours of learning of the event; • collection of prior systemic therapies for any indication with reason for discontinuation; • frequency of physical examinations; • definition of body surface area; • definition of mild, moderate, and severe AEs and TEAEs; • liver function severe laboratory abnormalities requiring permanent discontinuation of IMP; • intended use of data collected regarding the impact of COVID-19 or other pandemics; • add AE and rescue therapy stopping criteria; and • specify sample processing to the Bioanalytical laboratory.

14 Dec 2021

Amended Protocol 4 • To fulfil requirement from PMDA, Japan, a clarification was added regarding Hepatitis serology testing. • Hypersensitivity to KY1005 including excipients added as an exclusion criterion was added. • Any prior receipt of any anti-OX40 or anti-OX40L, including KY1005 as an exclusion criterion was added.

18 Jan 2022

Amended Protocol 5 • To fulfil requirement from the MHRA, UK, country-specific clarification was added to an inclusion criterion. • Clarification was added that LTE is a separate study to KY1005-CT05 (DRI17366). • Specific exclusionary levels of hepatic (aspartate aminotransferase, alanine aminotransferase, and total bilirubin, including total bilirubin levels for subjects with Gilbert’s syndrome) and renal function test were added. • Hypersensitivity to the components of the placebo formulation as an exclusion criterion was added. • Rationale for inclusion of 62.5 mg dose level was clarified in this dose ranging study, and additional safety considerations were outlined for all 4 dose levels. • Clarification was added that the biopsy was done only at selected sites on those patients who agree to enroll into the skin biopsy sub-study, and the biopsy was not conducted in patients if there was a contraindication to the procedure in the Investigator’s opinion. • Other clarifications were made concerning the biopsy, dose level discontinuation, definition of women of childbearing potential, Common Terminology Criteria for Adverse Events grading scale, responsibilities in the event of blind break, monitoring of AEs by Investigators, and re-challenge. • Addition of final safety follow-up visit at Day 477 (Week 68) as requested to take into consideration 5 elimination half-lives of IMP. Anti-drug antibody collection from Day 449 (Week 64) was postponed to Day 477 (Week 68) to match the last visit.

01 Mar 2022

Amended Protocol 8 • To fulfil requirements from the German authorities PEI and EC of the State of Berlin (Ethik-Kommission des Landes Berlin) with global impact, requirements from Czech Health Authorities (STÁTNÍ ÚSTAV PRO KONTROLU LÉČIV), and requirements from Hungarian Emberi Erőforrások Minisztériuma, (Ministry of Human Capacities). • Interim analysis was added to obtain early information for planning the Phase 3 program and to support the timely analysis of data from participants who completed the Day 113 (Week 16) assessments. No study conduct was modified based on interim analysis results. • Also, the inclusion of an interim analysis, modification in the biopsy requirements, and overall clarifications.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

Primary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 16 (Part 1)

Secondary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)

Secondary: Percentage Change in EASI (Eczema Area and Severity Index) From Baseline to Week 24 (Part 1)

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) at Week 16 and Week 24 (Part 1)

Secondary: Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)

Secondary: Percentage of Participants With a Response of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline ≥ 2 Points (Part 1)

Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)

Secondary: Percentage of Participants With Improvement (Reduction) of Weekly Average of Pruritus NRS (Numerical Rating Scale) ≥ 4 With a Baseline Pruritus of ≥ 4 From Baseline (Part 1)

Secondary: Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Secondary: Absolute Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Secondary: Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Secondary: Percentage Change From Baseline in EASI (Eczema Area and Severity Index) (Part 1)

Secondary: Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)

Secondary: Percentage of Participants With at Least a 50% Reduction From Baseline in EASI (EASI 50) (Part 1)

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)

Secondary: Percentage of Participants With at Least a 75% Reduction From Baseline in EASI (EASI 75) (Part 1)

Secondary: Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)

Secondary: Percentage of Participants With at Least a 90% Reduction From Baseline in EASI (EASI 90) (Part 1)

Secondary: Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)

Secondary: Percentage of Participants With a 100% Reduction From Baseline in EASI (EASI 100) (Part 1)

Secondary: Change in IGA (Investigator Global Assessment) From Baseline to Week 24 (Part 1)

Secondary: Change in IGA (Investigator Global Assessment) From Baseline to Week 24 (Part 1)

Secondary: Change in IGA (Investigator Global Assessment) From Baseline (Part 2)

Secondary: Change in IGA (Investigator Global Assessment) From Baseline (Part 2)

Secondary: Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)

Secondary: Percentage of Participants With a Score of IGA (Investigator Global Assessment) 0 or 1 and a Reduction From Baseline of ≥ 2 Points (Part 1)

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

Secondary: Absolute Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 1)

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

Secondary: Percentage Change in SCORAD (SCORing Atopic Dermatitis) Index From Baseline (Part 2)

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

Secondary: Absolute Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 1)

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

Secondary: Percentage Change in Affected Body Surface Area (BSA) From Baseline (Part 2)

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

Secondary: Absolute Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 1)

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

Secondary: Percentage Change in Patient Oriented Eczema Measure (POEM) From Baseline (Part 2)

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

Secondary: Absolute Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 1)

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

Secondary: Percentage Change in Dermatology Life Quality Index (DLQI) From Baseline (Part 2)

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

Secondary: Absolute Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 1)

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

Secondary: Percentage Change in Atopic Dermatitis Control Tool (ADCT) From Baseline (Part 2)

Secondary: Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

Secondary: Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 1)

Secondary: Absolute Change in Hospital Anxiety and Depression Scale (HADS) From Baseline (Part 2)