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Clinical Trial Results:
Phase 1/2A, randomized, placebo-controlled, single-ascending dose (Part A, participant- and investigator-blind) and repeated-dose (Part B, participant-, investigator-, and sponsor-blind) study to investigate the safety, pharmacokinetics, and efficacy of UCB9741 in healthy study participants (Part A) and in study participants with moderate-to-severe atopic dermatitis (Part B)

Summary
EudraCT number	2020-003639-41
Trial protocol	GB NL BG DE ES BE
Global end of trial date	06 Jun 2024

Results information
Results version number	v1(current)
This version publication date	21 Jun 2025
First version publication date	21 Jun 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

UP0089

ISRCTN number

US NCT number

NCT04643457

WHO universal trial number (UTN)

Sponsor organisation name

UCB Biopharma SRL

Sponsor organisation address

Allée de la Recherche 60, Brussels, Belgium, 1070

Public contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.com

Scientific contact

Clin Trial Reg & Results Disclosure, UCB BIOSCIENCES GmbH, clinicaltrials@ucb.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

18 Jul 2024

Is this the analysis of the primary completion data?

Yes

Primary completion date

23 Apr 2024

Global end of trial reached?

Yes

Global end of trial date

06 Jun 2024

Was the trial ended prematurely?

Main objective of the trial

-Investigation of safety and tolerability of single-ascending doses of UCB9741 administered by intravenous (iv) infusion or subcutaneous (sc) injection to healthy study participants -Investigation of safety and tolerability of UCB9741 following repeat-dosing at a single dose level in study participants with atopic dermatitis (AtD) -Investigation of a primary clinical outcome in study participants with AtD after administration of UCB9741 by iv infusion

Protection of trial subjects

During the conduct of the study all participants were closely monitored.

Background therapy

Part A The following concomitant medications were permitted during Part A of the study: • Analgesics, such as paracetamol (acetaminophen), with or without caffeine, with a maximal dose of 4 gram per day (g/day) and 10g/14 days • Contraceptives (oral, implant, or intrauterine devices) Part B The following concomitant medications were permitted during Part B of the study: • Mild topical corticosteroids (TCS), under the direction of the investigator, were permitted for rescue use to treat flares occurring during the study period once a randomized participant reached 2 weeks after first investigational medicinal product (IMP) administration. Such use of mild TCS was discontinued if the investigator and study participant agreed that it was no longer clinically required. Nevertheless, the study participant continued to receive IMP and complete the study as planned. Participants were not randomized if any TCS was used during the 2 weeks prior to randomization. • Non-pharmacologically-active topical interventions (unguents or creams). Skin emollients/moisturizers, when applied, was used at a stable dose and frequency for 7 days prior to the Baseline Visit. • Analgesics, such as paracetamol (acetaminophen), with or without caffeine, with a maximal dose of 4g/day and 10g/14 days • Intranasal corticosteroids for seasonal rhinitis or inhaled bronchodilators and/or inhaled low dose corticosteroids in participants with mild asthma • Contraceptives (oral, implants, or intrauterine devices) If a coronavirus disease 2019 (COVID-19) or influenza vaccine dose was administered during study participation, full details were recorded in the concomitant medication electronic Case Report form (eCRF) page. The specific name of the vaccine and the exact date of administration was recorded.

Evidence for comparator

Not applicable

Actual start date of recruitment

27 Nov 2020

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

United Kingdom: 73

Country: Number of subjects enrolled

Bulgaria: 20

Country: Number of subjects enrolled

Germany: 6

Country: Number of subjects enrolled

Netherlands: 7

Worldwide total number of subjects

106

EEA total number of subjects

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)

106

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study started to enroll participants in November 2020 and concluded in June 2024.

Screening details

The Participant Flow refers to the All Study Participants Set. A total of 107 participants were randomized and enrolled in this study. Out of them, 106 participants have received any treatment. One participant from Part B: UCB9741 Dose 6 discontinued before taking any treatment.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Part A: Placebo

Arm description

Healthy participants received placebo (matching to UCB9741) as a single intravenous (iv) or subcutaneous (sc) administration within each cohort of Part A on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with placebo iv or sc and assessed for safety at least 24 hours in advance and then rest of the cohort follows. Pooled data of placebo (matching to UCB9741) is reported.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Infusion

Routes of administration

Intravenous use, Subcutaneous use

Dosage and administration details

Healthy participants received placebo (matching to UCB9741) within each cohort of Part A on Day 1.

Part A: UCB9741 Dose 1

Arm description

Healthy participants received UCB9741 Dose 1 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 1 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 1 on Day 1.

Part A: UCB9741 Dose 2

Arm description

Healthy participants received UCB9741 Dose 2 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 2 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 2 on Day 1.

Part A: UCB9741 Dose 3

Arm description

Healthy participants received UCB9741 Dose 3 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 3 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 3 on Day 1.

Part A: UCB9741 Dose 4

Arm description

Healthy participants received UCB9741 Dose 4 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 4 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 4 on Day 1.

Part A: UCB9741 Dose 5

Arm description

Healthy participants received UCB9741 Dose 5 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 5 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 5 on Day 1.

Part A: UCB9741 Dose 6

Arm description

Healthy participants received UCB9741 Dose 6 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 6 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 6 on Day 1.

Part A: UCB9741 Dose 7

Arm description

Healthy participants received UCB9741 Dose 7 as a single administration on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with UCB9741 Dose 7 and assessed for safety at least 24 hours in advance and then rest of the cohort follows.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Healthy participants received UCB9741 Dose 7 on Day 1.

Part B: Placebo

Arm description

Participants with moderate-to-severe atopic dermatitis received placebo (matched to UCB9741). Participant assigned were dosed in a sentinel dosing strategy i.e. after the eighth participant received their first dose, dosing of any subsequent participants was held until the eighth participant received their third dose of study medication and assessed for safety at least 48 hours in advance and then dosing in rest of the participants followed.

Arm type

Placebo

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Participants with moderate-to-severe atopic dermatitis received placebo (matched to UCB9741) at repeated interval.

Part B: UCB9741 Dose 6

Arm description

Participants with moderate-to-severe atopic dermatitis received UCB9741 Dose 6. Participant assigned were dosed in a sentinel dosing strategy i.e. after the eighth participant received their first dose, dosing of any subsequent participants was held until the eighth participant received their third dose of study medication and assessed for safety at least 48 hours in advance and then dosing in rest of the participants followed.

Arm type

Experimental

Investigational medicinal product name

UCB9741

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for injection/infusion

Routes of administration

Not mentioned

Dosage and administration details

Participants with moderate-to-severe atopic dermatitis received UCB9741 Dose 6 at repeated interval.

Number of subjects in period 1	Part A: Placebo	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7	Part B: Placebo	Part B: UCB9741 Dose 6
Started	16	6	6	6	6	7	6	6	14	33
Part A: Placebo iv	11 ^[1]	0 ^[2]	0 ^[3]	0 ^[4]	0 ^[5]	0 ^[6]	0 ^[7]	0 ^[8]	0 ^[9]	0 ^[10]
Part A: Placebo sc	5 ^[11]	0 ^[12]	0 ^[13]	0 ^[14]	0 ^[15]	0 ^[16]	0 ^[17]	0 ^[18]	0 ^[19]	0 ^[20]
Completed	16	6	6	6	6	7	6	6	13	30
Not completed	0	0	0	0	0	0	0	0	1	3
Adverse event, non-fatal	-	-	-	-	-	-	-	-	1	2
Consent Withdrawn	-	-	-	-	-	-	-	-	-	1

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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[6] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[7] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[8] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[9] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[10] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[11] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[12] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[13] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[14] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[15] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[16] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[17] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[18] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[19] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.
[20] - 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: 11 participants received Placebo iv and 5 participants received Placebo sc.

Baseline characteristics

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Reporting group title

Part A: Placebo

Reporting group description

Reporting group title

Part A: UCB9741 Dose 1

Reporting group description

Reporting group title

Part A: UCB9741 Dose 2

Reporting group description

Reporting group title

Part A: UCB9741 Dose 3

Reporting group description

Reporting group title

Part A: UCB9741 Dose 4

Reporting group description

Reporting group title

Part A: UCB9741 Dose 5

Reporting group description

Reporting group title

Part A: UCB9741 Dose 6

Reporting group description

Reporting group title

Part A: UCB9741 Dose 7

Reporting group description

Reporting group title

Part B: Placebo

Reporting group description

Reporting group title

Part B: UCB9741 Dose 6

Reporting group description

Reporting group values	Part A: Placebo	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7	Part B: Placebo	Part B: UCB9741 Dose 6	Total
Number of subjects	16	6	6	6	6	7	6	6	14	33	106
Age Categorical
Units: participants
18 - <65 years	16	6	6	6	6	7	6	6	14	33	106
65 - <85 years	0	0	0	0	0	0	0	0	0	0	0
>=85 years	0	0	0	0	0	0	0	0	0	0	0
Age Continuous
Units: years
arithmetic mean (standard deviation)	32.7 ( 11.0 )	23.2 ( 5.2 )	34.0 ( 9.8 )	29.0 ( 8.2 )	26.2 ( 8.5 )	27.4 ( 10.5 )	35.5 ( 14.1 )	39.8 ( 13.7 )	39.2 ( 15.4 )	36.1 ( 10.7 )	-
Sex: Female, Male
Units: participants
Female	7	4	2	3	2	2	3	3	6	12	44
Male	9	2	4	3	4	5	3	3	8	21	62

End points

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Reporting group title

Part A: Placebo

Reporting group description

Reporting group title

Part A: UCB9741 Dose 1

Reporting group description

Reporting group title

Part A: UCB9741 Dose 2

Reporting group description

Reporting group title

Part A: UCB9741 Dose 3

Reporting group description

Reporting group title

Part A: UCB9741 Dose 4

Reporting group description

Reporting group title

Part A: UCB9741 Dose 5

Reporting group description

Reporting group title

Part A: UCB9741 Dose 6

Reporting group description

Reporting group title

Part A: UCB9741 Dose 7

Reporting group description

Reporting group title

Part B: Placebo

Reporting group description

Reporting group title

Part B: UCB9741 Dose 6

Reporting group description

Subject analysis set title

Part A: Placebo iv

Subject analysis set type

Safety analysis

Subject analysis set description

Healthy participants received placebo (matching to UCB9741) as a single intravenous (iv) administration within each cohort of Part A on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with placebo iv and assessed for safety at least 24 hours in advance and then rest of the cohort follows. Pooled data of placebo (matching to UCB9741) is reported.

Subject analysis set title

Part A: Placebo sc

Subject analysis set type

Safety analysis

Subject analysis set description

Healthy participants received placebo (matching to UCB9741) as a single subcutaneous (sc) administration within each cohort of Part A on Day 1. Participant assigned were dosed in a sentinel dosing strategy i.e. one participant was dosed with placebo sc and assessed for safety at least 24 hours in advance and then rest of the cohort follows. Pooled data of placebo (matching to UCB9741) is reported.

Primary: Percentage of participants with treatment-emergent adverse events (TEAEs) during Part A

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End point title

Percentage of participants with treatment-emergent adverse events (TEAEs) during Part A ^[1] ^[2]

End point description

An AE was any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. SS included all study participants who received at least 1 dose of IMP. Study participants were included according to the actual treatment they received.

End point type

Primary

End point timeframe

From Baseline up to the End of Study Visit (Week 12) during Part A

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
[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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7	Part A: Placebo iv	Part A: Placebo sc
Number of subjects analysed	6	6	6	6	7	6	6	11	5
Units: percentage of participants
number (not applicable)	66.7	50.0	66.7	66.7	85.7	83.3	66.7	54.5	80.0

No statistical analyses for this end point

Primary: Percentage of Participants with treatment-emergent serious adverse events (TESAEs) during Part A

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End point title

Percentage of Participants with treatment-emergent serious adverse events (TESAEs) during Part A ^[3] ^[4]

End point description

A TEAE was defined as any AE with a start date/time on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above SS included all study participants who received at least 1 dose of IMP. Study participants were included according to the actual treatment they received.

End point type

Primary

End point timeframe

From Baseline up to the End of Study Visit (Week 12) during Part A

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
[4] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7	Part A: Placebo iv	Part A: Placebo sc
Number of subjects analysed	6	6	6	6	7	6	6	11	5
Units: percentage of participants
number (not applicable)	0	0	0	0	14.3	0	0	0	0

No statistical analyses for this end point

Primary: Percentage of Participants with TEAEs during Part B

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End point title

Percentage of Participants with TEAEs during Part B ^[5] ^[6]

End point description

An AE was any untoward medical occurrence in a patient or clinical study participant temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. Safety set included all study participants who received at least 1 dose of IMP. Study participants were included according to the actual treatment they received.

End point type

Primary

End point timeframe

From Baseline up to the End of Study Visit (Week 18) during Part B

Notes
[5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
[6] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint.

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percentage of participants
number (not applicable)	50.0	72.7

No statistical analyses for this end point

Primary: Percentage of Participants with TESAEs during Part B

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End point title

Percentage of Participants with TESAEs during Part B ^[7] ^[8]

End point description

A TEAE was defined as any AE with a start date/time on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsens in intensity following exposure to the treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence that at any dose: Results in death Is life-threatening Requires inpatient hospitalisation or prolongation of existing hospitalisation Results in persistent or significant disability/incapacity, or Is a congenital anomaly/birth defect Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above. Safety set included all study participants who received at least 1 dose of IMP. Study participants were included according to the actual treatment they received.

End point type

Primary

End point timeframe

From Baseline up to the End of Study Visit (Week 18) during Part B

Notes
[7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
[8] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint.

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percentage of participants
number (not applicable)	0	3.0

No statistical analyses for this end point

Primary: Percentage of Participants with ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B

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End point title

Percentage of Participants with ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B ^[9] ^[10]

End point description

The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities. The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification. The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of atopic dermatitis. A study participant was classified as an EASI75 responder if the EASI score at Week 12 had improved by ≥75% from Baseline. Full analysis set (FAS) included all study participants who were randomized, received IMP, and had at least 1 valid post-Baseline primary assessment observation.

End point type

Primary

End point timeframe

Baseline, Week 12

Notes
[9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: No formal statistical hypothesis testing was planned for this study. Results were summarized as descriptive statistics only.
[10] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percentage of participants
number (not applicable)	12.3	64.9

No statistical analyses for this end point

Secondary: tmax from Baseline through the End of Study (EoS) Visit of Part A

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End point title

tmax from Baseline through the End of Study (EoS) Visit of Part A ^[11]

End point description

tmax was the time of occurrence of Cmax. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day (D) 1 predose, end of administration and up to D85 (EoS visit) postdose

Notes
[11] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7
Number of subjects analysed	0 ^[12]	0 ^[13]	0 ^[14]	0 ^[15]	0 ^[16]	0 ^[17]	0 ^[18]
Units: hour
median (full range (min-max))	( to )	( to )	( to )	( to )	( to )	( to )	( to )

Notes
[12] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[13] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[14] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[15] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[16] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[17] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[18] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: Cmax from Baseline through the End of Study (EoS) Visit of Part A

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End point title

Cmax from Baseline through the End of Study (EoS) Visit of Part A ^[19]

End point description

Cmax was the maximum observed serum concentration of UCB9741. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day (D) 1 predose, end of administration and up to D85 (EoS visit) postdose

Notes
[19] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7
Number of subjects analysed	0 ^[20]	0 ^[21]	0 ^[22]	0 ^[23]	0 ^[24]	0 ^[25]	0 ^[26]
Units: micrograms/milliliter (μg/mL)
geometric mean (geometric coefficient of variation)	( )	( )	( )	( )	( )	( )	( )

Notes
[20] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[21] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[22] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[23] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[24] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[25] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[26] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: AUC(0-t) from Baseline through the End of Study (EoS) Visit of Part A

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End point title

AUC(0-t) from Baseline through the End of Study (EoS) Visit of Part A ^[27]

End point description

AUC(0-t) was the area under the serum concentration-time curve from time zero to the time of last detectable concentration. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day (D) 1 predose, end of administration and up to D85 (EoS visit) postdose

Notes
[27] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7
Number of subjects analysed	0 ^[28]	0 ^[29]	0 ^[30]	0 ^[31]	0 ^[32]	0 ^[33]	0 ^[34]
Units: day*μg/mL
geometric mean (geometric coefficient of variation)	( )	( )	( )	( )	( )	( )	( )

Notes
[28] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[29] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[30] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[31] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[32] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[33] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[34] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: AUC from Baseline through the End of Study (EoS) Visit of Part A

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End point title

AUC from Baseline through the End of Study (EoS) Visit of Part A ^[35]

End point description

AUC was the area under the serum concentration-time curve from time zero to infinity, calculated as AUC=AUC(0-t)+Clast/ kel, where Clast was the last observed quantifiable serum concentration and kel is the apparent terminal elimination rate constant. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day (D) 1 predose, end of administration and up to D85 (EoS visit) postdose

Notes
[35] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 7
Number of subjects analysed	0 ^[36]	0 ^[37]	0 ^[38]	0 ^[39]	0 ^[40]	0 ^[41]	0 ^[42]
Units: day*μg/mL
geometric mean (geometric coefficient of variation)	( )	( )	( )	( )	( )	( )	( )

Notes
[36] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[37] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[38] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[39] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[40] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[41] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[42] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: Percentage of Participants with ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B

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End point title

Percentage of Participants with ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B ^[43]

End point description

The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities. The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification. The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of atopic dermatitis. An EASI90 response was defined as a 90% or more improvement from Baseline. FAS included all study participants who were randomized, received IMP, and had at least 1 valid post-Baseline primary assessment observation.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[43] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percentage of participants
number (not applicable)	3.5	46.6

No statistical analyses for this end point

Secondary: Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B

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End point title

Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B ^[44]

End point description

The EASI is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities. The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification. The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of atopic dermatitis. Lower values for percent change from Baseline in EASI scores (ie, more negative values) indicated improvement. FAS included all study participants who were randomized, received IMP, and had at least 1 valid post-Baseline primary assessment observation.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[44] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint.

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percent change
least squares mean (standard error)	-24.69 ( 10.461 )	-80.68 ( 6.395 )

No statistical analyses for this end point

Secondary: Bioavailability (F%) of SC administration from Baseline through the End of Study (EoS) Visit of Part A

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End point title

Bioavailability (F%) of SC administration from Baseline through the End of Study (EoS) Visit of Part A ^[45]

End point description

F%= Bioavailability of subcutaneous route. F absolute(%)=(geometric mean AUC sc/geometric mean AUC iv)*(Dose iv/Dose sc)*100. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day (D) 1 predose, end of administration and up to D85 (EoS visit) postdose

Notes
[45] - 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: UCB9741 data for Part B is reported in the separate endpoint. Therefore, no data was reported for Part-B arms in this endpoint.

End point values	Part A: UCB9741 Dose 5	Part A: UCB9741 Dose 6
Number of subjects analysed	0 ^[46]	0 ^[47]
Units: percent bioavailability
geometric mean (confidence interval 95%)	( to )	( to )

Notes
[46] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.
[47] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: Percentage of Participants with ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B

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End point title

Percentage of Participants with ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B ^[48]

End point description

The Eczema Area and Severity Index (EASI) is a validated scoring system that grades the physical signs of atopic dermatitis/eczema. A participant's EASI is scored through evaluation of 4 body regions: Head and neck; Trunk; Upper extremities; Lower extremities. The severity of disease is evaluated by assessing each of 4 clinical signs for each area: Erythema; Edema/papulation; Excoriation; Lichenification. The severity of each clinical sign is scored as: 0=None, 1=Mild, 2=Moderate, 3=Severe. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of atopic dermatitis. An EASI50 response was defined as a 50% or more improvement from Baseline. FAS included all study participants who were randomized, received IMP, and had at least 1 valid post-Baseline primary assessment observation.

End point type

Secondary

End point timeframe

Baseline, Week 12

Notes
[48] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint

End point values	Part B: Placebo	Part B: UCB9741 Dose 6
Number of subjects analysed	14	33
Units: percentage of participants
number (not applicable)	13.6	79.7

No statistical analyses for this end point

Secondary: tmax after the final dose of Part B

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End point title

tmax after the final dose of Part B ^[49]

End point description

End point type

Secondary

End point timeframe

Day 1 predose, end of administration and up to D127

Notes
[49] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint.

End point values	Part B: UCB9741 Dose 6
Number of subjects analysed	0 ^[50]
Units: hour
median (full range (min-max))	( to )

Notes
[50] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: AUCtau after the final dose of Part B

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End point title

AUCtau after the final dose of Part B ^[51]

End point description

AUCtau was the area under the curve for the dosing interval after the final dose. Pharmacokinetic information has not been published due to commercial confidentiality. Once this restriction no longer applies, the information will be made available on this registry.

End point type

Secondary

End point timeframe

Day 1 predose, end of administration and up to D127

Notes
[51] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint

End point values	Part B: UCB9741 Dose 6
Number of subjects analysed	0 ^[52]
Units: day*μg/mL
geometric mean (geometric coefficient of variation)	( )

Notes
[52] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Secondary: Cmax after the final dose of Part B

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End point title

Cmax after the final dose of Part B ^[53]

End point description

End point type

Secondary

End point timeframe

Day 1 predose, end of administration and up to D127

Notes
[53] - 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: UCB9741 data for Part A is reported in the separate endpoint. Therefore, no data was reported for Part-A arms in this endpoint

End point values	Part B: UCB9741 Dose 6
Number of subjects analysed	0 ^[54]
Units: μg/mL
geometric mean (geometric coefficient of variation)	( )

Notes
[54] - Pharmacokinetic data withheld for confidentiality; will be shared once restriction ends.

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Part A: From Baseline up to the End of Study Visit (Week 12); Part B: From Baseline up to the End of Study Visit (Week 18)

Adverse event reporting additional description

A TEAE was defined as any AE with a start date/time on or after the first dose of treatment or any unresolved event already present before administration of treatment that worsened in intensity following exposure to the treatment. SS included all study participants who received at least one dose of study treatment.

Assessment type

Non-systematic

Dictionary name

MedDRA

Dictionary version

27.0

Reporting group title

Part A: UCB9741 Dose 2

Reporting group description

Healthy participants received UCB9741 Dose 2 as a single administration on Day 1. One participant assigned to UCB9741 Dose 2 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: UCB9741 Dose 6

Reporting group description

Healthy participants received UCB9741 Dose 6 as a single administration on Day 1. One participant assigned to UCB9741 Dose 6 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: UCB9741 Dose 5

Reporting group description

Healthy participants received UCB9741 Dose 5 as a single administration on Day 1. One participant assigned to UCB9741 Dose 5 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: Placebo iv

Reporting group description

Healthy participants received placebo (matching to UCB9741) as a single intravenous (iv) administration within each cohort of Part A on Day 1. One participant within each cohort assigned to placebo was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety. Pooled data of placebo (matching to UCB9741) is reported.

Reporting group title

Part A: Placebo sc

Reporting group description

Healthy participants received placebo (matching to UCB9741) as a single subcutaneous (sc) administration within each cohort of Part A on Day 1. One participant within each cohort assigned to placebo was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety. Pooled data of placebo (matching to UCB9741) is reported.

Reporting group title

Part A: UCB9741 Dose 1

Reporting group description

Healthy participants received UCB9741 Dose 1 as a single administration on Day 1. One participant assigned to UCB9741 Dose 1 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: UCB9741 Dose 3

Reporting group description

Healthy participants received UCB9741 Dose 3 as a single administration on Day 1. One participant assigned to UCB9741 Dose 3 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: UCB9741 Dose 4

Reporting group description

Healthy participants received UCB9741 Dose 4 as a single administration on Day 1. One participant assigned to UCB9741 Dose 4 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part A: UCB9741 Dose 7

Reporting group description

Healthy participants received UCB9741 Dose 7 as a single administration on Day 1. One participant assigned to UCB9741 Dose 7 was dosed with a sentinel dosing strategy i.e. participant was dosed at least 24 hours in advance of the rest of the cohort and assessed for safety.

Reporting group title

Part B: UCB9741 Dose 6

Reporting group description

Reporting group title

Part B: Placebo

Reporting group description

Serious adverse events	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 5	Part A: Placebo iv	Part A: Placebo sc	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 7	Part B: UCB9741 Dose 6	Part B: Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Diarrhoea haemorrhagic
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Suicide attempt
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Part A: UCB9741 Dose 2	Part A: UCB9741 Dose 6	Part A: UCB9741 Dose 5	Part A: Placebo iv	Part A: Placebo sc	Part A: UCB9741 Dose 1	Part A: UCB9741 Dose 3	Part A: UCB9741 Dose 4	Part A: UCB9741 Dose 7	Part B: UCB9741 Dose 6	Part B: Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 6 (50.00%)	5 / 6 (83.33%)	6 / 7 (85.71%)	6 / 11 (54.55%)	4 / 5 (80.00%)	4 / 6 (66.67%)	4 / 6 (66.67%)	4 / 6 (66.67%)	4 / 6 (66.67%)	24 / 33 (72.73%)	7 / 14 (50.00%)
General disorders and administration site conditions
Medical device site erythema
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Medical device site dermatitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	0	0	0
Fatigue
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	1 / 14 (7.14%)
occurrences all number	0	0	1	0	0	1	0	0	0	1	1
Vessel puncture site bruise
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Infusion site dermatitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Infusion site pain
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	1	0
Catheter site swelling
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Catheter site bruise
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Injection site erythema
subjects affected / exposed	0 / 6 (0.00%)	2 / 6 (33.33%)	2 / 7 (28.57%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	2	2	0	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	1 / 14 (7.14%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	1
Injection site pain
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Administration site discomfort
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Immune system disorders
Allergy to animal
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Reproductive system and breast disorders
Vulvovaginal pruritus
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	3 / 33 (9.09%)	1 / 14 (7.14%)
occurrences all number	0	1	0	0	0	0	0	0	0	3	1
Throat irritation
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	1 / 6 (16.67%)	2 / 6 (33.33%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	4 / 33 (12.12%)	0 / 14 (0.00%)
occurrences all number	1	2	1	0	0	0	0	0	0	4	0
Psychiatric disorders
Insomnia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0
Investigations
Liver function test abnormal
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0
Injury, poisoning and procedural complications
Ligament sprain
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Nervous system disorders
Anosmia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Tension headache
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Headache
subjects affected / exposed	1 / 6 (16.67%)	2 / 6 (33.33%)	2 / 7 (28.57%)	2 / 11 (18.18%)	2 / 5 (40.00%)	0 / 6 (0.00%)	2 / 6 (33.33%)	1 / 6 (16.67%)	2 / 6 (33.33%)	4 / 33 (12.12%)	1 / 14 (7.14%)
occurrences all number	1	2	2	4	2	0	2	1	2	5	1
Hypogeusia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Dizziness
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	4 / 33 (12.12%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	4	0
Gastrointestinal disorders
Toothache
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Diarrhoea
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	3 / 33 (9.09%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	2
Nausea
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Vomiting
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1
Skin and subcutaneous tissue disorders
Dermatitis
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Dermatitis contact
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0
Dry skin
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	1	0
Eczema
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	1	0
Erythema
subjects affected / exposed	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	0
Pruritus
subjects affected / exposed	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Rash maculo-papular
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Dermatitis atopic
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	3 / 14 (21.43%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	5
Renal and urinary disorders
Dysuria
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Myalgia
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0
Arthralgia
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	1 / 11 (9.09%)	1 / 5 (20.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	4 / 33 (12.12%)	1 / 14 (7.14%)
occurrences all number	0	0	0	1	1	0	0	1	0	5	1
Tinea barbae
subjects affected / exposed	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	1 / 33 (3.03%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0
Tooth infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
COVID-19
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 6 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	2 / 6 (33.33%)	3 / 33 (9.09%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0	2	3	0
Oral candidiasis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	1 / 6 (16.67%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	2 / 33 (6.06%)	1 / 14 (7.14%)
occurrences all number	0	0	1	0	0	0	0	0	0	2	1
Pharyngitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	0 / 14 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	1 / 7 (14.29%)	0 / 11 (0.00%)	1 / 5 (20.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	4 / 33 (12.12%)	3 / 14 (21.43%)
occurrences all number	0	0	1	0	1	0	0	0	0	4	4
Vulvovaginal candidiasis
subjects affected / exposed	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 7 (0.00%)	0 / 11 (0.00%)	0 / 5 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 6 (0.00%)	0 / 33 (0.00%)	1 / 14 (7.14%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1

More information

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Were there any global substantial amendments to the protocol? Yes

01 Mar 2021

Protocol Amendment 2 (dated 01 Mar 2021) was implemented to clarify the relevant pharmacokinetic (PK) and safety data to be provided to the Safety Monitoring Committee (SMC) to allow decisions to be made on dose escalation (Part A) and transition to Part B. Aligned the PK sampling times relative to the start of the infusion/injection and included electrocardiogram (ECGs) on Day 71 (final IMP administration).

13 Aug 2021

Protocol Amendment 3 (dated 13 Aug 2021) was implemented to reduce the number of overnight stays and allowed the use of mild TCS prescribed by the investigator during Part B of the study once blinded treatment had commenced but not prior to randomization.

12 Nov 2021

Protocol Amendment 4 (dated 12 Nov 2021) was implemented to revise the eligibility criteria to ensure that the study population enrolled was representative of patients with moderate-to-severe AtD and allowed COVID-19 and inactivated flu vaccines for Part B of the study.

20 Oct 2022

Protocol Amendment 5 (dated 20 Oct 2022) was implemented to remove the requirement for in-clinic overnight stays after SMC review. Additionally, some eligibility criteria were revised following requests from local regulatory authorities.

02 May 2023

Protocol Amendment 7 (dated 01 May 2023) was implemented to reduce sample size in alignment with the removal of a decision criterion for the primary analysis, as it was for sponsor decision making only. Sample size was based only on the difference in the primary efficacy variable between galvokimig and placebo.

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 of participants with treatment-emergent adverse events (TEAEs) during Part A

Primary: Percentage of participants with treatment-emergent adverse events (TEAEs) during Part A

Primary: Percentage of Participants with treatment-emergent serious adverse events (TESAEs) during Part A

Primary: Percentage of Participants with treatment-emergent serious adverse events (TESAEs) during Part A

Primary: Percentage of Participants with TEAEs during Part B

Primary: Percentage of Participants with TEAEs during Part B

Primary: Percentage of Participants with TESAEs during Part B

Primary: Percentage of Participants with TESAEs during Part B

Primary: Percentage of Participants with ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B

Primary: Percentage of Participants with ≥75% improvement vs Baseline in Eczema Area and Severity Index (EASI75) score during Part B

Secondary: tmax from Baseline through the End of Study (EoS) Visit of Part A

Secondary: tmax from Baseline through the End of Study (EoS) Visit of Part A

Secondary: Cmax from Baseline through the End of Study (EoS) Visit of Part A

Secondary: Cmax from Baseline through the End of Study (EoS) Visit of Part A

Secondary: AUC(0-t) from Baseline through the End of Study (EoS) Visit of Part A

Secondary: AUC(0-t) from Baseline through the End of Study (EoS) Visit of Part A

Secondary: AUC from Baseline through the End of Study (EoS) Visit of Part A

Secondary: AUC from Baseline through the End of Study (EoS) Visit of Part A

Secondary: Percentage of Participants with ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B

Secondary: Percentage of Participants with ≥90% improvement vs Baseline in EASI score (EASI90) at Week 12 during Part B

Secondary: Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B

Secondary: Percent change from Baseline in the Eczema Area and Severity Index (EASI) score at Week 12 of Part B

Secondary: Bioavailability (F%) of SC administration from Baseline through the End of Study (EoS) Visit of Part A

Secondary: Bioavailability (F%) of SC administration from Baseline through the End of Study (EoS) Visit of Part A

Secondary: Percentage of Participants with ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B

Secondary: Percentage of Participants with ≥50% improvement vs Baseline in EASI score (EASI50) at Week 12 during Part B

Secondary: tmax after the final dose of Part B

Secondary: tmax after the final dose of Part B

Secondary: AUCtau after the final dose of Part B

Secondary: AUCtau after the final dose of Part B

Secondary: Cmax after the final dose of Part B

Secondary: Cmax after the final dose of Part B

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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