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Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy.

Summary
EudraCT number	2013-002470-46
Trial protocol	GB DE
Global end of trial date	06 Jun 2016

Results information
Results version number	v1(current)
This version publication date	30 Jun 2017
First version publication date	30 Jun 2017
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

CIM003JG

ISRCTN number

US NCT number

NCT01986933

WHO universal trial number (UTN)

Sponsor organisation name

Chugai Pharma Europe Ltd.

Sponsor organisation address

Mulliner House, Flanders Road, London, United Kingdom, W4 1NN

Public contact

Clinical trials information, Chugai Pharmaceutical Co., Ltd., +81 332730934, clinical-trials@chugai-pharm.co.jp

Scientific contact

Clinical trials information, Chugai Pharmaceutical Co., Ltd., +81 332730934, clinical-trials@chugai-pharm.co.jp

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

09 Sep 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

01 Apr 2015

Global end of trial reached?

Yes

Global end of trial date

06 Jun 2016

Was the trial ended prematurely?

Main objective of the trial

To evaluate the dose response profile of CIM331 in the treatment of pruritus as defined by the percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus VAS (Part A).

Protection of trial subjects

This study was conducted in full conformance with the ICH E6 guideline for GCP and the principles of the Declaration of Helsinki, or the laws and regulations of the country in which the research is conducted, whichever affords the greater protection to the individual.

Background therapy

Evidence for comparator

Actual start date of recruitment

17 Dec 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Yes

Number of subjects enrolled per country

Country: Number of subjects enrolled

Poland: 66

Country: Number of subjects enrolled

United Kingdom: 7

Country: Number of subjects enrolled

Germany: 53

Country: Number of subjects enrolled

United States: 59

Country: Number of subjects enrolled

Japan: 79

Worldwide total number of subjects

264

EEA total number of subjects

126

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)

264

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

The study was conducted at 57 study sites in 5 countries. A total of 397 subjects were screened between 25 Nov 2013 and 30 Dec 2014. 264 subjects were randomized and treated. 114 subjects were screen failures and 19 subjects were run-in failures due to exclusion and inclusion criteria not met.

Screening details

Randomization was stratified by region (US, Europe and Japan). Assignment to arms was done centrally in 1:1:1:1:1 ratio for Nemolizumab (0.1mg/kg Q4W, 0.5mg/kg Q4W, 2.0mg/kg Q4W, 2.0mg/kg Q8W) and Placebo.

Period 1 title

12-week placebo-controlled period (Pt A)

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

In order to maintain the blind, Nemolizumab and the placebo formulation were of identical volume and provided in identical containers.

Are arms mutually exclusive

Yes

Placebo

Arm description

Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

Arm type

Placebo

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (0.1 mg/kg) q4w

Arm description

Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (0.5 mg/kg) q4w

Arm description

Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (2.0 mg/kg) q4w

Arm description

Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (2.0 mg/kg) q8w

Arm description

Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Number of subjects in period 1	Placebo	Nemolizumab (0.1 mg/kg) q4w	Nemolizumab (0.5 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q8w
Started	53	53	54	52	52
Completed	44	44	45	45	38
Not completed	9	9	9	7	14
Consent withdrawn by subject	5	2	6	2	7
Withdrawal by subject due to lack of efficacy	-	-	-	-	2
Adverse event, non-fatal	1	5	2	2	4
Lost to follow-up	-	1	-	1	-
Lack of efficacy	3	1	1	2	1

Period 2 title

64wks Active(PtA)+Active Treatment(PtB)

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Monitor, Carer, Assessor

Blinding implementation details

In order to maintain the blind, Nemolizumab and the placebo formulation were of identical volume and provided in identical containers.

Are arms mutually exclusive

Yes

Nemolizumab (0.1 mg/kg) q4w

Arm description

CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (0.5 mg/kg) q4w

Arm description

CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (2.0 mg/kg) q4w

Arm description

CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Nemolizumab (2.0 mg/kg) q8w

Arm description

Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections every 4 weeks for 12 weeks. Patients in this dosing group received placebo at Week 12, Nemolizumab at Week 16, and then alternating doses of placebo and Nemolizumab.

Arm type

Experimental

Investigational medicinal product name

Nemolizumab

Investigational medicinal product code

CIM331

Other name

Pharmaceutical forms

Solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

subcutaneous injection in non-lesional abdomen at 20 μL/kg.

Number of subjects in period 2 ^[1]	Nemolizumab (0.1 mg/kg) q4w	Nemolizumab (0.5 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q8w
Started	41	38	39	35
Completed	31	28	30	19
Not completed	10	10	9	16
Consent withdrawn by subject	4	7	6	6
Physician decision	-	1	1	-
Withdrawal by subject due to lack of efficacy	-	-	-	1
Adverse event, non-fatal	2	-	1	3
Patient return PIC due to skin worsening	-	-	1	-
Pregnancy	-	-	-	1
Lost to follow-up	-	-	-	1
Lack of efficacy	3	2	-	4
Met Withdrawal Criteria	1	-	-	-

Notes
[1] - 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: It was optional for patients to participate in the part B of the study, therefore some patients decided to decline and not participate in part B.

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

Reporting group title

Nemolizumab (0.1 mg/kg) q4w

Reporting group description

Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (0.5 mg/kg) q4w

Reporting group description

Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q4w

Reporting group description

Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q8w

Reporting group description

Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

Reporting group values	Placebo	Nemolizumab (0.1 mg/kg) q4w	Nemolizumab (0.5 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q8w	Total
Number of subjects	53	53	54	52	52	264
Age categorical
Data is reported for the 264 treatred subjects included in the analyses.
Units: Subjects
Adults (18-64 years)	53	53	54	52	52	264
Age continuous
Data is reported for the 264 treatred subjects included in the analyses.
Units: years
arithmetic mean (standard deviation)	37 ± 13.1	33.5 ± 10.3	33.7 ± 11.7	34.4 ± 11.9	35.8 ± 13.6	-
Gender categorical
Data is reported for the 264 treated subjects included in the analyses.
Units: Subjects
Female	28	25	32	21	23	129
Male	25	28	22	31	29	135

Subject analysis set title

Intent to treat

Subject analysis set type

Intention-to-treat

Subject analysis set description

ITT population will include all patients who receive at least one dose of double-blind study drug. Patients who receive study drug different from that to which they are randomized will be included in the group to which they are randomized.

Subject analysis sets values	Intent to treat
Number of subjects	264
Age categorical
Data is reported for the 264 treatred subjects included in the analyses.
Units: Subjects
Adults (18-64 years)	264
Age continuous
Data is reported for the 264 treatred subjects included in the analyses.
Units: years
arithmetic mean (standard deviation)	34.9 ± 12.1
Gender categorical
Data is reported for the 264 treated subjects included in the analyses.
Units: Subjects
Female	129
Male	135

End points

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Reporting group title

Placebo

Reporting group description

Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

Reporting group title

Nemolizumab (0.1 mg/kg) q4w

Reporting group description

Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (0.5 mg/kg) q4w

Reporting group description

Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q4w

Reporting group description

Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q8w

Reporting group description

Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

Reporting group title

Nemolizumab (0.1 mg/kg) q4w

Reporting group description

CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks

Reporting group title

Nemolizumab (0.5 mg/kg) q4w

Reporting group description

CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Reporting group title

Nemolizumab (2.0 mg/kg) q4w

Reporting group description

CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Reporting group title

Nemolizumab (2.0 mg/kg) q8w

Reporting group description

Subject analysis set title

Intent to treat

Subject analysis set type

Intention-to-treat

Subject analysis set description

Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

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End point title

The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS) ^[1]

End point description

Pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch).

End point type

Primary

End point timeframe

Baseline and week 12

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: Statistical analysis was not performed on the other arm that were not reported.

End point values	Placebo	Nemolizumab (0.1 mg/kg) q4w	Nemolizumab (0.5 mg/kg) q4w	Nemolizumab (2.0 mg/kg) q4w
Number of subjects analysed	46	46	45	47
Units: percent
least squares mean (confidence interval 95%)	-20.07 (-29.94 to -10.21)	-41.46 (-51.21 to -31.71)	-61.24 (-71.13 to -51.35)	-60.46 (-69.98 to -50.95)

Difference in % change

Statistical analysis description

The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.

Comparison groups

Placebo v Nemolizumab (0.1 mg/kg) q4w

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.0027

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-21.39

Confidence interval

level

95%

sides

2-sided

lower limit

-35.25

upper limit

-7.53

Difference in % change

Statistical analysis description

The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.

Comparison groups

Placebo v Nemolizumab (0.5 mg/kg) q4w

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[2]

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-41.16

Confidence interval

level

95%

sides

2-sided

lower limit

-55.17

upper limit

-27.15

Notes
[2] - Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons exists, and the global 1-sided significance alpha level of 0.025 is maintained.

Difference in % change

Statistical analysis description

The primary analysis of the percent improvement VAS from baseline in pruritus VAS to Week 12 will be the pairwise comparison of each CIM331 Q4W dose against placebo.

Comparison groups

Placebo v Nemolizumab (2.0 mg/kg) q4w

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001 ^[3]

Method

ANCOVA

Parameter type

Mean difference (final values)

Point estimate

-40.39

Confidence interval

level

95%

sides

2-sided

lower limit

-54.11

upper limit

-26.67

Notes
[3] - Since a hierarchical decision procedure can be regarded as a closed testing procedure, no inflation of the alpha level due to multiple comparisons exists, and the global 1-sided significance alpha level of 0.025 is maintained.

Adverse events

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Timeframe for reporting adverse events

Period 1 : 12-week placebo-controlled period (Part A) Period 2 : 64wks Active (Part A) + Active Treatment (Part B) (Part A+B)

Adverse event reporting additional description

The Investigator is responsible for ensuring that all adverse events are recorded on the Adverse Event eCRF and reported to the Sponsor. For each adverse event recorded on the Adverse Event eCRF, the Investigator will make an assessment of seriousness, severity, and causality.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

16.1

Reporting group title

Placebo (Part A)

Reporting group description

Placebo: subcutaneous injections every 4 weeks on Day 1, Week 4 and Week 8

Reporting group title

Nemolizumab (0.1 mg/kg) q4w (Part A)

Reporting group description

Nemolizumab (0.1 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (0.5 mg/kg) q4w (Part A)

Reporting group description

Nemolizumab (0.5 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q4w (Part A)

Reporting group description

Nemolizumab (2.0 mg/kg) q4w: subcutaneous injections every 4 weeks for 12 weeks

Reporting group title

Nemolizumab (2.0 mg/kg) q8w (Part A)

Reporting group description

Nemolizumab (2.0 mg/kg) q8w: subcutaneous injections Dose on Day 1 and at Week 8, placebo at Week 4.

Reporting group title

Nemolizumab (0.1 mg/kg) q4w (Part A + B)

Reporting group description

CIM331 (0.1 mg/kg) was given subcutaneously every 4 weeks for 64 weeks

Reporting group title

Nemolizumab (0.5 mg/kg) q4w (Part A + B)

Reporting group description

CIM331 (0.5 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Reporting group title

Nemolizumab (2.0 mg/kg) q4w (Part A + B)

Reporting group description

CIM331 (2.0 mg/kg) given subcutaneously every 4 weeks for 64 weeks.

Reporting group title

Nemolizumab (2.0 mg/kg) q8w (Part A + B)

Reporting group description

Serious adverse events	Placebo (Part A)	Nemolizumab (0.1 mg/kg) q4w (Part A)	Nemolizumab (0.5 mg/kg) q4w (Part A)	Nemolizumab (2.0 mg/kg) q4w (Part A)	Nemolizumab (2.0 mg/kg) q8w (Part A)	Nemolizumab (0.1 mg/kg) q4w (Part A + B)	Nemolizumab (0.5 mg/kg) q4w (Part A + B)	Nemolizumab (2.0 mg/kg) q4w (Part A + B)	Nemolizumab (2.0 mg/kg) q8w (Part A + B)
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 53 (1.89%)	1 / 53 (1.89%)	0 / 54 (0.00%)	3 / 52 (5.77%)	5 / 52 (9.62%)	3 / 53 (5.66%)	3 / 54 (5.56%)	4 / 52 (7.69%)	9 / 52 (17.31%)
number of deaths (all causes)	0	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0		0	0	0	0	0	0
Injury, poisoning and procedural complications
Upper limb fracture
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 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
Joint dislocation
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 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
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Coronary artery stenosis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Parkinson's disease
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Grand mal convulsion
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	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
Eye disorders
Retinal detachment
subjects affected / exposed	1 / 53 (1.89%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	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
Cataract
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Non-alcoholic steatohepatitis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	2 / 52 (3.85%)	1 / 52 (1.92%)	0 / 53 (0.00%)	1 / 54 (1.85%)	2 / 52 (3.85%)	2 / 52 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 2	0 / 1	0 / 0	0 / 1	1 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Urticaria
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	1 / 54 (1.85%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Rash
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	1 / 54 (1.85%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Infections and infestations
Pyoderma
subjects affected / exposed	0 / 53 (0.00%)	1 / 53 (1.89%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	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
Skin infection
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	1 / 1	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
Herpes zoster
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dermatitis exfoliative
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Herpes simplex
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Infection
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	2 / 52 (3.85%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	2 / 52 (3.85%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	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	Placebo (Part A)	Nemolizumab (0.1 mg/kg) q4w (Part A)	Nemolizumab (0.5 mg/kg) q4w (Part A)	Nemolizumab (2.0 mg/kg) q4w (Part A)	Nemolizumab (2.0 mg/kg) q8w (Part A)	Nemolizumab (0.1 mg/kg) q4w (Part A + B)	Nemolizumab (0.5 mg/kg) q4w (Part A + B)	Nemolizumab (2.0 mg/kg) q4w (Part A + B)	Nemolizumab (2.0 mg/kg) q8w (Part A + B)
Total subjects affected by non serious adverse events
subjects affected / exposed	36 / 53 (67.92%)	38 / 53 (71.70%)	36 / 54 (66.67%)	40 / 52 (76.92%)	37 / 52 (71.15%)	47 / 53 (88.68%)	46 / 54 (85.19%)	52 / 52 (100.00%)	43 / 52 (82.69%)
Investigations
Blood creatine phosphokinase increased
subjects affected / exposed	3 / 53 (5.66%)	2 / 53 (3.77%)	2 / 54 (3.70%)	4 / 52 (7.69%)	3 / 52 (5.77%)	5 / 53 (9.43%)	3 / 54 (5.56%)	9 / 52 (17.31%)	6 / 52 (11.54%)
occurrences all number	3	2	2	4	3	6	7	14	6
Nervous system disorders
Headache
subjects affected / exposed	0 / 53 (0.00%)	3 / 53 (5.66%)	2 / 54 (3.70%)	3 / 52 (5.77%)	1 / 52 (1.92%)	3 / 53 (5.66%)	6 / 54 (11.11%)	5 / 52 (9.62%)	2 / 52 (3.85%)
occurrences all number	0	5	3	3	4	6	10	5	3
Dizziness
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	3 / 53 (5.66%)	0 / 54 (0.00%)	0 / 52 (0.00%)	2 / 52 (3.85%)
occurrences all number	0	0	0	0	0	3	0	0	2
General disorders and administration site conditions
Oedema peripheral
subjects affected / exposed	0 / 53 (0.00%)	2 / 53 (3.77%)	3 / 54 (5.56%)	5 / 52 (9.62%)	2 / 52 (3.85%)	2 / 53 (3.77%)	3 / 54 (5.56%)	6 / 52 (11.54%)	2 / 52 (3.85%)
occurrences all number	0	3	3	6	3	3	3	8	3
Blood and lymphatic system disorders
Lymphadenopathy
subjects affected / exposed	3 / 53 (5.66%)	2 / 53 (3.77%)	1 / 54 (1.85%)	1 / 52 (1.92%)	1 / 52 (1.92%)	3 / 53 (5.66%)	1 / 54 (1.85%)	1 / 52 (1.92%)	2 / 52 (3.85%)
occurrences all number	3	2	1	1	1	3	1	1	3
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	2 / 53 (3.77%)	3 / 54 (5.56%)	1 / 52 (1.92%)	1 / 52 (1.92%)
occurrences all number	0	0	0	0	0	2	3	2	1
Asthma
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	3 / 53 (5.66%)	0 / 54 (0.00%)	1 / 52 (1.92%)	0 / 52 (0.00%)
occurrences all number	0	0	0	0	0	3	0	1	0
Skin and subcutaneous tissue disorders
Dermatitis atopic
subjects affected / exposed	7 / 53 (13.21%)	11 / 53 (20.75%)	10 / 54 (18.52%)	9 / 52 (17.31%)	9 / 52 (17.31%)	15 / 53 (28.30%)	12 / 54 (22.22%)	12 / 52 (23.08%)	9 / 52 (17.31%)
occurrences all number	8	12	11	11	10	20	15	14	11
Urticaria
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	3 / 54 (5.56%)	1 / 52 (1.92%)	1 / 52 (1.92%)
occurrences all number	0	0	0	0	0	1	5	3	1
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	2 / 54 (3.70%)	3 / 52 (5.77%)	2 / 52 (3.85%)
occurrences all number	0	0	0	0	0	1	2	5	3
Infections and infestations
Nasopharyngitis
subjects affected / exposed	8 / 53 (15.09%)	9 / 53 (16.98%)	6 / 54 (11.11%)	5 / 52 (9.62%)	7 / 52 (13.46%)	15 / 53 (28.30%)	14 / 54 (25.93%)	15 / 52 (28.85%)	12 / 52 (23.08%)
occurrences all number	8	12	8	7	11	33	31	25	21
Upper respiratory tract infection
subjects affected / exposed	6 / 53 (11.32%)	4 / 53 (7.55%)	1 / 54 (1.85%)	4 / 52 (7.69%)	5 / 52 (9.62%)	6 / 53 (11.32%)	3 / 54 (5.56%)	5 / 52 (9.62%)	5 / 52 (9.62%)
occurrences all number	7	5	1	4	5	8	8	9	6
Folliculitis
subjects affected / exposed	3 / 53 (5.66%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	1 / 52 (1.92%)	1 / 53 (1.89%)	0 / 54 (0.00%)	1 / 52 (1.92%)	3 / 52 (5.77%)
occurrences all number	3	0	0	0	1	1	0	1	3
Impetigo
subjects affected / exposed	0 / 53 (0.00%)	4 / 53 (7.55%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	6 / 53 (11.32%)	3 / 54 (5.56%)	0 / 52 (0.00%)	3 / 52 (5.77%)
occurrences all number	0	4	0	0	0	7	3	0	3
Influenza
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	5 / 53 (9.43%)	1 / 54 (1.85%)	2 / 52 (3.85%)	0 / 52 (0.00%)
occurrences all number	0	0	0	0	0	5	1	2	0
Pharyngitis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	3 / 54 (5.56%)	3 / 52 (5.77%)	1 / 52 (1.92%)
occurrences all number	0	0	0	0	0	1	3	3	1
Bronchitis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	3 / 53 (5.66%)	2 / 54 (3.70%)	2 / 52 (3.85%)	0 / 52 (0.00%)
occurrences all number	0	0	0	0	0	3	2	2	0
Cystitis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	3 / 54 (5.56%)	1 / 52 (1.92%)	1 / 52 (1.92%)
occurrences all number	0	0	0	0	0	2	3	1	1
Sinusitis
subjects affected / exposed	0 / 53 (0.00%)	0 / 53 (0.00%)	0 / 54 (0.00%)	0 / 52 (0.00%)	0 / 52 (0.00%)	1 / 53 (1.89%)	3 / 54 (5.56%)	1 / 52 (1.92%)	1 / 52 (1.92%)
occurrences all number	0	0	0	0	0	1	3	1	1

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Were there any global substantial amendments to the protocol? No

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

Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

Adverse events

Adverse events

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Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

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Clinical trials

Clinical Trial Results: A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy.

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

Primary: The percent improvement in pruritus from baseline to Week 12, assessed by patients using the pruritus visual analogue scale (VAS)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase II, randomized, double-blind, placebo-controlled, multiple-dose study to evaluate the safety, tolerability, and efficacy of CIM331 in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy.