A Phase 2 Study of CIM331 for Atopic Dermatitis Patients

Study Overview
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Brief Summary
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To assess the safety, tolerability and efficacy of CIM331, compared to placebo, in atopic dermatitis patients who are inadequately controlled by or intolerant to topical therapy

Official Title
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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

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Drug: nemolizumab (CIM331)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥18 and ≤65 years of age at the time of consent. Patients with Atopic Dermatitis Pruritus visual analogue scale (VAS) ≥50 mm at the screening and baseline visit Eczema Area and Severity Index (EASI) ≥10 at the screening and baseline visit static Investigator's Global Assessment (sIGA) score ≥3 at the baseline visit Exclusion Criteria: Serological evidence of hepatitis B virus or hepatitis C virus infection Known human immunodeficiency virus infection Ongoing treatment with specific or non-specific hyposensitization therapy for AD Treatment with mild or moderately potent topical corticosteroids (TCS) within 1 week prior to randomization History of infection including skin infection requiring treatment with oral or intravenous (IV) antibiotics, antivirals, or antifungals within 1 week prior to randomization. Evidence of tuberculosis (TB) infection as defined by a positive purified protein derivative (PPD) and/or positive interferon-gamma release assay. Pregnant or lactating women.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group1<br>Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) | Drug: nemolizumab (CIM331)<br> <br> |
| Experimental: Group2<br>Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) | Drug: nemolizumab (CIM331)<br> <br> |
| Experimental: Group3<br>Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) | Drug: nemolizumab (CIM331)<br> <br> |
| Experimental: Group4<br>Part A: nemolizumab (CIM331) Part B: nemolizumab (CIM331) | Drug: nemolizumab (CIM331)<br> <br> |
| Experimental: Group5<br>Part A: Placebo Part B: nemolizumab (CIM331) | Drug: nemolizumab (CIM331)<br> <br> Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Changes From Baseline in Pruritus Visual Analogue Scale (VAS) at Week 12 | Percent changes from baseline in pruritus VAS at Week 12. VAS indicates pruritus intensity in the last 24 hours, from 0 (no itch) to 10 (worst imaginable itch). When condition of pruritus improves, percent change from baseline at Week 12 indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A, PP Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A) | 
| Changes From Baseline in Eczema Area and Severity Index (EASI) (Part A + Part B, ITT Long Population) | EASI score was used to measure the severity and extent of atopic eczema. The intensity of a representative area of eczema and the approximate percentage affected by eczema were calculated for each of the four body regions: head and neck, upper limbs, trunk, and lower limbs. The sum of the above 4 body region scores was calculated and should be 0 (none) to 72 (severest). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) | 
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A, PP Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A) | 
| Changes From Baseline in SCORing Atopic Dermatitis (SCORAD) (Part A + Part B, ITT Long Population) | SCORAD is a clinical tool used to assess the extent and severity of eczema. Area and intensity, were assessed by the Investigator and subjective symptoms were reported by the patient in order to determine an overall score. The score should be 0 to 103: mild [<25], moderate [25-50] or severe [>50]). When the condition of eczema improves, the percent change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) | 
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A, PP Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A) | 
| Changes From Baseline in Static Investigator's Global Assessment (sIGA) (Part A + Part B, ITT Long Population) | The sIGA consisted of a 6-point severity scale from clear to very severe disease (0 = clear, 1 = almost clear, 2 = mild disease, 3 = moderate disease, 4 = severe disease and 5 = very severe disease). The sIGA assessed clinical characteristics of erythema, infiltration, papulation, oozing and crusting for the overall severity assessment at the time of evaluation. When the skin condition improves, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the condition improves). | baseline to Week 12 (Part A), up to Week 64 (Part B) | 
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A, PP Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | baseline to Week 12 (Part A) | 
| Changes From Baseline in Body Surface Area (BSA) of Atopic Dermatitis (AD) Involvement (Part A + Part B, ITT Long Population) | The total BSA affected by AD was assessed as part of SCORAD. The BSA is a measure of the severity of AD, and it is considered to be severe when the rash with strong inflammation is 10 % or more of the total BSA. When the BSA of AD involvement decreases, the change from baseline at each timepoint indicates negative value (i.e. the higher the absolute value is, the more the BSA of AD involvement decreases). | baseline to Week 12 (Part A), up to Week 64 (Part B) |