The Study of CM326 in Moderate-to-severe Atopic Dermatitis

Study Overview
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Brief Summary
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This is a multi-center, randomized, double blind, placebo-controlled study to evaluate the efficacy, safety, tolerance, pharmacokinetics, pharmacodynamics, and immunogenicity of CM326 in moderate-severe atopic dermatitis subjects.

Detailed Description
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The study consists of 3 periods, a up-to-4-week Screening Period, a 52-week Treatment Period and a 8-week Safety Follow-up Period.

Official Title
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A Randomized, Double-blind, Placebo-controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of CM326 Injection in the Treatment of Adult Patients With Moderate-to-severe Atopic Dermatitis

Conditions
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Moderate-to-severe Atopic Dermatitis

Intervention / Treatment
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* Biological: CM326
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With confirmed Atopic Dermatitis (AD) at the screening. Age ≥ 18 years and ≤ 75 years, male or female. Have the ability to understand the nature of the study and voluntarily sign the informed consent. Be able to communicate well with investigators and follow up protocol requirements. Exclusion Criteria: Not enough washing-out period for previous therapy. Received allergen specific immunotherapy (desensitization) within 6 months prior to baseline. Major surgery is planned during the study period. Women who are pregnant or breastfeeding, or who plan to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>Group A: CM326, subcutaneous (SC) | Biological: CM326<br>* CM326 injection<br>|
| Experimental: Group B<br>Group A: CM326, subcutaneous (SC) | Biological: CM326<br>* CM326 injection<br>|
| Placebo Comparator: Group C<br>Group C: placebo, subcutaneous (SC) | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline) at visit 16 | The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 to 72 points, with the higher scores reflecting the worse severity of AD | at week 16 | 
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and reduction from baseline of ≥2 points at Visit 16 | IGA is a 5-point scale ranging from 0 (clear) to 4 (very severe) | at week 16 |