The Study of CM310 in Patients With Atopic Dermatitis

Study Overview
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Brief Summary
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This is an open, multicenter, extension study evaluating the safety and efficacy of CM310 for long-term treatment in patients with atopic dermatitis The primary objective is to assess the long-term safety of CM310 administered in patients with atopic dermatitis (AD).

Detailed Description
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The secondary objective of the study is to assess the immunogenicity of CM310 in patients with AD, in the context of re-treatment, and to monitor efficacy parameters associated with long-term treatment.

Official Title
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An Open, Multicenter,Open-label Extension Study to Evaluate the Safety and Efficacy of CM310 in Patients With Atopic Dermatitis

Conditions
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Moderate-to-severe Atopic Dermatitis

Intervention / Treatment
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* Biological: CM310


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participation in a prior clinical trial of CM310 for AD(CM310AD001 and CM310AD002) and met one of the following: Participation in CM310AD001:received study treatment and adequately completed the assessments and completed the EOS(D85±7) visit. Participation in CM310AD002 and met one of the following：i: Received study treatment and adequately completed the assessments and completed the EOS(V12) visit. ii:Treatment termination due to other reasons other than poor compliance or AE related to CM310 , completed the EOS visit . Provide signed informed consent Exclusion Criteria: Patients who, during their participation in a previous CM310 clinical trial, developed a SAE/AE deemed related to dupilumab*, which in the opinion of the investigator or of the medical monitor could not suitable to continue the treatment with CM310. Not enough washing-out period for previous therapy. Pregnancy. Other

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CM310<br>adults and teenagers (12   18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12   18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC. | Biological: CM310<br>* adults and teenagers (12   18 years) with weight ≥60 kg : 600mg for 1st dose, and then 300 mg, every 2 weeks and up to 1 year, SC. teenagers (12   18 years) with weight ≥30 kg and <60kg : 400mg for 1st dose, and then 200 mg, every 2 weeks and up to 1 year, SC.<br>* Other names: IL-4Rα monoclonal antibody;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Treatment Emergent Adverse Events (TEAEs) | The primary endpoint in the study is the incidence and rate (events per patient-year) of TEAEs | Up to 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Serious Adverse Events (SAEs) and Adverse Event of special interest(AESI) | Incidence and rate (events per patient-year) of SAEs and AESIs | Up to 2 Years | 
| Proportion of patients with Eczema Area and Severity Index (EASI)-75 (≥75 percent reduction in EASI scores from baseline of the parent study) at each visit | 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 | Up to 2 Years | 
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 and decline ≥2 points from baseline at each visit | Proportion of patients who achieve and maintain a score of 0 to 1 on the IGA scale [(a 6-point scale ranging from 0 (clear) to 5 (very severe)] | Up to 2 Years | 
| Proportion of patients with Eczema Area and Severity Index (EASI)-90 (≥90 percent reduction in EASI scores from baseline of the parent study) at each visit | 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 | Up to 2 Years | 
| Proportion of patients with Eczema Area and Severity Index (EASI)-50 (≥50 percent reduction in EASI scores from baseline of the parent study) at each visit | 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 | Up to 2 Years | 
| Change from baseline in EASI score at each visit | 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 | Up to 2 Years | 
| Proportion of patients with Investigator's Global Assessment (IGA) score = 0-1 at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to 2 Years | 
| Proportion of patients with IGA reduction from baseline of ≥2 points at each visit | IGA is a 6-point scale ranging from 0 (clear) to 5 (very severe) | Up to 2 Years | 
| Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥4 points from baseline | Proportion of subjects with improvement (reduction) of pruritus NRS of ≥4 points from baseline. The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years | 
| Proportion of patients with reduction of Pruritus Numerical Rating Scale (NRS) of ≥3 points from baseline | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years | 
| Percent change from baseline in NRS | The range of NRS is from 0 (no itch)-10 (worst imaginable itch) | Up to 2 Years | 
| Body Surface Area (BSA) | Change from baseline in percent of BSA | Up to 2 Years | 
| Time to first remission (achieving IGA = 0 or 1) |  | Up to 2 Years | 
| Time to first relapse (eg, IGA >2) after remission or to not achieving remission |  | Up to 2 Years | 
| Time to first EASI-50/75/90 |  | Up to 2 Years | 
| Proportion of patients requiring rescue treatment: Overall/Systemic treatment/Immunosuppressor/Systemic treatment |  | Up to 2 Years | 
| Number of days on topical medication (per patient-year) |  | Up to 2 Years | 
| Changes from baseline to prespecified time points through the end of the study: Dermatology Life Quality Index (DLQI) | The DLQI is a 10-item, validated questionnaire used in clinical practice and clinical trials to assess the impact of AD disease symptoms and treatment on quality of life (QOL) (Badia 1999). The format is a simple response to 10 items, which assess QOL over the past week, with an overall scoring system of 0 to 30; a high score is indicative of a poor QOL | Up to 2 Years | 
| immunogenicity | Detection of anti-drug antibody (ADA) | Up to 2 Years | 
| Pharmacokinetics parameters | trough concentration of CM310 | Up to 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic Dermatitis