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This is a multi-center, randomized, double blind, placebo-controlled phase IIb study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in moderate-severe AD subjects. The study consists of 3 periods, a up-to-4-week Screening Period, a 16-week randomized Treatment Period and a 8-week Safety Follow-up Period.
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-dose arm | Experimental | 600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC |
|
| low-dose arm | Experimental | 300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC |
|
| placebo | Placebo Comparator | placebo for 1-8 doses, every 2 weeks, SC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM310 | Biological | IL-4Rα monoclonal antibody |
| |
| Measure | Description | Time Frame |
|---|---|---|
| EASI-75 | Proportion of subjects with EASI-75 (≥75 percent improvement from baseline) | at Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Investigator's Global Assessment (IGA) 0/1 | Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points. | at week 16 |
| reduction of IGA from baseline of ≥ 2 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Chao-Yang Hospital, Capital Medical University | Beijing | Beijing Municipality | China | |||
| Beijing Friendship Hospital,Capital Medical University |
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| Placebo |
| Biological |
Placebo |
|
Proportion of subjects with IGA 0 or 1 (on a 6-point scale, range from 0-5 point, higher scores mean a worse disease severity) and a reduction from baseline of ≥2 points. |
| at week 16 |
| The Eczema Area and Severity Index (EASI)-90 | Proportion of subjects with EASI-90 (≥90 percent improvement from baseline) | at week 16 |
| The Eczema Area and Severity Index (EASI)-50 | Proportion of subjects with EASI-50 (≥50 percent improvement from baseline) | at week 16 |
| Improvement of Numerical Rating Scale (NRS) | 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). | at week 16 |
| Body Surface Area (BSA) | Change from baseline in percent of BSA | Baseline to Week 24 |
| Dermatology Life Quality Index (DLQI) | Change from baseline in DLQI | Baseline to Week 24 |
| Safety parameters | Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing. | Baseline to Week 24 |
| Pharmacokinetics parameters | trough concentration and exposure of CM310 | Baseline to Week 24 |
| Pharmacodynamics | Serum Thymus and activation regulated chemokine (TARC) | Baseline to Week 24 |
| Pharmacodynamics | Total IgE level | Baseline to Week 24 |
| immunogenicity | Detection of anti-drug antibody (ADA) | Baseline to Week 24 |
| Beijing |
| Beijing Municipality |
| China |
| Peking University People's Hospital | Beijing | Beijing Municipality | China |
| Peking University Third Hospital | Beijing | Beijing Municipality | China |
| Chongqing Traditional Chinese Hospital | Chongqing | Chongqing Municipality | China |
| Dermatology Hospital of Southern Medical University | Guangzhou | Guangdong | China |
| Second Xiangya Hospital of Central South University | Changsha | Hunan | China |
| The Third Xiangya Hospital of Central South University | Changsha | Hunan | China |
| Wuxi Second Hospital | Wuxi | Jiangsu | China |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China |
| First Hospital of Jilin University | Changchun | Jilin | China |
| Second Hospital of Jilin University | Changchun | Jilin | China |
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| Shandong Provincial Hospital of Dermatology | Jinan | Shandong | China |
| Affiliated Hospital of Qingdao University | Qingdao | Shandong | China |
| Yantai Yuhuangding Hospital | Yantai | Shandong | China |
| Shanghai Skin Disease Hospital | Shanghai | Shanghai Municipality | China |
| Second Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |
| West China Hospital of Sichuan University | Chengdu | Sichuan | China |
| Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital | Tianjin | Tianjin Municipality | China |
| Hangzhou First People's Hospital | Hangzhou | Zhejiang | China |
| Second Affiliated Hospital Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Sir Run Run Shaw Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | China |
| Zhejiang Provincial People's Hospital | Hangzhou | Zhejiang | China |
| Ningbo Second Hospital | Ningbo | Zhejiang | China |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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