Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
- Conditions
- Moderate-to-severe Atopic Dermatitis
- Interventions
- Biological: CM310Biological: Placebo
- Registration Number
- NCT04805411
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief Summary
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.
- Detailed Description
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- Diagnosed as AD for at least 12 months before Screening, with below requirements: 1)EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 (0-5 points scale) at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
- Inadequate response to topical medications.
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- pregnancy.
- Other.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description High-dose arm CM310 600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC placebo Placebo placebo for 1-8 doses, every 2 weeks, SC low-dose arm CM310 300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC
- Primary Outcome Measures
Name Time Method EASI-75 at Week 16 Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
- Secondary Outcome Measures
Name Time Method Pharmacodynamics Baseline to Week 24 Total IgE level
Investigator's Global Assessment (IGA) 0/1 at week 16 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.
The Eczema Area and Severity Index (EASI)-50 at week 16 Proportion of subjects with EASI-50 (≥50 percent improvement from baseline)
Pharmacokinetics parameters Baseline to Week 24 trough concentration and exposure of CM310
immunogenicity Baseline to Week 24 Detection of anti-drug antibody (ADA)
Improvement of Numerical Rating Scale (NRS) at week 16 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).
Body Surface Area (BSA) Baseline to Week 24 Change from baseline in percent of BSA
Safety parameters Baseline to Week 24 Incidence of AE, abnormal physical examinations, abnormal vital signs, abnormal ECG, and abnormal lab testing.
reduction of IGA from baseline of ≥ 2 points at week 16 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.
The Eczema Area and Severity Index (EASI)-90 at week 16 Proportion of subjects with EASI-90 (≥90 percent improvement from baseline)
Dermatology Life Quality Index (DLQI) Baseline to Week 24 Change from baseline in DLQI
Trial Locations
- Locations (25)
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Dermatology Hospital of Southern Medical University
🇨🇳Guangzhou, Guangdong, China
Beijing Chao-Yang Hospital, Capital Medical University
🇨🇳Beijing, Beijing, China
Chongqing Traditional Chinese Hospital
🇨🇳Chongqing, Chongqing, China
Beijing Friendship Hospital，Capital Medical University
🇨🇳Beijing, Beijing, China
Wuxi Second Hospital
🇨🇳Wuxi, Jiangsu, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
Second Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, 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
Yantai Yuhuangding Hospital
🇨🇳Yantai, Shandong, China
West China Hospital of Sichuan University
🇨🇳Chengdu, Sichuan, China
Shanghai Skin Disease Hospital
🇨🇳Shanghai, Shanghai, China
Affiliated Hospital of Qingdao University
🇨🇳Qingdao, Shandong, China
Second Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
🇨🇳Tianjin, Tianjin, China
Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Hangzhou First People's Hospital
🇨🇳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
Peking University Third Hospital
🇨🇳Beijing, Beijing, China