Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
A Randomized, Double Blind, Placebo-Controlled Phase IIb Study to Evaluate the Efficacy and Safety of CM310 Recombinant Humanized Monoclonal Antibody Injection in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
1 other identifier
interventional
120
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Feb 2021
Shorter than P25 for phase_2
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2021
CompletedFirst Submitted
Initial submission to the registry
March 14, 2021
CompletedFirst Posted
Study publicly available on registry
March 18, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2021
CompletedApril 15, 2022
November 1, 2021
9 months
March 14, 2021
April 13, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
EASI-75
Proportion of subjects with EASI-75 (≥75 percent improvement from baseline)
at Week 16
Secondary Outcomes (12)
Investigator's Global Assessment (IGA) 0/1
at week 16
reduction of IGA from baseline of ≥ 2 points
at week 16
The Eczema Area and Severity Index (EASI)-90
at week 16
The Eczema Area and Severity Index (EASI)-50
at week 16
Improvement of Numerical Rating Scale (NRS)
at week 16
- +7 more secondary outcomes
Study Arms (3)
High-dose arm
EXPERIMENTAL600mg for 1st dose, and then 300 mg for 2-8nd doses, every 2 weeks, SC
low-dose arm
EXPERIMENTAL300mg for 1st dose, and then 150 mg for 2-8nd doses, every 2 weeks, SC
placebo
PLACEBO COMPARATORplacebo for 1-8 doses, every 2 weeks, SC
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- pregnancy.
- Other.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Friendship Hospital，Capital Medical University
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2021
First Posted
March 18, 2021
Study Start
February 24, 2021
Primary Completion
November 8, 2021
Study Completion
November 8, 2021
Last Updated
April 15, 2022
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share