Status:
COMPLETED
The Study of CM310 in Patients With Atopic Dermatitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 sa...
Detailed Description
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 treatmen...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 3 2023
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT04893707
Start Date
June 7 2021
End Date
February 3 2023
Last Update
November 8 2024
Active Locations (1)
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1
Peking University People's hospital
Beijing, China