Status:
COMPLETED
Subcutaneously CM310/Placebo in Patients With Moderate-to-Severe Atopic Dermatitis (AD)
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Moderate-to-severe Atopic Dermatitis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 cons...
Detailed Description
Subjects will be required to apply moisturizers after ICF signed and continue throughout the study.
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- pregnancy.
- Other.
Key Trial Info
Start Date :
February 24 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2021
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT04805411
Start Date
February 24 2021
End Date
November 8 2021
Last Update
April 15 2022
Active Locations (25)
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1
Beijing Chao-Yang Hospital, Capital Medical University
Beijing, Beijing Municipality, China
2
Beijing Friendship Hospital，Capital Medical University
Beijing, Beijing Municipality, China
3
Peking University People's Hospital
Beijing, Beijing Municipality, China
4
Peking University Third Hospital
Beijing, Beijing Municipality, China