Status:
COMPLETED
A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic derma...
Detailed Description
The study consists of an up-to-4-week screening period, a 16-week double-blind treatment period, a 36-week maintenance treatment period, and a 8-week safety follow-up period.
Eligibility Criteria
Inclusion
- Diagnosed with AD for at least 12 months before Screening, with below requirements: 1) EASI score ≥16 at Screening and Baseline; 2) IGA score ≥3 at Screening and Baseline; 3) ≥10% BSA of AD involvement at Screening and Baseline; 4) Pruritus NRS average score ≥3 at Baseline.
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 :
April 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 25 2023
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT05265923
Start Date
April 22 2022
End Date
December 25 2023
Last Update
November 8 2024
Active Locations (1)
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1
Peking University People's hospital
Beijing, China