Status:
RECRUITING
Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
Lead Sponsor:
Keymed Biosciences Co.Ltd
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Eligibility Criteria
Inclusion
- Patients with a diagnosis of AD for at least 1 year according to the American Academy of Dermatology's consensus criteria prior to the screening visit meeting all of the following criteria:
- EASI≥16 at Screening and Baseline visits;
- Investigator's Global Assessment (IGA) score of≥3 at Screening and Baseline visits;
- 10% Body Surface Area (BSA) of AD involvement at Screening and Baseline visits;
- Mean of weekly Pruritus Numeric Rating Scale (NRS) severity score≥4 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 :
June 19 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 7 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06947980
Start Date
June 19 2025
End Date
November 7 2026
Last Update
August 17 2025
Active Locations (1)
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1
Peking University People's hospital
Beijing, China