RecruitingPhase 2NCT06947980

Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis

Sponsor

Keymed Biosciences Co.Ltd

Enrollment

200 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Atopic Dermatitis

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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;
% 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 Criteria5

Not enough washing-out period for previous therapy.
Concurrent disease/status which may potentially affect the efficacy/safety judgement.
Organ dysfunction.
Pregnancy.
Other.

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