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Recruiting Phase 2 NCT06947980

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

Trial Parameters

Condition Atopic Dermatitis
Sponsor Keymed Biosciences Co.Ltd
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 200
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2025-06-19
Completion 2026-07-18
Interventions
Placebo ComparatorCM512

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 Criteria: * 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 Criteria: * 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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