A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅱ Clinical Study to Evaluate the Efficacy and Safety of CMS-D001 in Adult Patients With Moderate to Severe Atopic Dermatitis
NCT07465120 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 160
Last updated 2026-03-11
Summary
This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial, aiming to evaluate the efficacy, safety, and tolerability of CMS-D001 in participants with moderate to severe atopic dermatitis, as well as to assess the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of CMS-D001 and its major metabolites (as applicable) in participants with moderate to severe atopic dermatitis, so as to provide a basis for the dosage of the Phase III confirmatory clinical trial.
Conditions
- Moderate to Severe Atopic Dermatitis
Interventions
- DRUG
-
CMS-D001 50mg
CMS-D001 50mg QD
- DRUG
-
CMS-D001 100mg
CMS-D001 100mg QD
- DRUG
-
CMS-D001 200mg
CMS-D001 200mg QD
- DRUG
-
Placebo QD
Sponsors & Collaborators
-
Dermavon Holdings Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-20
- Primary Completion
- 2027-01-31
- Completion
- 2027-05-31
Countries
- China
Study Locations
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