NCT07465120

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Dermavon Holdings Limited · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Approximately 160 participants with moderate to severe atopic dermatitis are planned to be enrolled and randomly assigned to four groups in a 1:1:1:1 ratio. Stratification will be performed based on participants' baseline IGA scores (3 or 4) at the time of randomization. Each participant will receive study treatment once daily (QD) for 12 consecutive weeks. The dosage and frequency for each group are as follows: Trial Group 1: CMS-D001 50 mg, QD; Trial Group 2: CMS-D001 100 mg, QD; Trial Group 3: CMS-D001 200 mg, QD; Control Group: Placebo, QD. The study is divided into three phases: a Screening Period (up to 4 weeks), a Treatment Period (12 weeks), and a Safety Follow-up Period (4 weeks after the last dose). During the study, all participants must adhere to the study visit schedule to undergo efficacy and safety assessments. They will also be required to complete blood sample collections for Pharmacokinetic (PK) and Pharmacodynamic (PD) evaluations, and information regarding Adverse Events (AEs) and concomitant medications will be collected.

Conditions

• Moderate to Severe Atopic Dermatitis

Interventions

Type	Name	Description
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	Placebo QD

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-01-31
• Completion: 2027-05-31
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

28 sites across 1 country: China