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

Phase 2

Recruiting

• Conditions: Atopic Dermatitis
• Interventions: Biological: CM512; Drug: Placebo Comparator

• Registration Number: NCT06947980
• Lead Sponsor: Keymed Biosciences Co.Ltd

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-25
• Study First Submitted QC: 2025-04-25
• Study First Posted: 2025-04-27
• Study Start: 2025-06-19
• Status Verified: 2025-08
• Last Update Submitted: 2025-08-12
• Last Update Posted: 2025-08-17
• Primary Completion: 2026-07-18
• Study Completion: 2026-11-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3	CM512	-
Group 1	Placebo Comparator	-
Group 2	CM512	-
Group 5	Placebo Comparator	-
Group 4	CM512	-

Primary Outcome Measures

Name	Time	Method
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24	Baseline, Week 24	The EASI score is used to measure the severity and extent of AD and measured erythema, edema/papulation, excoriation and lichenification on 4 anatomic regions of the body: head and neck, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD.

Trial Locations

Locations (1)

Peking University People's hospital; 🇨🇳 Beijing, China