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
1 other identifier
interventional
200
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2025
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2025
CompletedFirst Posted
Study publicly available on registry
April 27, 2025
CompletedStudy Start
First participant enrolled
June 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 7, 2026
August 17, 2025
August 1, 2025
1.1 years
April 25, 2025
August 12, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percent change from Baseline in Eczema Area and Severity Index (EASI) at 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.
Baseline, Week 24
Study Arms (5)
Group 1
PLACEBO COMPARATORGroup 2
EXPERIMENTALGroup 3
EXPERIMENTALGroup 4
EXPERIMENTALGroup 5
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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;
You may not qualify if:
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- Pregnancy.
- Other.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University People's hospital
Beijing, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jianzhong Zhang
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 25, 2025
First Posted
April 27, 2025
Study Start
June 19, 2025
Primary Completion (Estimated)
July 18, 2026
Study Completion (Estimated)
November 7, 2026
Last Updated
August 17, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share