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Clinical Trial NCT06947980 for Atopic Dermatitis is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis Phase 2 200
Clinical Trial NCT06947980 is designed to study Treatment for Atopic Dermatitis. It is a Phase 2 interventional study that is recruiting, having started on 19 June 2025, with plans to enroll 200 participants. Led by Keymed Biosciences Co.Ltd, it is expected to complete by 7 November 2026. The latest data from ClinicalTrials.gov was last updated on 17 August 2025.
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).
Official Title
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
Conditions
Atopic DermatitisOther Study IDs
- CM512-101102
NCT ID Number
Start Date (Actual)
2025-06-19
Last Update Posted
2025-08-17
Completion Date (Estimated)
2026-11-07
Enrollment (Estimated)
200
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Triple
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Placebo ComparatorGroup 1 | Placebo Comparator Placebo subcutaneous injection |
ExperimentalGroup 2 | CM512 CM512 subcutaneous injection |
ExperimentalGroup 3 | CM512 CM512 subcutaneous injection |
ExperimentalGroup 4 | CM512 CM512 subcutaneous injection |
Placebo ComparatorGroup 5 | Placebo Comparator Placebo subcutaneous injection |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
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;
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Organ dysfunction.
- Pregnancy.
- Other.
Keymed Biosciences Co.LtdStudy Central Contact
Contact: Qian Jia, +86-028-88610620, [email protected]
1 Study Locations in 1 Countries
Peking University People's hospital, Beijing, China
Jianzhong Zhang, Contact, 15545433012, [email protected]
Recruiting