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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 June 19, 2025, with plans to enroll 200 participants. Led by Keymed Biosciences Co.Ltd, it is expected to complete by November 7, 2026. The latest data from ClinicalTrials.gov was last updated on August 17, 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