Clinical Trials in China / NCT06947980
Recruiting
Phase 2
Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
NCT06947980 · tracked via the Priya Life Science China tracker
Condition(s) studied
Atopic Dermatitis
Investigational drug(s) / intervention(s)
Placebo ComparatorCM512 →
Placebo Comparator: Placebo subcutaneous injection
CM512: CM512 subcutaneous injection
Study summary
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Eligibility
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.
Primary outcome measure(s)
- 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 sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Peking University People's hospital | Beijing | China | Recruiting |
More Keymed Biosciences Co.Ltd trials in China
Other trials for the same condition
A Study To Learn About Two Study Medicines (PF-07275315 And PF-07264660) In People Who Have Moderate To Severe Atopic Dermatitis
Active, not recruiting
A Phase I Clinical Trial to Evaluate CU-10101 Unguent
Enrolling by invitation
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06947980 on ClinicalTrials.gov ↗ ← All trials in China