Recruiting NCT06947980
Study of CM512 in Patients With Moderate-to-Severe Atopic Dermatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placebo Comparator, CM512.
- Who it may be relevant to
- Registry conditions: Atopic Dermatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
A Phase 2 study designed to evaluate the efficacy and safety of CM512 in adult patients with moderate-to-severe Atopic Dermatitis (AD).
Interventions
- Drug Placebo Comparator
Placebo subcutaneous injection - Biological CM512
CM512 subcutaneous injection
Primary outcome measures
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 24 [Time frame: Baseline, Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University People's hospital — Beijing
Identifiers
NCT: NCT06947980 · CM512-101102