A Study of CM310 in Subjects With Moderate-to-Severe Atopic Dermatitis
Phase 2
Not yet recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: CM310
- Registration Number
- NCT06116565
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief Summary
This is a multi-center, open-label phase 2 study to evaluate the long-term safety and efficacy of CM310 in subjects with moderate-to-severe atopic dermatitis.
- Detailed Description
The study consists of an screening period, treatment period, and safety follow-up period.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Age ≥ 18 and ≤ 75 years old.
- With Atopic Dermatitis.
Exclusion Criteria
- Not enough washing-out period for previous therapy.
- Concurrent disease/status which may potentially affect the efficacy/safety judgement.
- Major surgeries are planned during the study period.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 CM310 -
- Primary Outcome Measures
Name Time Method Adverse events (AEs) up to Week 60 Incidence of adverse events (AEs).
- Secondary Outcome Measures
Name Time Method