NCT06116565
Not yet recruiting
Phase 2
An Multi-center, Open-label, Single-arm Phase 2 Study to Evaluate the Long-term Safety and Efficacy of CM310 in Subjects With Moderate-to-severe Atopic Dermatitis
Keymed Biosciences Co.Ltd0 sites300 target enrollmentMarch 30, 2024
ConditionsAtopic Dermatitis
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Atopic Dermatitis
- Sponsor
- Keymed Biosciences Co.Ltd
- Enrollment
- 300
- Primary Endpoint
- Adverse events (AEs)
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Adverse events (AEs)
Time Frame: up to Week 60
Incidence of adverse events (AEs).
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