Study of CM310 in Adolescent Subjects With Atopic Dermatis
Phase 3
Not yet recruiting
- Conditions
- Atopic Dermatitis
- Interventions
- Biological: CM310
- Registration Number
- NCT06495229
- Lead Sponsor
- Keymed Biosciences Co.Ltd
- Brief Summary
This is a multi-center, single arm, open label phase 3 study to evaluate the safety and efficacy of CM310 in children patients with moderate-to-severe atopic dermatitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 180
Inclusion Criteria
- Have the ability to understand the study and voluntarily sign a written informed consent form (ICF).
- Subjects who must complete the evaluation of Week 18 of the main study.
- With Atopic Dermatitis.
Exclusion Criteria
- Any major surgery planned during the research period.
- Subjects with potential fertility do not agree to adopt efficient contraceptive measures throughout the entire study period; Pregnant or breastfeeding women, or women planning to conceive or breastfeed during the study period.
- With any circumstance that the subject is not suitable to participate in this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CM310 group CM310 -
- Primary Outcome Measures
Name Time Method Adverse events up to week 52 Incidence of adverse events.
- Secondary Outcome Measures
Name Time Method