drugset / Trial / NCT05265923
A Study of CM310 in Patients With Moderate-to-Severe Atopic Dermatitis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in patients with moderate-to-severe atopic dermatitis.
Timeline
- Start
- 2022-04-22
- Primary completion
- 2023-10-31
- Completion
- 2023-12-25
Publications
- Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Zhao W, Chu W, Chen B, Zhang J. Efficacy and Safety of Stapokibart in Adults With Moderate-to-Severe Atopic Dermatitis With and Without Type 2 Comorbidities: A Post Hoc Analysis of a Phase 3 Trial. Clin Transl Allergy. 2025 Nov;15(11):e70121. doi: 10.1002/clt2.70121.
- Zhao Y, Zhang L, Wu L, Yang B, Wang J, Li Y, Diao Q, Li J, Sun Q, Zhu X, Man X, Wang L, Feng Y, Cai T, Zeng H, Li L, Lu J, Ren H, Li F, Lu Q, Tao X, Xiao R, Ji C, Liang C, Qiu Y, Chen B, Zhang J. Patient-Reported Outcomes in Adults with Moderate-to-Severe Atopic Dermatitis Treated with Stapokibart over 52 weeks: A Post Hoc Analysis of a Phase 3 Trial. Adv Ther. 2025 Sep;42(9):4527-4539. doi: 10.1007/s12325-025-03284-7. Epub 2025 Jul 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CM310 | Monoclonal antibody | 300 mg | Subcutaneous |