Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Phase 3 Completed 180 enrolled Keymed Biosciences Co.Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, pharmacokinetics(PK), pharmacodynamics(PD) and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

Timeline

Start: 2024-03-21
Primary completion: 2025-01-23
Completion: 2025-01-23

Outcome

Met primary endpoint

paper higher proportions of patients treated with stapokibart than those treated with placebo achieved EASI 75 PMID 41697953 ↗

paper 73.9% (n = 88/119) vs. 43% (n = 26/60); difference: 30.5% (95% confidence interval 15.3-44.3; P < 0.001) PMID 41697953 ↗

paper 57.1% (n = 68/119) vs. 25% (n = 15/60); difference: 31.8% (95% confidence interval 16.6-44.4; P < 0.001) PMID 41697953 ↗

Publications

Zhou C, Zhao Y, Zhu G, Wu L, Liu Y, Tao X, Zhao H, Wei Z, Lu W, Li W, Ding Y, Zhu X, Hu G, Cheng H, Xiao R, Man XY, Wang Q, Li S, Zeng T, Wang L, Xu Y, Zhang L, Liu W, Zhao G, Jia Y, Huang Y, Chen B, Zhang J. Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicentre randomized double-blind placebo-controlled phase III trial. Br J Dermatol. 2026 May 19;194(6):1067-1076. doi: 10.1093/bjd/ljag052.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CM310	Monoclonal antibody	300 mg	Subcutaneous