Study of CM310 in Subjects With Allergic Rhinitis

Summary

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study aimed at evaluating the efficacy and safety of CM310 in patients with seasonal allergic rhinitis, and observing the quality of life, PK, PD characteristics, and immunogenicity of subjects.

Timeline

Start

2023-08-10

Primary completion

2023-12-04

Completion

2023-12-04

Outcome

Met primary endpoint

paper Compared with the placebo, stapokibart led to a significant improvement in the mean change from baseline in daily rTNSS during the 2-week PMID 40186079 ↗

paper (least-squares mean difference, -1.3; 95% confidence interval, -2.0 to -0.6; P = 0.0008) PMID 40186079 ↗

Publications

• Zhang Y, Li J, Wang M, Li X, Yan B, Liu J, Shi L, Cao Z, Feng Y, Liu W, Xu Z, Ma R, Gao X, Liu W, Xue J, Ren X, Li X, Song X, Yang Y, Wang Y, Xing Z, Quan F, Pan J, Sun Y, Shi F, Chen X, Yan H, Zhao G, Chen B, Wang C, Zhang L. Stapokibart for moderate-to-severe seasonal allergic rhinitis: a randomized phase 3 trial. Nat Med. 2025 Jul;31(7):2213-2221. doi: 10.1038/s41591-025-03651-5. Epub 2025 Apr 4.
• Wang M, Zhang Y, Li J, Wang C, Zhang L. Stapokibart (CM310) in patients with uncontrolled seasonal allergic rhinitis (PHECDA): Rationale and design of a multicentre, randomized, double-blind, placebo-controlled study. Asia Pac Allergy. 2025 Mar;15(1):15-20. doi: 10.5415/apallergy.0000000000000174. Epub 2025 Jan 13.
• Zhang Y, Yan B, Zhu Z, Wang X, Song X, Zhu D, Ma T, Zhang Y, Meng C, Wang G, Wang C, Zhang L. Efficacy and safety of stapokibart (CM310) in uncontrolled seasonal allergic rhinitis (MERAK): an investigator-initiated, placebo-controlled, randomised, double-blind, phase 2 trial. EClinicalMedicine. 2024 Feb 6;69:102467. doi: 10.1016/j.eclinm.2024.102467. eCollection 2024 Mar.

Drugs

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

Indications