Anti-IgE Monoclonal Antibody Treatment in Patients With Allergic Asthma.

Phase 3 Completed 393 enrolled Shanghai Biomabs Pharmaceutical Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a multi-centre, randomized, double-blind，placebo parallel-controlled phase III study to evaluate the efficacy and safety of CMAB007 (recombinant humanized anti-immunoglobulin E(IgE) monoclonal antibody for injection) to treat asthma patients who remain not adequately controlled despite Med/high ICS plus LABA in China. Following a screening period of up to 2 weeks and run-in period of 4 weeks, randomized patients will enter a 24-week treatment period with CMAB007 or placebo. Efficacy and safety will be assessed at 4-week intervals during the treatment period.

Timeline

Start: 2018-05-09
Primary completion: 2021-01-12
Completion: 2021-03-09

Outcome

Met primary endpoint

paper AE rate was 0.45 with CMAB007 and 0.66 with placebo (hazard ratio, 0.68; 95% confidence interval, 0.49, 0.96; P = 0.030). PMID 41345745 ↗

Publications

Lai K, Yan Z, Qian D, Zhang X, Bian T, Dai X, Li H, Lin L, Wang J, Wang L, Yang J, Hu Y, Li H, Nie X, Jin F, Li G, Sun S, Xu F, Zhao H, Chen Y, Liu C, Zhu H, Li J, Guo Y, Zhong N. Benefits of CMAB007 in Chinese Patients Having Inadequately Controlled Moderate/Severe Asthma With Increased Total IgE: A Randomized Phase 3 Trial. Allergy Asthma Immunol Res. 2026 Jan;18(1):39-54. doi: 10.4168/aair.2026.18.1.39. Epub 2025 Nov 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CMAB007	Monoclonal antibody	375 mg	Subcutaneous
Background	Salbutamol	Unknown	—	—
Background	Seretide	Unknown	—	Inhaled
Background	Symbicort	Unknown	—	Inhaled