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

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

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

Indications