FAsenra Safety Trial in India

Summary

Benralizumab is a humanised, afucosylated, monoclonal antibody that binds specifically to the human interlukin-5 (IL-5) receptor alpha subunit (IL-5Rα) of target cells such as eosinophils and basophils (Takatsu et al, 1994; Toba et al, 1999; Pelaia et al, 2020). Benralizumab was generally well tolerated by patients in clinical trials, with no apparent safety concerns. This study shall be conducted at 10 centers across India. The primary outcome measures will be * Percentage of AEs a, SAEs, and TEAEs * Nature, incidence, and severity of AEs including unexpected adverse drug reactions * Percentage of patients with AEs that lead to study treatment discontinuations.

Timeline

Start

2021-11-19

Primary completion

2023-07-01

Completion

2023-07-01

Publications

• Talwar D, Maturu VN, Meshram PL, Mittal S, Praveen JV, Guleria R, Kumar A, Agarwal A, Verma AK, Mohan M, Narasimhan R, Jain N, Sharma R, Kumar R, Parakh U, Momi G. Safety and effectiveness of benralizumab in Indian patients with severe eosinophilic asthma: results from the FAST study. Front Med (Lausanne). 2026 Apr 20;13:1706737. doi: 10.3389/fmed.2026.1706737. eCollection 2026.

Drugs

Indications

No indication recorded.