Tezepelumab Efficacy and Safety in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma

Summary

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Timeline

Start

2022-08-09

Primary completion

2025-03-24

Completion

2025-03-24

Outcome

Met primary endpoint

Stopped (Enrollment): “The study was discontinued due to slow recruitment, resulting from evolving clinical practices that reduced the use of maintenance oral corticosteroids for severe asthma treatment. The termination decision was not related to safety concerns.”

registry analysis (superiority test); Tezepelumab vs Placebo; p = 0.003; Cumulative Odds Ratio 2.93 (95% CI 1.43 to 6.03); Proportional odds model NCT05398263 ↗

paper In this study, tezepelumab treatment led to greater reductions from baseline in daily oral corticosteroid dose than placebo at week 28 despite early study termination. PMID 42150582 ↗

Publications

• Wechsler ME, Brightling CE, Brusselle G, Caminati M, Soler T, Gonzalez EM, Nakwan N, Capala-Szczurko I, Hunter G, Almqvist G, Lal H, Kabelis P, Scrigner P, Matsunaga Y, Molfino N, Ponnarambil SS; SUNRISE study investigators. Efficacy and safety of tezepelumab versus placebo in reducing oral corticosteroid use in adults with severe, oral corticosteroid-dependent asthma (SUNRISE): a multicentre, placebo-controlled, double-blind, phase 3 trial. Lancet Respir Med. 2026 Jun;14(6):481-492. doi: 10.1016/S2213-2600(26)00076-7. Epub 2026 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tezepelumab	Monoclonal antibody	210 mg	Subcutaneous

Indications