Rademikibart Treatment for Moderate-to-Severe Uncontrolled Asthma: A Phase 2B Randomized Clinical Trial.

ABSTRACT: Rationale: Rademikibart (formerly CBP-201) is an IL-4Rα-targeting antibody. Objectives: We sought to evaluate rademikibart in adults with moderate-to-severe, persistent, uncontrolled asthma. Methods: In this global Phase 2b trial, 322 patients were randomized 1:1:1 to two rademikibart groups (150 mg or 300 mg every other week, after a 600-mg loading dose) or a placebo group; rademikibart or placebo was administered subcutaneously for 24 weeks. Measurements and Main Results: Prebronchodilator (trough) forced expiratory volume in 1 second (FEV₁) at Week 12 (primary endpoint) improved with rademikibart at 150 mg and 300 mg: Least squares mean changes (95% confidence interval), above placebo, were 140 ml (44-236 ml; P = 0.005) and 189 ml (92-286 ml

SUBMITTER: Kerwin E 

PROVIDER: S-EPMC12091008 | biostudies-literature | 2025 May

REPOSITORIES: biostudies-literature