Efficacy and safety of stapokibart in adolescents with moderate-to-severe atopic dermatitis: a multicenter, randomized, double-blind, placebo-controlled phase 3 trial - PubMed
6 days ago
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- #atopic dermatitis
- #clinical trial
- Stapokibart, a novel humanized monoclonal antibody targeting IL-4Rα, was evaluated for efficacy and safety in adolescents with moderate-to-severe atopic dermatitis (AD).
- The phase 3 trial was multicenter, randomized, double-blind, and placebo-controlled, involving 180 patients (120 on stapokibart, 60 on placebo).
- Patients received stapokibart 300 mg (loading dose 600 mg) or placebo for 18 weeks, with dosing frequency based on weight (every 2 weeks for ≥60 kg, every 3 weeks for 30-<60 kg).
- Primary endpoints were EASI-75 (≥75% improvement in Eczema Area and Severity Index) and IGA response (Investigator's Global Assessment score of 0/1 with ≥2-point reduction) at week 18.
- Stapokibart showed significantly higher efficacy than placebo: 73.9% vs. 43.3% achieved EASI-75, and 57.1% vs. 25.0% achieved IGA response (both P<0.0001).
- Stapokibart also significantly improved itch reduction (36.1% vs. 15.0% achieved ≥4-point reduction in Peak Pruritus Numerical Rating Scale, P=0.0037).
- Safety profiles were similar between stapokibart (62.5% adverse events) and placebo (61.7% adverse events), with no reported conjunctivitis.
- The study concluded that stapokibart is highly effective and safe for treating moderate-to-severe AD in adolescents.