3상모집 중
A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistamines
연구 개요
This is a US, multi-center, randomized, double-blind, double-dummy, Phase 3b study to evaluate efficacy of remibrutinib (25 mg twice daily \[b.i.d.\] by mouth \[p.o.\]) compared to dupilumab (600 mg loading dose administered subcutaneously (s.c.) followed by 300 mg every 2 weeks s.c.) at early timepoints (4 weeks and earlier), when administered as an add-on treatment to second generation H1-antihistamines (sgH1-AH) (standard label dose as background therapy) in adult US participants with moderate to severe chronic spontaneous urticaria (CSU) inadequately controlled by sgH1-AHs.
- 스폰서
- 리드: 노바티스
- 적응증
- Chronic Spontaneous Urticaria (CSU)
- 중재
- Remibrutinib, Remibrutinib matching placebo, Dupilumab, Placebo solution for injection
- 목표 등록
- 400명
- 시작일
- 2025-07-11
- 완료(예정)
- 2027-05-17
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