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

Summary

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.

Timeline

Start

2025-07-11

Primary completion

2027-02-22

Completion

2027-05-17

Publications

• Yosipovitch G, Mosnaim G, Ortmann CE, Griswold N, Mast J, Martzloff ED, Rodrigues J, Hawkes JE. Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM). Dermatol Ther (Heidelb). 2026 May;16(5):2575-2585. doi: 10.1007/s13555-026-01716-y. Epub 2026 Mar 19.

Drugs

Indications