Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM) - PubMed

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Remibrutinib, an oral BTK inhibitor, and dupilumab, an IL-4 receptor-α monoclonal antibody, are compared in the RECLAIM study for treating chronic spontaneous urticaria (CSU).
The study is a US-based, multicenter, randomized, double-blind, double-dummy trial involving 400 patients with moderate-to-severe CSU unresponsive to second-generation H1-antihistamines.
Patients receive either oral remibrutinib (25 mg twice daily) or subcutaneous dupilumab (600 mg loading dose; 300 mg every 2 weeks) alongside standard treatment.
Primary endpoint: Absolute change from baseline in weekly Urticaria Activity Score (UAS7) at week 4.
Secondary endpoints include UAS7 changes at week 1, itch and hives severity scores at week 4, disease control metrics, and safety assessments.
Exclusion criteria include prior use of remibrutinib, BTK inhibitors, or dupilumab, and presence of other urticaria-related skin conditions.
The study includes a 4-week screening, 12-week core treatment, and 12-week safety follow-up period.
RECLAIM aims to evaluate early efficacy differences between remibrutinib and dupilumab in CSU patients.
The study is currently recruiting participants (ClinicalTrials.gov ID: NCT06868212).
Authors disclose conflicts of interest, including funding, consulting roles, and affiliations with pharmaceutical companies.

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