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
A US Phase 3b, Multi-center, Randomized, Double-blind, Double-Dummy 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
Novartis Pharmaceuticals
400 participants
Jul 11, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Film-coated tablet, oral administration, 25 mg b.i.d.
Film-coated tablet, oral administration, b.i.d.
Solution for injection in pre-filled syringe 600 mg loading dose followed by 300 mg dose every 2 weeks
Solution for injection in pre-filled syringe every 2 weeks
Locations(114)
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NCT06868212