NCT07358780

Remibrutinib in Real-world Clinical Practice - a US Sub-study

Remibrutinib in Real-world Clinical Practice: a Prospective, Multi-country, Non-interventional, Effectiveness and Safety Study - a US Sub-study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 505 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, a new treatment option, covering a broader, real-world clinical practice population.

Detailed description

This is a prospective, non-interventional study in patients with CSU where the treatment decision prior enrolment has been made to either escalate current sgH1-AHs treatment or escalate/switch current treatment to remibrutinib. The primary aim of this study is to gather real-world effectiveness and safety data for remibrutinib, covering a broader, real-world clinical practice population. This local US study is part of an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program (CLOU064A2402).

Conditions

• Chronic Spontaneous Urticaria

Timeline

• Start date: 2026-02-02
• Primary completion: 2029-09-30
• Completion: 2029-09-30
• First posted: 2026-01-22
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States