NCT07358364

Remibrutinib in Real-world Clinical Practice

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 3,280 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Prospective, multi-country, 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, multi-country, 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. The study employs an umbrella design which brings the evidence needs from multiple countries under the REASSERT global program. Countries will generate local protocol to be used in their country; the local study documentation will be a minimised version of the global document, modified to align with country's evidence needs, given local disparities in treatment guidelines, access, physician type and ePROs/eDiaries used. To achieve the core objectives the observation needs to include either the Urticaria Control Test (UCT) or Urticaria Activity Score over 7 days (UAS7) and the Dermatology Life Quality Index (DLQI). Data from all countries will be pooled and analyzed globally. In certain instances, some modifications of the global protocol may be permitted. For example, in countries where prospective monitoring of off-label antihistamines is prohibited, cohort 1 will not be enrolled.

Conditions

• Chronic Spontaneous Urticaria

Timeline

• Start date: 2026-02-02
• Primary completion: 2031-10-30
• Completion: 2031-10-30
• First posted: 2026-01-22
• Last updated: 2026-04-16

Locations

1 site across 1 country: United States