A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Summary
This is a Phase 3, parallel group, placebo-controlled, double-blind, confirmatory study in patients with CINDU, with an optional Open-label Extension (OLE). The purpose of the core period (52 weeks of treatment) of this study is to evaluate the efficacy, safety, and tolerability of remibrutinib (LOU064) vs. placebo in adults suffering from CINDU inadequately controlled by H1-antihistamines (H1-AHs). The purpose of the OLE period is to collect long-term efficacy, safety, and tolerability data on remibrutinib in participants after having completed the Core period
Timeline
- Start
- 2023-12-07
- Primary completion
- 2026-05-11
- Completion
- 2029-06-15
Outcome
Met primary endpoint
release “Positive topline results from the pivotal Phase III RemIND trial showed oral remibrutinib met its primary endpoint in chronic inducible urticaria (CIndU)” novartis.com ↗
release “data from the RemIND trial at the European Academy of Allergy and Clinical Immunology (EAACI) Congress showing that Rhapsido ® (remibrutinib) met its primary endpoints” novartis.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remibrutinib | Small molecule | — | Oral |