A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 Antihistamines
Summary
The purpose of this study was to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) in adult participants suffering from chronic spontaneous urticaria (CSU) inadequately controlled by H1-antihistamines in comparison to placebo.
Timeline
- Start
- 2021-11-30
- Primary completion
- 2023-12-27
- Completion
- 2024-01-19
Outcome
Met primary endpoint
paper The remibrutinib group had a significantly greater decrease in the UAS7 at week 12 than the placebo group PMID 40043237 ↗
registry analysis (superiority test); LOU064 25mg b.i.d. vs Placebo; p <0.001; Mean Difference (Final Values) -6.22 (95% CI -8.45 to -4.00) NCT05030311 ↗
registry analysis (superiority test); LOU064 25mg b.i.d. vs Placebo; p <0.001; Mean Difference (Final Values) -2.63 (95% CI -3.70 to -1.56) NCT05030311 ↗
registry analysis (superiority test); LOU064 25mg b.i.d. vs Placebo; p <0.001; Mean Difference (Final Values) -3.61 (95% CI -4.85 to -2.36) NCT05030311 ↗
release “The Phase III REMIX-1 and REMIX-2 studies met all primary and secondary endpoints, showing rapid, clinically meaningful improvements across urticaria disease activity scores” novartis.com ↗
Publications
- Mosnaim G, Saini S, Lebwohl M, Thomsen SF, Reed J, Yang B, Fukunaga A, Jain V, Field C, Kuruvilla M, Martzloff ED, Seko N, Wang P, Haemmerle S, Metz M. Remibrutinib impact on disease control, sleep, and quality of life: Analysis of phase 3 REMIX-1/2. Ann Allergy Asthma Immunol. 2026 Jun 15:S1081-1206(26)00271-1. doi: 10.1016/j.anai.2026.06.011. Online ahead of print.
- Metz M, Gimenez-Arnau A, Hide M, Lebwohl M, Mosnaim G, Saini S, Sussman G, Szalewski R, Haemmerle S, Lheritier K, Martzloff ED, Seko N, Wang P, Zharkov A, Maurer M; REMIX-1 and REMIX-2 Investigators; REMIX-1 Investigators; REMIX-2 Investigators. Remibrutinib in Chronic Spontaneous Urticaria. N Engl J Med. 2025 Mar 6;392(10):984-994. doi: 10.1056/NEJMoa2408792.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Remibrutinib | Small molecule | 25 mg | Oral |