Remibrutinib Maintains Efficacy Through Week 52 in Phase III CIndU Trial
Key Takeaways
Phase III RemIND data showed sustained responses to Rhapsido (remibrutinib) through 52 weeks in patients with chronic inducible urticaria (CIndU).
At Week 52, complete or partial response rates ranged from 46.8% to 83.3% across three CIndU subtypes among patients initially assigned to remibrutinib.
Novartis reported a safety profile consistent with previous studies and plans additional regulatory submissions for CIndU.
Novartis announced new 52-week Phase III RemIND results showing sustained efficacy of Rhapsido (remibrutinib) in patients with chronic inducible urticaria (CIndU), including symptomatic dermographism (SD), cold urticaria (ColdU), and cholinergic urticaria (CholU).
The findings, announced by Novartis on November 12, 2026, will be foirmally presented as a late-breaking abstract at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting.
Investigators for the RemIND program evaluated remibrutinib 25 mg twice daily across three CIndU subtypes. Patients initially randomized to remibrutinib maintained treatment responses through Week 52, while those switching from placebo to remibrutinib at Week 24 achieved similar response rates by Week 52.
RemIND Phase III Results Across Chronic Inducible Urticaria Subtypes
At Week 1, complete or partial responses on subtype-specific provocation tests occurred in 41.8% of remibrutinib-treated patients vs 19.2% receiving placebo in the SD cohort, and 67.4% vs 28.9%, respectively, in the ColdU cohort. At Week 2, response rates in the CholU cohort were 65.2% with remibrutinib vs 45.6% with placebo.
By Week 52, response rates among patients initially randomized to remibrutinib were 46.8% for SD, 83.3% for ColdU, and 58.2% for CholU. Corresponding rates among patients switching from placebo at Week 24 were 47.7%, 88.9%, and 69.8%.
Novartis reported that remibrutinib was well tolerated through Week 52, with a safety profile consistent with previous studies and experience in chronic spontaneous urticaria.
Source
Novartis news release. November 12, 2026.