Novartis Remibrutinib Achieves Phase III Endpoint in Chronic Inducible Urticaria

Novartis reported that the phase 3 RemIND trial of oral remibrutinib achieved its primary endpoint in the three most prevalent types of chronic inducible urticaria (CIndU). Complete response rates at week 12 were significantly higher with remibrutinib versus placebo for the three CIndU types.

In the double-blind, placebo-controlled RemIND trial (ClinicalTrials.gov Identifier: NCT05976243), adults with CIndU inadequately controlled by H1 antihistamines (N=364) were randomly assigned to receive remibrutinib or placebo twice daily. The primary endpoint was the proportion of participants achieving a complete response at week 12, assessed through provocation tests specific to 3 CIndU subtypes: Total Fric Score (symptomatic dermographism), critical temperature threshold (cold urticaria), or itch numerical rating scale (cholinergic urticaria).

Remibrutinib was found to be safe and well tolerated, with no liver safety concerns. Unlike chronic spontaneous urticaria (CSU), chronic inducible urticaria is known to have specific triggers such as pressure, sunlight, friction, heat, cold, or water.

The Company has submitted a supplemental New Drug Application to the Food and Drug Administration seeking approval of remibrutinib for the treatment of symptomatic dermographism, the most common type of CIndU. FDA submission for remibrutinib in symptomatic dermographism was completed in Q4 2025.

Full results will be submitted to regulatory authorities globally, and the RemIND trial findings will be presented at upcoming medical congresses.

Remibrutinib is an oral, small molecule Bruton tyrosine kinase inhibitor approved under the brand name Rhapsido® for the treatment of chronic spontaneous urticaria in adult patients who remain symptomatic despite H1 antihistamine treatment.

Novartis will present data from five key abstracts evaluating remibrutinib in chronic spontaneous urticaria and as an investigational therapy for peanut allergy at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting in Philadelphia, PA, from February 27 to March 2, 2026. New analyses on the impact of Rhapsido on disease control and early symptom relief from the Phase III REMIX-1 and REMIX-2 trials in CSU will be presented. Additionally, the first presentation of Phase II food allergy data for remibrutinib, focusing on IgE‑mediated peanut allergy, will be featured in an oral session.

Plans are in progress to begin the Phase III program in food allergy in 2026. In addition to food allergy, remibrutinib is in clinical development for chronic inducible urticaria and hidradenitis suppurativa. Regulatory reviews for remibrutinib for the treatment of CSU are underway in several regions, including the European Union and Japan.