Remibrutinib Meets Primary Endpoints in Phase 3 Trial for Chronic Inducible Urticaria Subtypes

Novartis has announced positive topline results from the pivotal phase 3 RemIND trial evaluating remibrutinib in chronic inducible urticaria (CIndU).¹ The study met its primary endpoint across the 3 most prevalent CIndU subtypes—symptomatic dermographism, cold urticaria, and cholinergic urticaria—demonstrating statistically significant and clinically meaningful complete response rates compared with placebo at week 12. These findings position remibrutinib as the first therapy to achieve a phase 3 primary endpoint in CIndU and highlight its potential to become the first targeted treatment approved for this indication.

Background

CIndU is a form of chronic urticaria characterized by reproducible wheals and/or angioedema triggered by specific external stimuli, such as friction, cold, heat, or exertion. Unlike chronic spontaneous urticaria (CSU), where triggers are not identifiable, patients with CIndU experience predictable symptom flares that can substantially impair daily functioning and quality of life. Despite affecting an estimated 29 million adults worldwide, treatment options for CIndU have remained limited, with most patients relying on non-sedating H1-antihistamines that often provide incomplete or inconsistent symptom control. Until now, no targeted therapies have been approved for this condition.

Remibrutinib is a highly selective, oral Bruton’s tyrosine kinase (BTK) inhibitor designed to block signaling pathways involved in mast cell activation and histamine release, a central driver of urticaria pathophysiology. By directly inhibiting BTK, remibrutinib aims to suppress downstream inflammatory cascades responsible for wheal formation and pruritus. As of September 2025, the drug is approved in the US for adult patients with CSU inadequately controlled by H1-antihistamines and is under investigation across a broader immunology and allergy pipeline.²

Trial Design & Results

The RemIND trial (NCT05976243) was a global, multicenter, randomized, double-blind, placebo-controlled phase 3 study enrolling adults with CIndU whose disease remained inadequately controlled despite antihistamine therapy. The primary endpoint was the proportion of complete responders at week 12, assessed using standardized provocation tests tailored to each CIndU subtype. Achieving complete response required the absence of wheals and symptoms upon exposure to the relevant trigger, a stringent and clinically meaningful measure of disease control.

Across all 3 evaluated subtypes (symptomatic dermographism, cold urticaria, and cholinergic urticaria), remibrutinib achieved significantly higher complete response rates than placebo. Importantly, complete responses were observed consistently across these mechanistically distinct forms of inducible urticaria, underscoring the central role of BTK-mediated mast cell activation across CIndU subtypes.

In addition to efficacy, remibrutinib demonstrated a favorable safety and tolerability profile in the RemIND trial. The drug was generally well tolerated, with no liver safety concerns reported—an important consideration given historical challenges with systemic therapies in chronic urticaria. The overall safety findings were consistent with previously reported data in CSU.

Next Steps

“The positive RemIND trial results across three different types of CIndU underscore the potential of oral remibrutinib to achieve complete symptom relief for people living with CIndU and build on its recent FDA approval in chronic spontaneous urticaria (CSU),” said Angelika Jahreis, Global Head of Immunology Development at Novartis. “Today’s findings reinforce that remibrutinib could be the first targeted therapy to improve spontaneous and inducible forms of chronic urticaria, helping address a major gap in care for people living with these conditions.”¹

Based on these results, Novartis has submitted a supplemental New Drug Application to the US Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism, the most common form of CIndU. The company has indicated that the full RemIND data set will be submitted to regulatory authorities globally and presented at upcoming scientific congresses, further informing clinical practice. If approved, remibrutinib would represent the first targeted therapy for chronic inducible urticaria, addressing a longstanding unmet need for patients who have few effective options beyond antihistamines.

References

1. Novartis remibrutinib first therapy to achieve Phase III primary endpoint in chronic inducible urticaria (CIndU). News release. Globe Newswire. Published February 18, 2026. Accessed February 18, 2026. https://www.globenewswire.com/news-release/2026/02/18/3239915/0/en/Novartis-remibrutinib-first-therapy-to-achieve-Phase-III-primary-endpoint-in-chronic-inducible-urticaria-CIndU.html

2. Novartis receives FDA approval for Rhapsido (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU). News release. Novartis. September 30, 2025. Accessed February 18, 2025. https://www.globenewswire.com/news-release/2025/09/30/3159065/0/en/Novartis-receives-FDA-approval-for-Rhapsido-remibrutinib-the-only-oral-targeted-BTKi-treatment-for-chronic-spontaneous-urticaria-CSU.html