Novartis Remibrutinib Shows Phase III Success in CIndU

Novartis has announced positive topline results from its pivotal Phase III RemIND trial evaluating oral remibrutinib in patients with chronic inducible urticaria (CIndU), a condition marked by recurrent hives and swelling triggered by specific external stimuli. The company said the study met its primary endpoint across the three most prevalent forms of CIndU—symptomatic dermographism, cold urticaria, and cholinergic urticaria—demonstrating significantly higher complete response rates compared with placebo at Week 12.

The RemIND trial (NCT05976243) is a global, multicenter, randomized, double-blind, placebo-controlled study assessing the efficacy, safety, and tolerability of remibrutinib in adults whose symptoms remain inadequately controlled by H1-antihistamines. The primary endpoint measured the proportion of complete responders at Week 12 using provocation tests specific to each subtype.

CIndU affects an estimated 0.5 percent of the global population—approximately 29 million people worldwide—and is characterized by hives and/or angioedema triggered by factors such as pressure, friction, heat, cold, sunlight, or water. Unlike chronic spontaneous urticaria (CSU), which occurs without identifiable triggers, CIndU episodes are reproducible following exposure to certain stimuli. Despite its significant impact on daily life, there are currently no approved targeted therapies specifically for CIndU, leaving many patients cycling through antihistamines without adequate symptom relief.

Angelika Jahreis, Global Head of Immunology Development at Novartis, said the positive findings across three CIndU subtypes highlight the potential of oral remibrutinib to provide complete symptom relief. She noted that the data build on the therapy’s recent U.S. approval in chronic spontaneous urticaria under the brand name Rhapsido® for adults who do not respond adequately to H1-antihistamines. According to Jahreis, the results reinforce remibrutinib’s potential to become the first targeted therapy addressing both spontaneous and inducible forms of chronic urticaria.

Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor designed to block the BTK pathway involved in histamine release—a central driver of wheals and swelling. By reducing histamine release, the therapy aims to control symptoms more effectively than standard antihistamines alone.

Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking approval of remibrutinib for symptomatic dermographism, the most common CIndU subtype. The company plans to present full trial data at upcoming medical congresses and submit additional regulatory filings globally in the coming months.

If approved, remibrutinib could mark a significant advancement in addressing a longstanding treatment gap for patients living with chronic inducible urticaria.