Novartis has announced positive topline results from its pivotal Phase III RemIND trial evaluating oral remibrutinib in adults with chronic inducible urticaria (CIndU), a condition marked by hives and swelling triggered by specific external stimuli.

The study met its primary endpoint across the three most prevalent CIndU subtypes—symptomatic dermographism, cold urticaria and cholinergic urticaria—demonstrating significantly higher complete response rates compared to placebo at Week 12. The findings highlight remibrutinib’s potential to become the first targeted therapy for CIndU, addressing a longstanding unmet medical need.

“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, Immunology Development, Novartis. “These findings reinforce that remibrutinib could be the first targeted therapy to improve both spontaneous and inducible forms of chronic urticaria.”

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. Full data from the RemIND trial will be presented at upcoming medical congresses and submitted to global regulatory authorities.

Remibrutinib is a highly selective, oral Bruton's Tyrosine Kinase (BTK) inhibitor that blocks the BTK pathway responsible for histamine release—a key driver of hives and swelling. By reducing histamine release, the therapy aims to provide sustained symptom control.

In the United States and China, remibrutinib is already approved under the brand name Rhapsido for adults with chronic spontaneous urticaria who have an inadequate response to H1-antihistamines.

The global Phase III RemIND study is a randomised, double-blind, placebo-controlled trial assessing the efficacy, safety and tolerability of remibrutinib in adults whose CIndU remains inadequately controlled with antihistamines. The primary endpoint evaluated the proportion of complete responders at Week 12 using provocation tests specific to each subtype.

CIndU affects an estimated 29 million people worldwide and is characterised by hives and/or swelling triggered by factors such as pressure, friction, cold, heat or sunlight. Unlike chronic spontaneous urticaria, which has no identifiable triggers, CIndU significantly disrupts daily life and often remains poorly controlled with standard antihistamines. Currently, no targeted therapies are approved specifically for CIndU.