Novartis’ Rhapsido Delivers Positive Phase 3 Results in CIU

Novartis reported positive Phase 3 results from the global RemIND trial (NCT05976243), with Rhapsido® (remibrutinib) achieving significantly higher complete response rates than placebo across symptomatic dermographism, cold urticaria, and cholinergic urticaria. Presented at the 2026 European Academy of Allergy and Clinical Immunology (EAACI) Congress, the findings mark the first time a therapy has demonstrated efficacy in a Phase 3 program spanning multiple chronic inducible urticaria (CIndU) subtypes.

The results position Rhapsido as a potential first targeted treatment for CIndU, an area where no approved targeted therapies currently exist despite substantial patient burden and limited treatment options.

Clinical Outcomes

The randomized, double-blind, placebo-controlled study enrolled adults with CIndU whose disease remained inadequately controlled despite treatment with second-generation H1-antihistamines. The primary endpoint was the proportion of patients achieving complete response at Week 12 using subtype-specific provocation tests.

At Week 12, complete response rates were markedly higher with Rhapsido than placebo across all three major CIndU subtypes. In symptomatic dermographism, 29.3% of patients achieved complete response compared with 14.0% receiving placebo. In cold urticaria, complete response rates reached 56.3% versus 14.6%, while in cholinergic urticaria the rates were 29.3% and 15.8%, respectively.

Responses emerged as early as Week 2 in two of the three subtypes, highlighting the potential for rapid symptom control. Investigators also reported a favorable safety profile, with no observed liver safety concerns during the study.

Disease Burden and Unmet Need

CIndU affects an estimated 29 million people worldwide and is triggered by specific physical or environmental stimuli such as friction, pressure, cold exposure, heat, exercise, or sunlight. Unlike chronic spontaneous urticaria (CSU), symptoms occur following identifiable triggers and can significantly disrupt daily activities, sleep, work productivity, and overall quality of life.

More than half of patients continue to experience substantial disease burden despite treatment with H1-antihistamines. As no targeted therapies are currently approved for CIndU, a significant unmet medical need remains across all major subtypes.

Mechanism of Action

Rhapsido is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor administered at a dose of 25 mg twice daily. The therapy blocks BTK signaling pathways involved in histamine release from mast cells and basophils, key drivers of wheals, itching, and swelling in chronic urticaria.

By reducing histamine-mediated inflammation, Rhapsido helps control disease symptoms and has already demonstrated efficacy and a favorable safety profile in patients with chronic spontaneous urticaria. The RemIND findings extend that clinical evidence into inducible forms of the disease.

Clinical Implications

Martin Metz, MD, Deputy Director of the Institute of Allergology at Charité–Universitätsmedizin Berlin, said the efficacy observed across the three most common CIndU subtypes underscores the potential of Rhapsido to address a longstanding treatment gap for patients who remain symptomatic despite antihistamine therapy.

Angelika Jahreis, Global Head of Immunology Development at Novartis, noted that the findings are consistent with the established efficacy and safety profile of remibrutinib in CSU and support its potential to become the first targeted therapy available for chronic inducible urticaria.

Regulatory Path Forward

Novartis has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration seeking approval of Rhapsido for symptomatic dermographism, the most common CIndU subtype. Additional regulatory submissions to health authorities worldwide are planned throughout 2026.

Rhapsido is already approved in the United States, European Union, China, South Korea, and several other markets for adults with chronic spontaneous urticaria who remain inadequately controlled on H1-antihistamines.

If approved for symptomatic dermographism and additional CIndU subtypes, Rhapsido could become the first targeted therapy available for chronic inducible urticaria, addressing a longstanding treatment gap for patients whose symptoms remain inadequately controlled with existing treatment options.

Reference

Novartis RemIND data at EAACI show Rhapsido® potential as first targeted therapy for chronic inducible urticaria (CIndU) | Novartis