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

*Proportion of participants with complete response to FricTest® (TFS=0), TempTest® (CTT<4°C), or pulse-controlled ergometry test at week 12 (itch NRS score=0).

About Rhapsido^®
Rhapsido (remibrutinib) is a highly selective, oral BTK inhibitor that blocks the BTK pathway involved in the release of histamine, a key driver of hives (wheals) and swelling^9-11. By reducing histamine release, Rhapsido helps relieve the symptoms of CIndU^2,12. In the U.S., European Union, China, South Korea and several other countries, Rhapsido is approved for the treatment of adult patients with CSU who have an inadequate response to H1-antihistamines. Remibrutinib is being investigated in other immune-mediated conditions, such as hidradenitis suppurativa (HS) and food allergy, in addition to other indications in the company’s Neuroscience portfolio^13-16.

About the RemIND trial
The RemIND trial (NCT05976243) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study evaluating the efficacy, safety, and tolerability of Rhapsido in adults with CIndU inadequately controlled by H1-antihistamines¹⁷. The primary endpoint of RemIND is the proportion of complete responders at Week 12 assessed through provocation tests specific to three CIndU subtypes¹⁷. The secondary endpoints were change from baseline to the same endpoints at weeks 2 and 12; and the proportion of participants with complete response at weeks 2 and 24.

About Chronic Inducible Urticaria (CIndU)
CIndU is a chronic skin condition affecting an estimated 0.5 percent of the population or 29 million people worldwide^3,4. CIndU differs from chronic spontaneous urticaria (CSU), which has no specific triggers¹⁹. CIndU places a significant burden on daily life, with many patients cycling through antihistamines without adequate relief²⁰. With no approved targeted therapies available today, there remains a clear and longstanding gap in effective treatment options for these patients^20,21.

The most prevalent CIndU subtype, symptomatic dermographism, manifests with itchy hives caused by shear force on skin, such as friction or light scratching, which appear in less than 5 minutes after contact and usually last 30 minutes¹⁸. Cold urticaria occurs after skin exposure to cold, leading to wheals or angioedema that develop within minutes after exposure and are usually limited to exposed areas¹⁸. Cholinergic urticaria manifests with characteristic small, punctate hives triggered by active or passive heating of the body, including exercise, strong emotions, or bathing in hot water¹⁸.

About Novartis Immunology
At Novartis, we’re advancing bold science with the goal of bringing relief and a renewed sense of hope to people living with autoimmune diseases. Building on our legacy of first-in-class innovation across rheumatology, dermatology and allergy, and a diverse industry-leading pipeline, we’re committed to shaping what’s next in Immunology.

Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.

Disclaimer
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About Novartis 
Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide.

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