Novartis has announced positive topline results from its pivotal Phase III RemIND trial evaluating oral remibrutinib in chronic inducible urticaria (CIndU), marking the first time a therapy has met a Phase III primary endpoint in the condition.
The RemIND study met its primary endpoint across the three most prevalent forms of CIndU — symptomatic dermographism, cold urticaria and cholinergic urticaria — with significantly higher complete response rates at Week 12 compared with placebo. The results suggest remibrutinib could become the first targeted therapy approved specifically for CIndU, a chronic skin disorder estimated to affect around 29 million adults globally.
Remibrutinib is a highly selective oral Bruton’s tyrosine kinase (BTK) inhibitor designed to block a key pathway involved in histamine release, which drives the development of hives and swelling. By reducing histamine release, the therapy aims to relieve hallmark symptoms such as wheals and angioedema. In the trial, the drug was reported to be well tolerated and demonstrated a favourable safety profile, with no liver safety concerns identified.
Chronic inducible urticaria is characterised by recurrent hives and/or swelling triggered by specific external stimuli, including pressure, friction, cold, heat or sunlight. It differs from chronic spontaneous urticaria, which occurs without identifiable triggers. The most common subtypes include symptomatic dermographism, in which friction or light scratching induces itchy hives within minutes; cold urticaria, triggered by exposure to low temperatures; and cholinergic urticaria, associated with increased body temperature from exercise, emotional stress or hot showers.
Patients with CIndU often cycle through H1-antihistamines with limited symptom control, and no targeted therapies are currently approved for the condition. The unmet need has been compounded by the disorder’s impact on quality of life, as unpredictable flare-ups can interfere with daily activities and social functioning.
The global, multicentre, randomised, double-blind, placebo-controlled RemIND trial enrolled adults whose disease was inadequately controlled by H1-antihistamines. The primary endpoint assessed the proportion of complete responders at Week 12 using provocation tests tailored to each CIndU subtype.
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 plans to submit the full dataset to additional health authorities in the coming months and present detailed findings at upcoming medical congresses.
Remibrutinib is already approved in the United States and China under the brand name Rhapsido for adults with chronic spontaneous urticaria who do not respond adequately to antihistamines.
Beyond urticaria, the therapy is being investigated in other immune-mediated conditions, including hidradenitis suppurativa and food allergy, as part of the company’s broader immunology and neuroscience pipeline.
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