Chronic spontaneous urticaria (CSU) is a mast cell-mediated skin disorder with recurrent hives and/or angioedema lasting at least 6 weeks without a specific external trigger. It can significantly affect sleep, function, and quality of life.
Two studies examined blood biomarkers for omalizumab response in chronic spontaneous urticaria. Basophil histamine content did not predict response, while higher baseline monocyte counts were linked to complete remission in a 52-patient retrospective analysis.
Novartis received EU approval for Rhapsido (remibrutinib) as the first oral targeted treatment for chronic spontaneous urticaria. Phase 3 data also showed significant efficacy in chronic inducible urticaria, with filings underway for additional indications.
Novartis announced positive European regulatory opinion for remibrutinib in chronic spontaneous urticaria and reported the drug met its primary endpoint in a Phase 3 trial for chronic inducible urticaria.
Novartis announced positive topline results from its Phase III RemIND trial of remibrutinib in chronic inducible urticaria, meeting the primary endpoint for the three most prevalent types of the condition with significantly higher complete response rates versus placebo.
Novartis announced positive topline results from its Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint across three prevalent subtypes with significantly higher complete response rates versus placebo at Week 121.
Novartis announced positive Phase III RemIND trial results for oral remibrutinib in chronic inducible urticaria, marking the first therapy to meet a Phase III primary endpoint in the condition. The company has submitted a supplemental New Drug Application to the FDA.
Novartis reported positive Phase III RemIND trial results showing remibrutinib achieved complete response in three types of chronic inducible urticaria. The company has submitted a supplemental New Drug Application to the FDA for symptomatic dermographism.
Novartis announced positive topline results from its pivotal Phase III RemIND trial of oral remibrutinib in chronic inducible urticaria, meeting the primary endpoint for three prevalent CIndU types with significantly higher complete response rates versus placebo at Week 12.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
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RECRUITING | |
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