Cholinergic urticaria is a type of hives triggered by increases in body temperature from exercise, stress, hot showers, or spicy foods. It typically causes small, itchy wheals and can sometimes be accompanied by burning or stinging sensations.
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 |
|---|---|---|---|
| NCT06948188 |
Identification of Subpopulations of Patients With Cholinergic Urticaria Based on Infrared Exposure Test Results. |
NOT_YET_RECRUITING | NA |
| NCT06201780 |
Assessment of Serum Levels of Janus Kinase 1 and 2 in Patients With Cholinergic Urticaria |
RECRUITING | NA |
| NCT04853992 |
Trial to Assess the Efficacy and Safety of LEO 152020 in Adult Patients With Cholinergic Urticaria |
COMPLETED | PHASE2 |
| NCT04548869 |
A Single Dose Study of the Safety, Pharmacokinetics and Pharmacodynamics of CDX-0159 in Patients With Cold Contact Urticaria, Symptomatic Dermographism, or Cholinergic Urticaria |
COMPLETED | PHASE1 |
| NCT04513548 |
Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic Urticaria |
TERMINATED | PHASE1 |
| NCT03749148 |
Cholinergic Urticaria - Efficacy of Dupilumab |
COMPLETED | PHASE2 |
| NCT02012387 |
Efficacy Study of Omalizumab in Cholinergic Urticaria |
COMPLETED | PHASE2 |
