Cold urticaria is a rare inducible urticaria in which exposure to cold temperatures triggers itchy wheals/hives and sometimes systemic reactions. Symptoms can be mild or severe and may include dangerous reactions during cold-water exposure.
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 |
|---|---|---|---|
| NCT07266402 |
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD) |
RECRUITING | PHASE3 |
| NCT07181369 |
A Phase 1 Study of GTX-B001 in Healthy Subjects and Patients With Chronic Inducible Urticaria |
RECRUITING | PHASE1 |
| NCT05960708 |
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases |
COMPLETED | PHASE1 |
| NCT04681729 |
Dupilumab for the Treatment of Chronic Inducible Cold Urticaria in Patients Who Remain Symptomatic Despite the Use of H1-antihistamine (LIBERTY-CINDU CUrIADS) |
COMPLETED | PHASE3 |
| 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 |
