Also known as: CIndU, CINDU
Chronic inducible urticaria is a subtype of chronic urticaria in which recurrent wheals and/or angioedema are triggered by specific physical or environmental stimuli such as pressure, heat, cold, sunlight, or vibration. Symptoms persist for at least 6 weeks and can significantly impair quality of life.
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 |
|---|---|---|---|
| NCT07540910 |
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Doses of EDP-978 in Healthy Adults |
RECRUITING | PHASE1 |
| 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 |
| NCT06931405 |
Study of BLU-808 in Chronic Inducible Urticaria (CIndU) and Chronic Spontaneous Urticaria (CSU) |
RECRUITING | PHASE2 |
| NCT06603220 |
A Study Evaluating the Safety, Tolerability, and Efficacy of EVO756 in Adults With Chronic Inducible Urticaria |
COMPLETED | PHASE2 |
| NCT06353971 |
A Dose Escalation Trial of Safety, Pharmacokinetic/Pharmacodynamic and Preliminary Clinical Activity of Briquilimab in Adult Patients With Chronic Inducible Urticaria (CIndU) Who Remain Symptomatic Despite Treatment With H1- Antihistamines |
TERMINATED | PHASE1/PHASE2 |
| NCT06050928 |
Phase 1b, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of EP262 in Subjects With Chronic Inducible Urticaria |
COMPLETED | PHASE1 |
| NCT05976243 |
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT05960708 |
A Single Dose, Phase 1 Study of YH35324 in Patients with Various Allergic Diseases |
COMPLETED | PHASE1 |
| NCT05405660 |
A Study of CDX-0159 in Patients With Chronic Inducible Urticaria |
COMPLETED | PHASE2 |
