drugset / Trial / NCT03926611

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

NCT03926611

Phase 2 Completed 311 enrolled Novartis Pharmaceuticals
RandomizedParallel-groupTriple-blindTreatment

Summary

This was a multicenter, randomized, double-blind and placebo-controlled phase 2b dose-finding study to assess the efficacy and safety of LOU064 in adults chronic spontaneous urticaria (CSU) patients inadequately controlled by H1-antihistamines

Timeline

Start
2019-06-06
Primary completion
2021-01-14
Completion
2021-04-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Remibrutinib Small molecule 10 mg Oral
Subject Remibrutinib Small molecule 25 mg Oral
Subject Remibrutinib Small molecule 35 mg Oral
Subject Remibrutinib Small molecule 100 mg Oral