Product
LOU064
Aliases
LOU064 (blinded), LOU064 (open-label), Part 1; LOU064 (Remibrutinib), remibrutinib
9 clinical trials
3 indications
Indication
Chronic Spontaneous UrticariaIndication
Liver ImpairmentIndication
Hidradenitis SuppurativaClinical trial
A Phase 1, Open-label, Study to Investigate the Pharmacokinetics and Safety of Remibrutinib (LOU064) in Participants With Hepatic Impairment Compared to Matched Healthy Participants With Normal Hepatic FunctionStatus: Completed, Estimated PCD: 2023-12-14
Clinical trial
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistaminesStatus: Completed, Estimated PCD: 2023-12-07
Clinical trial
A Multicenter, Open-label Phase 3 Study of Remibrutinib (LOU064) to Investigate the Safety, Tolerability and Efficacy for 52 Weeks in Adult Japanese Chronic Spontaneous Urticaria Patients Inadequately Controlled by H1-antihistaminesStatus: Completed, Estimated PCD: 2023-12-08
Clinical trial
A Multicenter, Open-label Phase 3 Study: Ambulatory Blood Pressure Monitoring in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Treated With Remibrutinib up to 12 Weeks.Status: Active (not recruiting), Estimated PCD: 2024-04-25
Clinical trial
A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal and Open-label Extension Study Followed by Long-term Open-label Treatment Cycles to Assess the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Chronic Spontaneous Urticaria Patients Who Completed the Preceding Remibrutinib Phase 3 StudiesStatus: Recruiting, Estimated PCD: 2027-07-01
Clinical trial
An Open-label, Multicenter, Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Eligible Subjects With CSU Who Have Participated in CLOU064A2201Status: Completed, Estimated PCD: 2022-09-09
Clinical trial
A Randomized, Subject and Investigator Blinded, Placebo-controlled and Multi-center Platform Study, to Assess Efficacy and Safety of Different Investigational Drugs in Patients With Moderate to Severe Hidradenitis SuppurativaStatus: Recruiting, Estimated PCD: 2024-11-22
Clinical trial
A Double-blind, Randomized, Placebo-controlled Trial to Evaluate the Efficacy, Pharmacokinetics and Safety of Remibrutinib (LOU064) for 24 Weeks in Adolescents From 12 to Less Than 18 Years of Age With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Followed by an Optional Open-label Extension for up to Another 3 Years and an Optional Safety Long-term Treatment-free Follow-up Period for up to an Additional 3 YearsStatus: Recruiting, Estimated PCD: 2025-11-21
Clinical trial
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study of Remibrutinib (LOU064) to Investigate the Efficacy, Safety and Tolerability for 52 Weeks in Adult Chronic Spontaneous Urticaria (CSU) Patients Inadequately Controlled by H1-antihistaminesStatus: Completed, Estimated PCD: 2023-12-27