Novartis: Chronic Urticaria trials

The registry lists 38 Chronic Urticaria studies with Novartis as lead sponsor. 8 are open to participants now and 19 have results posted.

Phase 1 1Phase 2 8Phase 3 16Phase 4 1No phase 12(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Remibrutinib in Real-world Clinical Practice - a South Korea Sub-StudyNot yet recruitingNCT07920315
• Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 WeeksRecruitingNCT07816328Phase 3
• Remibrutinib in Real-world Clinical Practice - a Germany Sub-study (REASSERT)RecruitingNCT07642557
• A Real-world Study of Remibrutinib in Chronic Spontaneous Urticaria PatientsRecruitingNCT07408219
• Remibrutinib in Real-world Clinical Practice - a US Sub-studyRecruitingNCT07358780
• Remibrutinib in Real-world Clinical PracticeRecruitingNCT07358364
• Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic UrticariaRecruitingNCT06865651Phase 2
• Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous UrticariaAvailableNCT05170724
• 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.CompletedNCT05795153Phase 3Results posted
• A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistaminesCompletedNCT05048342Phase 3Results posted
• A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistaminesCompletedNCT05032157Phase 3Results posted
• A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1 AntihistaminesCompletedNCT05030311Phase 3Results posted
• Study of Efficacy and Safety of Ligelizumab in Chronic Spontaneous Urticaria Patients Who Completed a Previous Study With LigelizumabTerminatedNCT04210843Phase 3Results posted
• An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSUCompletedNCT04109313Phase 2Results posted
• This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistaminesCompletedNCT03926611Phase 2Results posted
• A Safety and Efficacy Study of Ligelizumab in the Treatment of CSU in Japanese Patients Inadequately Controlled With H1- AntihistaminesCompletedNCT03907878Phase 3Results posted
• A Phase III Study of Safety and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistaminesCompletedNCT03580369Phase 3Results posted
• A Phase III Study of and Efficacy of Ligelizumab in the Treatment of CSU in Adolescents and Adults Inadequately Controlled With H1-antihistamines.CompletedNCT03580356Phase 3Results posted
• Study to Investigate the Efficacy and Safety of QGE031 in Adolescent Patients With Chronic Spontaneous Urticaria (CSU)CompletedNCT03437278Phase 2Results posted
• Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous UrticariaCompletedNCT03328897Phase 3Results posted
• A Safety Extension Study to Evaluate the Long-term Safety of QGE031 in Chronic Spontaneous Urticaria (CSU) PatientsCompletedNCT02649218Phase 2Results posted
• Omalizumab in Chronic Spontaneous Urticaria Patients Non Responding to Initial Standard antihistaminE TreatmentCompletedNCT02550106Phase 4Results posted
• Dose-finding Study of QGE031 as add-on Therapy to Evaluate Efficacy and Safety in Patients With CSUCompletedNCT02477332Phase 2Results posted
• OPTIMA: Efficacy of Optimized Re-treatment and Step-up Therapy With Omalizumab in Chronic Spontaneous Urticaria (CSU) PatientsCompletedNCT02161562Phase 3Results posted
• Impact of Omalizumab on Quality of Life Measures and Angioedema Occurrence in Patients With CSU Refractory to TherapyCompletedNCT01723072Phase 3Results posted
• Mode of Action Study of Omalizumab in Patients With Chronic Idiopathic Urticaria (CIU) Who Fail to Respond to Antihistamine TreatmentCompletedNCT01599637Phase 2Results posted
• Efficacy and Safety of Omalizumab in Adults (18-70 Years) With Moderate to Severe Chronic UrticariaCompletedNCT00481676Phase 2Results posted
• A Real-World Study of Omalizumab Treatment Patterns in Chronic Urticaria Patients in ChinaCompletedNCT07450170
• A Study to Compare Digital Disease Monitoring of Patients With csU (Telemedicine to Face-to-Face Visits) in GermanyActive, not recruitingNCT06991608
• A Study to Evaluate Efficacy of Remibrutinib Compared to Dupilumab at Early Timepoints in Adults With Chronic Spontaneous Urticaria Inadequately Controlled by Second Generation H1-antihistaminesActive, not recruitingNCT06868212Phase 3
• A Real-world Study to Assess Safety and Effectiveness of Xolair® in Pediatric Chronic Spontaneous Urticaria in ChinaCompletedNCT06053801
• Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.Active, not recruitingNCT06042478Phase 3
• 24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-upActive, not recruitingNCT05677451Phase 3
• An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With RemibrutinibActive, not recruitingNCT05513001Phase 3
• Global Managed Access Program Cohort for Ligelizumab in CSUNo longer availableNCT04903613
• Study of Mechanism of Action of Ligelizumab (QGE031) in Patients With Chronic UrticariaTerminatedNCT04513548Phase 1
• A Worldwide Antihistamine-Refractory Chronic Urticaria Patient Evaluation in Latin America and Canada (AWARE-LACan)CompletedNCT02626221
• AWARE - Chronic UrticariaCompletedNCT02435238