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Remibrutinib

DRUG12 trials

Sponsors

Novartis Pharmaceuticals

Conditions

Autoimmune and Chronic Inflammatory DiseasesChronic Inducible UrticariaChronic Pruritus of Unknown OriginChronic Spontaneous UrticariaChronic Spontaneous Urticaria (CSU)Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)Hidradenitis SuppurativaIndication of the Parent Protocol

Phase 1

Phase 2

Phase 3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Active, not recruitingNCT05147220
Novartis PharmaceuticalsRelapsing Multiple Sclerosis
Start: 2021-12-16End: 2030-10-30Updated: 2026-05-29
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Active, not recruitingNCT05156281
Novartis PharmaceuticalsRelapsing Multiple Sclerosis
Start: 2021-12-13End: 2030-10-30Updated: 2026-06-24
A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines
Active, not recruitingNCT05976243
Novartis PharmaceuticalsChronic Inducible Urticaria
Start: 2023-12-07End: 2029-06-15Updated: 2026-06-08
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 recruitingNCT06042478
Novartis PharmaceuticalsChronic Spontaneous Urticaria
Start: 2023-11-15End: 2027-07-20Updated: 2026-06-03
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-antihistamines
RecruitingNCT06868212
Novartis PharmaceuticalsChronic Spontaneous Urticaria (CSU)
Start: 2025-07-11End: 2027-05-17Target: 400Updated: 2026-07-10
Remibrutinib Open Label Roll-over Post-trial Access Protocol
RecruitingNCT07456891
Novartis PharmaceuticalsIndication of the Parent Protocol
Start: 2026-04-16End: 2033-01-30Target: 648Updated: 2026-07-08
An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS
RecruitingNCT07665437
Novartis PharmaceuticalsHidradenitis Suppurativa
Start: 2026-07-10End: 2031-10-27Target: 710Updated: 2026-07-15
A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)
Not yet recruitingNCT07700056
Novartis PharmaceuticalsChronic Pruritus of Unknown Origin
Start: 2026-08-14End: 2030-04-15Target: 180Updated: 2026-07-13

Unknown Phase

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