Remibrutinib

DRUG16 trials

Sponsors

Novartis Pharmaceuticals, Washington University School of Medicine

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)Cow Milk AllergyEgg Allergy

Phase 1

A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants.

CompletedNCT07032272

Novartis PharmaceuticalsAutoimmune and Chronic Inflammatory Diseases

Start: 2025-07-23End: 2025-10-14Updated: 2026-03-30

Phase 2

A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome

TerminatedNCT04035668

Novartis PharmaceuticalsSjögren Syndrome

Start: 2019-07-12End: 2021-11-23Updated: 2023-01-30

Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria

RecruitingNCT06865651

Novartis PharmaceuticalsChronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)

Start: 2025-05-22End: 2027-09-28Target: 44Updated: 2026-09-09

Phase 3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)

Active, not recruitingNCT05147220

Novartis PharmaceuticalsRelapsing Multiple Sclerosis

Start: 2021-12-16End: 2030-10-30Updated: 2026-08-18

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)

Active, not recruitingNCT05156281

Novartis PharmaceuticalsRelapsing Multiple Sclerosis

Start: 2021-12-13End: 2030-10-30Updated: 2026-08-18

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: 2026-08-20

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: 2026-08-19

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: 2026-08-19

Remibrutinib Open Label Roll-over Post-trial Access Protocol

RecruitingNCT07456891

Novartis PharmaceuticalsIndication of the Parent Protocol

Start: 2026-04-16End: 2033-01-30Target: 648Updated: 2026-09-09

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: 2031-10-24Target: 710Updated: 2026-09-04

A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

RecruitingNCT07700056

Novartis PharmaceuticalsChronic Pruritus of Unknown Origin

Start: 2026-08-24End: 2030-04-15Target: 180Updated: 2026-09-09

A 52-week Study of Remibrutinib in IgE-mediated Food Allergy

RecruitingNCT07768371

Novartis PharmaceuticalsCow Milk Allergy, Egg Allergy, IgE-Mediated Food Allergy +1

Start: 2026-08-27End: 2029-12-31Target: 576Updated: 2026-09-09

A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO)

RecruitingNCT07811869

Novartis PharmaceuticalsChronic Pruritus of Unknown Origin

Start: 2026-10-06End: 2030-01-03Target: 180Updated: 2026-09-10

Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks

Not yet recruitingNCT07816328

Novartis PharmaceuticalsChronic Spontaneous Urticaria

Start: 2026-11-09End: 2028-07-17Target: 382Updated: 2026-09-11

Unknown Phase

Global Managed Access Program Cohort for Remibrutinib in Adult Patients With Chronic Spontaneous Urticaria

Novartis PharmaceuticalsChronic Spontaneous Urticaria

Updated: 2025-12-05

Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis.

RecruitingNCT07758270

Washington University School of MedicineMultiple Sclerosis (MS) - Relapsing-remitting

Start: 2026-08-15End: 2030-08-29Target: 15Updated: 2026-08-11

Related Papers

Efficacy of Remibrutinib versus Dupilumab at Early Timepoints in Chronic Spontaneous Urticaria: US Phase 3b Study Design (RECLAIM)

Dermatology and Therapy2026-03-19

The Bruton’s Tyrosine Kinase Inhibitor Remibrutinib Exhibits No Impact on Serum Immunoglobulin Levels: Insights from Chronic Spontaneous Urticaria (P10-6.018)

Neurology2024-04-09

Efficacy and safety of remibrutinib, a selective potent oral BTK inhibitor, in Sjögren's syndrome: results from a randomised, double-blind, placebo-controlled phase 2 trial.

2024-02-1530 citations

Remibrutinib: A Novel BTKi in Development for MS With a Favorable Safety Profile in Various Autoimmune Disorders (P7-3.015)

Neurology2023-04-25