12 recruiting, 10 active not recruiting, 10 completed, 2 terminated. 22 Phase 3, 8 Phase 2, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 22 | Active not recruiting 10, Recruiting 8, Completed 4 |
| Phase 2 | 8 | Completed 3, Recruiting 2, Terminated 2, Not yet recruiting 1 |
| Phase 1 | 4 | Completed 3, Recruiting 1 |
Follow remibrutinib: new trials by email Literature Review of remibrutinib trials Research Report on remibrutinib
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Study of Remibrutinib Using MR Imaging in Relapsing or Progressive MS Remibrutinib (Open Label) - Multiple Sclerosis (MS) - Relapsing-remitting, Multiple Sclerosis (MS) Secondary Progressive | Phase 2 | Not yet recruiting | Moein Amin | 20 | 2027-03-01 | 2026-08-19 |
| A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS LOU064, Placebo - Hidradenitis Suppurativa | Phase 1 | Recruiting | Novartis Pharmaceuticals | 30 | 2026-10-15 | 2026-10-16 |
| A Study to Evaluate Efficacy, Safety, and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO) Remibrutinib, Placebo - Chronic Pruritus of Unknown Origin | Phase 3 | Recruiting | Novartis Pharmaceuticals | 180 | 2026-10-07 | 2026-10-13 |
| Investigation of a Remibrutinib- and Omalizumab-based Treatment Algorithm in Adult Patients With Chronic Spontaneous Urticaria Inadequately Controlled by H1-antihistamines Within 24 Weeks Remibrutinib, Omalizumab - Chronic Spontaneous Urticaria | Phase 3 | Recruiting | Novartis Pharmaceuticals | 382 | 2026-09-21 | 2026-10-13 |
| A 52-week Study of Remibrutinib in IgE-mediated Food Allergy Remibrutinib, Placebo - IgE-Mediated Food Allergy, Peanut Allergy | Phase 3 | Recruiting | Novartis Pharmaceuticals | 576 | 2026-08-27 | 2026-10-13 |
| A Study to Evaluate Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With Severe Chronic Pruritus of Unknown Origin (CPUO) Remibrutinib, Placebo - Chronic Pruritus of Unknown Origin | Phase 3 | Recruiting | Novartis Pharmaceuticals | 180 | 2026-08-24 | 2026-10-13 |
| Brain Imaging and Immune Changes During Remibrutinib Treatment in Multiple Sclerosis. Remibrutinib, Ocrelizumab (US) - Multiple Sclerosis (MS) - Relapsing-remitting | Recruiting | Washington University School of Medicine | 15 | 2026-08-15 | 2026-08-11 | |
| A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR) LOU064, Placebo - Papulopustular Rosacea | Phase 2 | Recruiting | Novartis Pharmaceuticals | 100 | 2026-07-30 | 2026-10-15 |
| An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS Remibrutinib - Hidradenitis Suppurativa | Phase 3 | Recruiting | Novartis Pharmaceuticals | 710 | 2026-07-10 | 2026-10-13 |
| Remibrutinib Open Label Roll-over Post-trial Access Protocol Remibrutinib - Indication of the Parent Protocol | Phase 3 | Recruiting | Novartis Pharmaceuticals | 650 | 2026-04-16 | 2026-10-16 |
| A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis Remibrutinib (blinded), Placebo, Remibrutinib (Open label) - Secondary Progressive Multiple Sclerosis (SPMS) | Phase 3 | Recruiting | Novartis Pharmaceuticals | 1275 | 2025-11-11 | 2026-10-13 |
| A Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Severe Renal Impairment Compared to Matched Healthy Participants. remibrutinib - Autoimmune and Chronic Inflammatory Diseases | Phase 1 | Completed | Novartis Pharmaceuticals | 16 | 2025-07-23 | 2026-09-17 |
| 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 Remibrutinib, Remibrutinib matching placebo, Dupilumab - Chronic Spontaneous Urticaria (CSU) | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 409 | 2025-07-11 | 2026-10-13 |
| Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis. Remibrutinib oral treatment, Ocrelizumab - Relapsing Multiple Sclerosis | Phase 3 | Recruiting | Novartis Pharmaceuticals | 400 | 2025-06-23 | 2026-08-26 |
| Study of Remibrutinib (LOU064) Efficacy and Safety and Exploration of Its Mechanism of Action in Participants With Chronic Urticaria Remibrutinib, Placebo - Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU) | Phase 2 | Recruiting | Novartis Pharmaceuticals | 44 | 2025-05-22 | 2026-09-28 |
| A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa Remibrutinib Dose A, Remibrutinib Dose B, Placebo 1 - Hidradenitis Suppurativa | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 565 | 2025-03-20 | 2026-10-15 |
| A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis Remibrutinib (Blinded), Placebo, Remibrutinib (Open Label) - Generalized Myasthenia Gravis | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 180 | 2025-02-07 | 2026-09-28 |
| A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa (RECHARGE 1) Remibrutinib Dose A, Remibrutinib Dose B, Placebo 1 - Hidradenitis Suppurativa | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 588 | 2025-01-31 | 2026-10-15 |
| A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines Remibrutinib, Placebo - Chronic Inducible Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 362 | 2023-12-07 | 2026-10-15 |
| 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. Remibrutinib, Placebo to remibrutinib, Placebo to omalizumab - Chronic Spontaneous Urticaria | Phase 3 | Active not recruiting | Novartis Pharmaceuticals | 470 | 2023-11-15 | 2026-10-14 |
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Chronic Urticaria (12) · Hidradenitis Suppurativa (5) · Multiple Sclerosis (3) · Recurrence (3) · Charcot-Marie-Tooth disease, Type 1F (2) · Chronic Inducible Urticaria (2) · Cold Urticaria (2) · Dermatitis (2) · Food Hypersensitivity (2) · Hidradenitis (2) · Multiple Sclerosis, Chronic Progressive (2) · Multiple Sclerosis, Relapsing-Remitting (2) · Peanut Hypersensitivity (2) · Urticaria (2) · Arthritis (1)
Novartis Pharmaceuticals (34) · Moein Amin (1) · Washington University School of Medicine (1)
United States (29) · Spain (20) · Germany (19) · Argentina (17) · Canada (17) · France (15) · Poland (15) · United Kingdom (13) · China (12) · Italy (11) · Slovakia (11) · Bulgaria (10) · Czechia (10) · Hungary (10) · Japan (10)
Matthew R Brier, MD, PhD (1) · Moein Amin, MD, MS (1)
PMID 40043237, PMID 42297099, PMID 37866460, PMID 37932009, PMID 41712058, PMID 41854973
2025 (6), 2023 (4), 2018 (2), 2019 (1)