LOU064: Clinical Trials

10 recruiting, 5 active not recruiting, 5 completed, 1 terminated. 14 Phase 3, 5 Phase 2, 2 Phase 1.

By phase and status

Phase	Trials	Status
Phase 3	14	Recruiting 7, Active not recruiting 5, Completed 2
Phase 2	5	Completed 2, Recruiting 2, Terminated 1
Phase 1	2	Completed 1, Recruiting 1

Follow LOU064: new trials by email Literature Review of LOU064 trials Research Report on LOU064

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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 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	2026-10-29	2026-11-10
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	2026-11-09
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	2026-11-09
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	2026-11-09
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	2026-11-09
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	2026-11-10
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	2026-11-09
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
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	2026-10-26
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 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. LOU064 - Chronic Spontaneous Urticaria	Phase 3	Completed	Novartis Pharmaceuticals	144	2023-04-05	2025-10-16
Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts LOU064, placebo - Allergy, Peanut	Phase 2	Completed	Novartis Pharmaceuticals	76	2022-10-12	2026-06-12
A Safety and Efficacy Study of Remibrutinib in the Treatment of CSU in Japanese Adults Inadequately Controlled by H1-antihistamines LOU064 - Chronic Spontaneous Urticaria	Phase 3	Completed	Novartis Pharmaceuticals	71	2022-01-15	2025-04-08
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1) Remibrutinib, Teriflunomide - Relapsing Multiple Sclerosis	Phase 3	Active not recruiting	Novartis Pharmaceuticals	1000	2021-12-16	2026-08-18
Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) Remibrutinib, Teriflunomide - Relapsing Multiple Sclerosis	Phase 3	Active not recruiting	Novartis Pharmaceuticals	1007	2021-12-13	2026-11-12
An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU LOU064 - Chronic Spontaneous Urticaria	Phase 2	Completed	Novartis Pharmaceuticals	229	2019-10-24	2024-06-20
A Phase 2 Study to Evaluate the Safety and Efficacy of LOU064 in Patients With Moderate to Severe Sjögren's Syndrome Remibrutinib, Placebo - Sjögren Syndrome	Phase 2	Terminated	Novartis Pharmaceuticals	73	2019-07-12	2023-01-30

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Conditions studied

Chronic Urticaria (5)  ·  Hidradenitis Suppurativa (4)  ·  Charcot-Marie-Tooth disease, Type 1F (2)  ·  Dermatitis (2)  ·  Food Hypersensitivity (2)  ·  Hidradenitis (2)  ·  Peanut Hypersensitivity (2)  ·  Recurrence (2)  ·  Arthritis (1)  ·  Autoimmune Diseases (1)  ·  Chronic Inducible Urticaria (1)  ·  Cold Urticaria (1)  ·  Connective Tissue Diseases (1)  ·  Dermatitis, Atopic (1)  ·  Dry Eye Syndromes (1)

Sponsors

Novartis Pharmaceuticals (21)

Countries

United States (18)  ·  Canada (13)  ·  Spain (13)  ·  Germany (12)  ·  Argentina (11)  ·  China (9)  ·  France (9)  ·  Poland (9)  ·  Italy (8)  ·  United Kingdom (8)  ·  Slovakia (7)  ·  Australia (6)  ·  Belgium (6)  ·  Bulgaria (6)  ·  Czechia (6)

Results publications

PMID 37866460, PMID 37932009, PMID 41712058, PMID 42915009

NIH funding

2025 (5), 2023 (3), 2018 (1), 2019 (1)