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Showing 1–9 of 9 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LOU064 (blinded) Clear all
Recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504
View directory record Official record
Conditions
Secondary Progressive Multiple Sclerosis (SPMS)
Interventions
Remibrutinib (blinded), Placebo, Remibrutinib (Open label)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
1,275 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2034
U.S. locations
35
States / cities
Birmingham, Alabama • Phoenix, Arizona • Tucson, Arizona + 28 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Active, not recruiting Phase 3 Interventional

An Extension Study of Long-term Efficacy, Safety and Tolerability of Remibrutinib in Chronic Spontaneous Urticaria Patients Who Completed Preceding Studies With Remibrutinib

NCT05513001
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 (blinded), Placebo, LOU064 (open label)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
696 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2027
U.S. locations
43
States / cities
Birmingham, Alabama • Litchfield Park, Arizona • Little Rock, Arkansas + 38 more
Source: ClinicalTrials.gov public record
Updated Mar 10, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Terminated Phase 2 Interventional Results available

Study of Efficacy and Safety of LOU064 in Inadequately Controlled Asthma Patients

NCT03944707
View directory record Official record
Conditions
Asthma
Interventions
LOU064 100 mg, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2020
U.S. locations
4
States / cities
Denver, Colorado • North Dartmouth, Massachusetts • St Louis, Missouri + 1 more
Source: ClinicalTrials.gov public record
Updated Oct 10, 2021 · Synced Sep 21, 2026, 10:09 AM EDT
Recruiting Phase 2 Interventional

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

NCT06865651
View directory record Official record
Conditions
Chronic Urticaria (CU): Chronic Inducible Urticaria (CINDU) and Chronic Spontaneous Urticaria (CSU)
Interventions
Remibrutinib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
44 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
2
States / cities
North Miami Beach, Florida • Glenview, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 8, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Active, not recruiting Phase 3 Interventional

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-up

NCT05677451
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 (blinded), placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 17 Years
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2032
U.S. locations
11
States / cities
Bakersfield, California • San Diego, California • Miami, Florida + 8 more
Source: ClinicalTrials.gov public record
Updated Jul 19, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study of Efficacy and Safety of Remibrutinib in the Treatment of CSU in Adults Inadequately Controlled by H1-antihistamines

NCT05032157
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 (blinded), Placebo, LOU064 (open-label)
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
455 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
30
States / cities
Birmingham, Alabama • Litchfield Park, Arizona • Little Rock, Arkansas + 27 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2025 · Synced Sep 21, 2026, 10:09 AM EDT
Active, not recruiting Phase 2 Interventional Results available

Study of Efficacy and Safety of Investigational Treatments in Patients With Moderate to Severe Hidradenitis Suppurativa

NCT03827798
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
CFZ533, Placebo to CFZ533, LYS006, Placebo to LYS006, MAS825, Placebo to MAS825, LOU064 25mg, LOU064 100mg, Placebo to LOU064, VAY736, Placebo to VAY736
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 65 Years
Enrollment
248 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2026
U.S. locations
8
States / cities
Clearwater, Florida • Orange Park, Florida • Tampa, Florida + 5 more
Source: ClinicalTrials.gov public record
Updated Feb 5, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Completed Phase 2 Interventional Results available

Study of Efficacy, Safety and Tolerability of Remibrutinib in Adult Participants With an Allergy to Peanuts

NCT05432388
View directory record Official record
Conditions
Allergy, Peanut
Interventions
LOU064, placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
76 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
24
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Los Angeles, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jun 11, 2026 · Synced Sep 21, 2026, 10:09 AM EDT
Recruiting Phase 3 Interventional

A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis

NCT06744920
View directory record Official record
Conditions
Generalized Myasthenia Gravis
Interventions
Remibrutinib (Blinded), Placebo, Remibrutinib (Open Label)
Drug · Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 85 Years
Enrollment
180 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2033
U.S. locations
24
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Fullerton, California + 19 more
Source: ClinicalTrials.gov public record
Updated Jul 28, 2026 · Synced Sep 21, 2026, 10:09 AM EDT