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Showing 1–24 of 24 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: LOU064 Clear all
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 2, 2026, 1:33 AM EDT
Recruiting Phase 3 Interventional

An Extension Study to Assess Safety and Efficacy of Remibrutinib in Participants With Moderate to Severe HS

NCT07665437
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
Remibrutinib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
710 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2031
U.S. locations
5
States / cities
Fort Smith, Arkansas • Fremont, California • Thousand Oaks, California + 2 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 2, 2026, 1:33 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

NCT05030311
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 25 mg (b.i.d), Placebo, LOU064 25 mg (b.i.d) as a tablet.
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
470 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2024
U.S. locations
26
States / cities
Birmingham, Alabama • North Little Rock, Arkansas • Bakersfield, California + 23 more
Source: ClinicalTrials.gov public record
Updated Apr 7, 2025 · Synced Sep 2, 2026, 1:33 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 2, 2026, 1:33 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 2, 2026, 1:33 AM EDT
Active, not recruiting Phase 3 Interventional

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)

NCT06799000
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
Remibrutinib Dose A, Remibrutinib Dose B, Placebo 1, Placebo 2
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 100 Years
Enrollment
588 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
36
States / cities
Phoenix, Arizona • Fort Smith, Arkansas • North Little Rock, Arkansas + 32 more
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Active, not recruiting Phase 3 Interventional

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

NCT05147220
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Remibrutinib, Teriflunomide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
1,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
52
States / cities
Phoenix, Arizona • Tucson, Arizona • Fort Smith, Arkansas + 47 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Recruiting Phase 3 Interventional

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

NCT07768371
View directory record Official record
Conditions
IgE-Mediated Food Allergy, Peanut Allergy, Cow Milk Allergy, Egg Allergy
Interventions
Remibrutinib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 65 Years
Enrollment
576 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
3
States / cities
Los Angeles, California • North Charleston, South Carolina • El Paso, Texas
Source: ClinicalTrials.gov public record
Updated Aug 27, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Active, not recruiting Phase 3 Interventional

A Phase 3 Study to Assess Efficacy Safety and Tolerability of Remibrutinib in Adult and Adolescent Patients With Moderate to Severe Hidradenitis Suppurativa

NCT06840392
View directory record Official record
Conditions
Hidradenitis Suppurativa
Interventions
Remibrutinib Dose A, Remibrutinib Dose B, Placebo 1, Placebo 2
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
12 Years to 100 Years
Enrollment
565 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
35
States / cities
Birmingham, Alabama • Gilbert, Arizona • Fremont, California + 30 more
Source: ClinicalTrials.gov public record
Updated Aug 20, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Completed Phase 2 Interventional Results available

An Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of LOU064 in Subjects With CSU

NCT04109313
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
229 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2022
U.S. locations
10
States / cities
Litchfield Park, Arizona • Little Rock, Arkansas • Mission Viejo, California + 7 more
Source: ClinicalTrials.gov public record
Updated Jun 19, 2024 · Synced Sep 2, 2026, 1:33 AM EDT
Terminated Phase 2 Interventional Results available

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

NCT04035668
View directory record Official record
Conditions
Sjögren Syndrome
Interventions
Remibrutinib, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
73 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
1
States / cities
Boston, Massachusetts
Source: ClinicalTrials.gov public record
Updated Jan 29, 2023 · Synced Sep 2, 2026, 1:33 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 2, 2026, 1:33 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 2, 2026, 1:33 AM EDT
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 2, 2026, 1:33 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 2, 2026, 1:33 AM EDT
Active, not recruiting Phase 3 Interventional

A Study to Investigate Efficacy, Safety, and Tolerability of Remibrutinib Compared With Placebo in Adults With CINDU Inadequately Controlled by H1-antihistamines

NCT05976243
View directory record Official record
Conditions
Chronic Inducible Urticaria
Interventions
Remibrutinib, Placebo
Drug · Other
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 100 Years
Enrollment
362 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2029
U.S. locations
25
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Bakersfield, California + 21 more
Source: ClinicalTrials.gov public record
Updated Aug 19, 2026 · Synced Sep 2, 2026, 1:33 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 2, 2026, 1:33 AM EDT
Recruiting Phase 2 Interventional

A Phase 2 Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib (LOU064) in Adult Patients With Papulopustular Rosacea (PPR)

NCT07681271
View directory record Official record
Conditions
Papulopustular Rosacea
Interventions
LOU064, Placebo
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
100 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2027
U.S. locations
1
States / cities
El Paso, Texas
Source: ClinicalTrials.gov public record
Updated Aug 11, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

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

NCT07032272
View directory record Official record
Conditions
Autoimmune and Chronic Inflammatory Diseases
Interventions
remibrutinib
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025
U.S. locations
4
States / cities
Miami, Florida • Miami Lakes, Florida • Orlando, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Mar 29, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Completed Phase 3 Interventional Results available

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.

NCT05795153
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
144 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2023 – 2024
U.S. locations
10
States / cities
Little Rock, Arkansas • Aventura, Florida • Greenacres City, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Oct 15, 2025 · Synced Sep 2, 2026, 1:33 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 Aug 18, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Completed Phase 2 Interventional Results available

This Was a Dose-finding Study to Evaluate Efficacy and Safety of LOU064 in Patients With CSU Inadequately Controlled by H1-antihistamines

NCT03926611
View directory record Official record
Conditions
Chronic Spontaneous Urticaria
Interventions
LOU064 Arm 1, LOU064 Arm 2, LOU064 Arm 3, LOU064 Arm 4, LOU064 Arm 5, LOU064 Arm 6, Placebo arm
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 99 Years
Enrollment
311 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2019 – 2021
U.S. locations
11
States / cities
Litchfield Park, Arizona • Little Rock, Arkansas • Mission Viejo, California + 8 more
Source: ClinicalTrials.gov public record
Updated Apr 28, 2022 · Synced Sep 2, 2026, 1:33 AM EDT
Active, not recruiting Phase 3 Interventional

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

NCT05156281
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Remibrutinib, Teriflunomide
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
18 Years to 55 Years
Enrollment
1,007 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2021 – 2030
U.S. locations
50
States / cities
Phoenix, Arizona • Hanford, California • Los Angeles, California + 42 more
Source: ClinicalTrials.gov public record
Updated Aug 17, 2026 · Synced Sep 2, 2026, 1:33 AM EDT
Recruiting Phase 3 Interventional

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

NCT06846281
View directory record Official record
Conditions
Relapsing Multiple Sclerosis
Interventions
Remibrutinib oral treatment, Ocrelizumab
Drug
Lead sponsor
Novartis Pharmaceuticals
Industry
Eligibility
40 Years to 70 Years
Enrollment
400 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2031
U.S. locations
44
States / cities
Scottsdale, Arizona • Irvine, California • Washington D.C., District of Columbia + 39 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 2, 2026, 1:33 AM EDT