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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

Conditions: Chronic Pruritus of Unknown Origin
Interventions: Remibrutinib, Placebo; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 180 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 8
States / cities: Miami, Florida • Savannah, Georgia • Indianapolis, Indiana + 5 more

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

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

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: 18
States / cities: Birmingham, Alabama • Scottsdale, Arizona • Little Rock, Arkansas + 15 more

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: 23
States / cities: Phoenix, Arizona • Scottsdale, Arizona • Fullerton, California + 18 more

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

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

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

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

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

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

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

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

Conditions: Hidradenitis Suppurativa
Interventions: LOU064, Placebo; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years to 65 Years
Enrollment: 30 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2028
U.S. locations: 1
States / cities: Mayfield Heights, Ohio

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

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

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: 21
States / cities: Birmingham, Alabama • Fort Smith, Arkansas • North Little Rock, Arkansas + 17 more

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

Conditions: Chronic Pruritus of Unknown Origin
Interventions: Remibrutinib, Placebo; Drug
Lead sponsor: Novartis Pharmaceuticals; Industry
Eligibility: 18 Years and older
Enrollment: 180 participants
Healthy volunteers: Healthy volunteers not accepted
Timeline: 2026 – 2030
U.S. locations: 7
States / cities: Tampa, Florida • Brighton, Massachusetts • Clarkston, Michigan + 4 more

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

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

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

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

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

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

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)

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

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

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

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

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

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

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

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

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

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

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

A Study to Explore the Tissue Level Effects of Remibrutinib in Adults With Moderate to Severe HS

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

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

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

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

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

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.

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

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

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