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

NCT07225504 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: CLOU064P123012025-521546-23
• Study Type: interventional
• Target: 1,275
• Locations: 25 countries
• Sites: 162

Brief Summary

The purpose of this study is to provide efficacy and safety data for remibrutinib in patients with secondary progressive multiple sclerosis (SPMS)

Conditions

Secondary Progressive Multiple Sclerosis (SPMS)

Keywords

MS; Multiple sclerosis; secondary progressive multiple sclerosis; SPMS; remibrutinib; LOU064; adult; Expanded Disability Status Scale; EDSS; McDonald diagnostic criteria

Outcome Measures

Primary Outcomes (1)

• Time to 6-month confirmed disability progression (6mCDP) on Expanded Disability Status Scale (EDSS)

  The EDSS is an ordinal scale used for assessing neurologic impairment in MS based on a neurological examination. It consists of scores in each of seven functional systems and an ambulation score that are then combined to determine the EDSS steps (ranging from 0 (normal) to 10 (death due to MS)). 6mCDP is defined as an increase from baseline in EDSS sustained for at least 6 months.

  From baseline up to approximately 5 years

Secondary Outcomes (8)

• Time to 3-month confirmed disability progression (3mCDP) on EDSS

  From baseline up to approximately 5 years

• Time to 6-month confirmed disability improvement (6mCDI) on EDSS

  From baseline up to approximately 5 years

• Time to 3-month worsening by at least 20% in Timed 25-Foot Walk (T25FW)

  From baseline up to approximately 5 years

• Time to 3-month worsening by at least 20% in 9-Hole Peg Test (9-HPT)

  From baseline up to approximately 5 years

• Annualized rate of new or enlarging T2 lesions

  From baseline up to approximately 5 years

Study Arms (2)

Remibrutinib (LOU064)

EXPERIMENTAL

Core Part: Remibrutinib film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

Drug: Remibrutinib (blinded); Drug: Remibrutinib (Open label)

Placebo

PLACEBO COMPARATOR

Core Part: Matching placebo film-coated tablet taken orally \[Extension Part: Open-label remibrutinib film-coated tablet taken orally\]

Drug: Placebo; Drug: Remibrutinib (Open label)

Interventions

Remibrutinib (blinded) DRUG

Remibrutinib (Blinded) active treatment, oral tablet

Also known as: LOU064

Remibrutinib (LOU064)

Placebo DRUG

Matching placebo (binded), oral tablet

Placebo

Remibrutinib (Open label) DRUG

Remibrutinib (Open Label), oral tablet

Also known as: LOU064

Placebo; Remibrutinib (LOU064)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent must be obtained prior to any assessment performed.
• Male or female participants aged 18-65 (inclusive) at Screening.
• Diagnosis of SPMS according to the 2017 revised McDonald criteria (Thompson et al 2018) at Screening.
• Absence of documented clinical relapses in the 24 months before Screening and randomization.
• EDSS score of 3.0 to 6.0 (inclusive) at Screening.
• Documented evidence of disability progression in the 12 months before Screening.

You may not qualify if:

• Unwilling or unable to undergo MRI scans as per protocol (for example, claustrophobia, or presents absolute contraindications to MRI (e.g., metallic implants, metallic foreign bodies, pacemaker, defibrillator)).
• History of clinically significant central nervous system (CNS) disease (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic multiple sclerosis (MS).
• Ongoing substance abuse (drug or alcohol) or any other factor (e.g. serious psychiatric condition) that may interfere with the participant's ability to cooperate and comply with the study procedures.
• Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML.
• Women of childbearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant from menarche until becoming post-menopausal, unless they are using highly effective methods of contraception (failure rate \< 1% per year) while taking study treatment and for at least 1 week after stopping study treatment.
• Significant bleeding risk or coagulation disorders, at Screening.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (164)

Alabama Neurology Associates PC

Birmingham, Alabama, 35209, United States

RECRUITING

AZ Integrated Neuro and Spine

Phoenix, Arizona, 85037, United States

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Center for Neurosciences

Tucson, Arizona, 85718, United States

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Fullerton Neuro and Headache Ctr

Fullerton, California, 92835, United States

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Regina Berkovich MD PhD Inc

West Hollywood, California, 90048, United States

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Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

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Medstar Washington Hosp Ctr

Washington D.C., District of Columbia, 20010, United States

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Neurology of Central FL Res Ctr

Altamonte Springs, Florida, 32714, United States

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UF Health Cancer Center

Gainesville, Florida, 32610, United States

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Neurology Associates PA

Maitland, Florida, 32751, United States

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Miami NS Ins Baptist Health S FL

Miami, Florida, 33176, United States

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Aqualane Clinical Research

Naples, Florida, 34105, United States

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Orlando Health Clinical Trials

Orlando, Florida, 32806, United States

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Comprehensive Neurology Clinic

Orlando, Florida, 32825, United States

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Neurology Associates of Ormond Beach

Ormond Beach, Florida, 32174, United States

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Axiom Brain Health

Tampa, Florida, 33609, United States

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Joi Life Wellness Group LLC

Smyrna, Georgia, 30080, United States

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Hawaii Pacific Neuroscience LLC

Honolulu, Hawaii, 96817, United States

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University of Kansas Hospital

Kansas City, Kansas, 66160, United States

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Mid Atlantic Epilepsy and Sleep Ctr

Bethesda, Maryland, 20817-1807, United States

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Michigan Institute of Neurological

Farmington Hills, Michigan, 48334, United States

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University of New Mexico Hospital

Albuquerque, New Mexico, 87106, United States

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Neurology Clinic PC

Cordova, Tennessee, 38018, United States

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Saturn Research Solution

Plano, Texas, 75024, United States

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Citta Clinical Research

Spokane, Washington, 99202, United States

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Novartis Investigative Site

Capital Federal, Buenos Aires, 1424, Argentina

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Novartis Investigative Site

Bombal, Mendoza Province, M5500DXO, Argentina

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Novartis Investigative Site

Buenos Aires, C1012AAR, Argentina

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Novartis Investigative Site

Caba, C1055AAF, Argentina

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CABA, C1181ACH, Argentina

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Caba, C1424BYD, Argentina

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Santiago del Estero, 4200, Argentina

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Kogarah, New South Wales, 2217, Australia

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New Lambton Heights, New South Wales, 2305, Australia

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Westmead, New South Wales, 2145, Australia

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Clayton, Victoria, 3168, Australia

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Heidelberg, Victoria, 3084, Australia

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Linz, 4020, Austria

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Vienna, 1180, Austria

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Pleven, 5800, Bulgaria

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Novartis Investigative Site

Sofia, 1113, Bulgaria

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Novartis Investigative Site

Sofia, 1407, Bulgaria

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Novartis Investigative Site

Sofia, 1431, Bulgaria

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Novartis Investigative Site

Sofia, 1510, Bulgaria

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Novartis Investigative Site

Sofia, 1606, Bulgaria

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Vancouver, British Columbia, V6T 2A1, Canada

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Ottawa, Ontario, K1H 8L6, Canada

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Lévis, Quebec, G6W 0M5, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Montreal, Quebec, H3A 2B4, Canada

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Montreal, Quebec, H4A 3T2, Canada

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Sherbrooke, Quebec, J1H 5N4, Canada

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Guangzhou, Guangdong, 510030, China

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Zhengzhou, Henan, 450003, China

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Wuhan, Hubei, 430030, China

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Hohhot, Inner Mongolia, 010017, China

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Suzhou, Jiangsu, 215004, China

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Changchun, Jilin, 130021, China

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Xianyang, Shaanxi, 712000, China

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Taiyuan, Shanxi, 030001, China

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Hangzhou, Zhejiang, 310016, China

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Wenzhou, Zhejiang, 325000, China

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Beijing, 065001, China

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Beijing, 100034, China

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Chongqing, 400016, China

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Shanghai, 200040, China

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Tianjin, 300052, China

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Barranquilla, Atlántico, 080020, Colombia

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Bogotá, 111321, Colombia

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Medellín, 050001, Colombia

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Medellín, 050034, Colombia

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Jihlava, 586 01, Czechia

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Prague, 140 59, Czechia

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Prague, 150 06, Czechia

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Teplice, 415 29, Czechia

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Esbjerg, 6700, Denmark

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Limoges, Haute Vienne, 87000, France

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Ajaccio, 20090, France

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Amiens, 80054, France

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Clermont-Ferrand, 63003, France

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Gonesse, 95500, France

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Grenoble, 38043, France

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Lille, 59000, France

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Lille, 59037, France

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Montpellier, 34090, France

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Novartis Investigative Site

Nancy, 54035, France

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Nice, 06000, France

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Nîmes, 30029, France

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Orsay, 91400, France

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Paris, 75013, France

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Novartis Investigative Site

Paris, 75940, France

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Poitiers, 86021, France

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Rennes, 35033, France

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Rouen, 76031, France

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Toulouse, 31059, France

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Tours, 37044, France

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Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

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Mannheim, Baden-Wurttemberg, 68167, Germany

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Munich, Bavaria, 81377, Germany

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Unterhaching, Bavaria, 82008, Germany

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Halle, Saxony-Anhalt, 06120, Germany

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Erfurt, 99089, Germany

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Giessen, 35392, Germany

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Greifswald, 17475, Germany

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Heidelberg, 69120, Germany

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Itzehoe, 25524, Germany

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Chaïdári, 124 62, Greece

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Budapest, 1044, Hungary

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Kistarcsa, 2143, Hungary

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Gurugram, Haryana, 122011, India

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Mangalore, Karnataka, 575003, India

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Kochi, Kerala, 682025, India

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New Delhi, National Capital Territory of Delhi, 110029, India

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New Delhi, National Capital Territory of Delhi, 110060, India

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Chandigarh, Punjab, 160012, India

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Vellore, Tamil Nadu, 632 004, India

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Hyderabad, Telangana, 500082, India

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Jerusalem, 9112001, Israel

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Ramat Gan, 5265601, Israel

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Rehovot, 7661041, Israel

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Tel Aviv, 6423906, Israel

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Ẕerifin, 7030000, Israel

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Bergamo, BG, 24127, Italy

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Foggia, FG, 71122, Italy

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Pozzilli, IS, 86077, Italy

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Pavia, PV, 27100, Italy

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Roma, RM, 00133, Italy

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Arnhem, Gelderland, 6815 AD, Netherlands

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Leiden, 2334 CN, Netherlands

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Bydgoszcz, Woj Kujawsko Pomorskie, 85-796, Poland

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Chojnice, 89-600, Poland

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Katowice, 40-081, Poland

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Katowice, 40-686, Poland

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Rzeszów, 35-323, Poland

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Zabrze, 41-800, Poland

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Braga, 4710243, Portugal

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Lisbon, 1349-019, Portugal

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Porto, 4200 319, Portugal

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Constanța, ROM, 900123, Romania

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Bucharest, 040215, Romania

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Campulung Muscel, 115100, Romania

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Bratislava, 851 01, Slovakia

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Komárno, 945 05, Slovakia

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Trnava, 917 02, Slovakia

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Cape Town, Western Cape, 7405, South Africa

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L'Hospitalet de Llobregat, Barcelona, 08907, Spain

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Torrejón de Ardoz, Madrid, 28850, Spain

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El Palmar, Murcia, 30120, Spain

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Castilleja de la Cuesta, Sevilla, 41950, Spain

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Valencia, Valencia, 46017, Spain

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Barcelona, 08035, Spain

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Las Palmas GC, 35010, Spain

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Lleida, 25198, Spain

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Novartis Investigative Site

Madrid, 28009, Spain

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Madrid, 28034, Spain

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Novartis Investigative Site

Madrid, 28040, Spain

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Málaga, 29010, Spain

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Salamanca, 37007, Spain

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Valencia, 46026, Spain

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Bern, 3010, Switzerland

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Lausanne, 1011, Switzerland

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Brighton, East Sussex, BN2 5BE, United Kingdom

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Coventry, CV2 2DX, United Kingdom

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Novartis Investigative Site

Glasgow, G51 4TF, United Kingdom

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MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive; Multiple Sclerosis

Interventions

remibrutinib

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blind on Core part and Open label on Extension part
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: November 4, 2025
• First Posted: November 6, 2025
• Study Start: November 11, 2025
• Primary Completion (Estimated): December 3, 2030
• Study Completion (Estimated): January 2, 2034
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (25); AU (5); IL (5); CA (7); DK (1); GR (1); CH (2); PT (3); GB (3); FR (20); ES (14); CN (15); BU (6); IT (5); PL (6); SL (3); CO (4); HU (2); RO (3); CZ (4); AR (7); DE (10); IN (8); NL (2); ZA (1)