Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
NCT ID: NCT05156281
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
800 participants
INTERVENTIONAL
2021-12-13
2030-10-30
Brief Summary
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Detailed Description
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The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).
The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.
A second study of identical design (CLOU064C12301) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Remibrutinib - Core
Remibrutinib tablet and matching placebo of teriflunomide capsule
Remibrutinib
tablet taken orally
Teriflunomide - Core
Teriflunomide capsule and matching placebo remibrutinib tablet
Teriflunomide
capsule taken orally
Remibrutinib - Extension
Participants on remibrutinib in Core will continue on remibrutinib tablet
Remibrutinib
tablet taken orally
Remibrutinib - Extension (on teriflunomide in Core)
Participants on teriflunomide in Core will switch to remibrutinib tablet
Remibrutinib
tablet taken orally
Interventions
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Remibrutinib
tablet taken orally
Teriflunomide
capsule taken orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
* At least: 1 documented relapse within the previous year. OR 2 documented relapses within the previous 2 years, OR 1 active Gadolinium (Gd)-enhancing lesion in the 12 months.
* EDSS score of 0 to 5.5 (inclusive)
* Neurologically stable within 1 month
Exclusion Criteria
* Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
* History of clinically significant CNS disease other than MS
* Ongoing substance abuse (drug or alcohol)
* History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
* Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
* suicidal ideation or behavior
* Evidence of clinically significant cardiovascular, neurological, psychiatric, pulmonary , renal, hepatic, endocrine, metabolic, hematological disorders or gastrointestinal disease that can interfere with interpretation of the study results or protocol adherence
* Participants who have had a splenectomy
* Active clinically significant systemic bacterial, viral, parasitic or fungal infections
* Positive results for syphilis or tuberculosis testing
* Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
* Active, chronic disease of the immune system (including stable disease treated with immune therapy (e.g. Leflunomide, Methotrexate)) other than MS (e.g. rheumatoid arthritis, systemic lupus erythematosus, etc.) with the exception of well-controlled diabetes or thyroid disorder.
* Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
* History or current treatment for hepatic disease including but not limited to acute or chronic hepatitis, cirrhosis (including all Child-Pugh classes) or hepatic failure or any chronic liver or biliary disease.
* History of severe renal disease or creatinine level
* Participants at risk of developing or having reactivation of hepatitis
* Hematology parameters at screening:
* Hemoglobin: \< 10 g/dl (\<100g/L)
* Platelets: \< 100000/mm3 (\<100 x 109/L)
* Absolute lymphocyte count \< 800/mm3 (\<0.8 x 109/L)
* White blood cells: \<3 000/mm3 (\<3.0 x 109/L)
* Neutrophils: \< 1 500/mm3 (\<1.5 x 109/L)
* B-cell count \< 50% lower limit of normal (LLN) or total IgG \& total IgM \< LLN (only required for participants who had a history of receiving B-cell therapies, such as rituximab, ocrelizumab or ofatumumab, prior to screening)
* History or current diagnosis of significant ECG abnormalities
* Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit
* Use of other investigational drugs
* Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
* History of gastrointestinal bleeding
* Major surgery within 8 weeks prior to screening
* History of hypersensitivity to any of the study drugs or excipients
* Pregnant or nursing (lactating) female participants, prior to randomization
* Women of childbearing potential not using highly effective contraception
* Sexually active males not agreeing to use condom
* Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
* Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization
Inclusion to Extension part:
• Participants who complete the Core Part of the study on double-blind study treatment and conduct the Accelerated Elimination Procedure (AEP)
18 Years
55 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Ctr for Neurology and Spine
Phoenix, Arizona, United States
Vladimir Royter MD APMC
Hanford, California, United States
VA Greater LA Healthcare System
Los Angeles, California, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, United States
CU Anschutz Med Campus
Aurora, Colorado, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Colorado Neurological Research PC
Denver, Colorado, United States
New England Institute for Clinical Research
Stamford, Connecticut, United States
Georgetown University Hospital Research
Washington D.C., District of Columbia, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
SFM Clinical Research LLC
Boca Raton, Florida, United States
Nova Clinical Research LLC
Bradenton, Florida, United States
University of Florida
Gainesville, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Neurology Associates PA
Maitland, Florida, United States
Gables Neurology
Miami, Florida, United States
UM Department Of Neurology
Miami, Florida, United States
Aqualane Clinical Research
Naples, Florida, United States
Advent Health Orlando
Orlando, Florida, United States
Humanity Clinical Research
Pembroke Pines, Florida, United States
Emerald Coast Neurology
Pensacola, Florida, United States
Brain and Spine Institute
Port Orange, Florida, United States
Vero Beach Neurology
Vero Beach, Florida, United States
Conquest Research
Winter Park, Florida, United States
Georgia Neurology and Sleep Medicine Assoc
Suwanee, Georgia, United States
Methodist Neuroscience Institute
Merrillville, Indiana, United States
University of Kansas Hospital
Kansas City, Kansas, United States
Baptist Physicians Lexington
Nicholasville, Kentucky, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Clinre Comprehensive Neurology
Frederick, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Memorial Healthcare
Owosso, Michigan, United States
Kansas City VA Medical Center
Kansas City, Missouri, United States
South Shore Neurologic Associates
Patchogue, New York, United States
True North Neurology
Port Jefferson, New York, United States
University Of NC At Chapel Hill
Chapel Hill, North Carolina, United States
Piedmont HealthCare
Charlotte, North Carolina, United States
The Boster Ctr for MS
Columbus, Ohio, United States
Neurology Diagnostics Inc
Dayton, Ohio, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States
Medical Uni of South Carolina
Charleston, South Carolina, United States
Premier Neurology
Greenville, South Carolina, United States
Metrolina Neurological Associates PA
Old Point Station, South Carolina, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, United States
Neurology Consultants Of Dallas PA
Dallas, Texas, United States
Med Research Inc
El Paso, Texas, United States
Lone Star Neurology
Frisco, Texas, United States
Neurocare Plus
Houston, Texas, United States
UT Health MARC Medical Arts and Research Center
San Antonio, Texas, United States
Lonestar Neurology of San Antonio
San Antonio, Texas, United States
Texas Institute for Neurological Disorders
Sherman, Texas, United States
Baylor Scott and White
Temple, Texas, United States
Virginia Mason Medical Centre
Seattle, Washington, United States
University of Washington MS Clinic
Seattle, Washington, United States
Elligo Health Research
Crab Orchard, West Virginia, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Ascension St Francis Center
Milwaukee, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Novartis Investigative Site
Bombal, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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San Miguel de, Tucumán Province, Argentina
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Buenos Aires, , Argentina
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CABA, , Argentina
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Córdoba, , Argentina
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Vitória, Espírito Santo, Brazil
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Brasília, Federal District, Brazil
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Curitiba, Paraná, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Porto Alegre, Rio Grande do Sul, Brazil
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Joinville, Santa Catarina, Brazil
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São Paulo, , Brazil
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Edmonton, Alberta, Canada
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Burnaby, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Ottawa, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Fuzhou, Fujian, China
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Wuhan, Hubei, China
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Wuhan, Hubei, China
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Nanjing, Jiangsu, China
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Yinchuan, Ningxia, China
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Taiyuan, Shanxi, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, , China
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Shanghai, , China
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Shanghai, , China
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Split, HRV, Croatia
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Varaždin, HRV, Croatia
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Vukovar, , Croatia
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Zagreb, , Croatia
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Brno, , Czechia
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Hradec Králové, , Czechia
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Teplice, , Czechia
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Tallinn, , Estonia
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Tartu, , Estonia
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Limoges, Haute Vienne, France
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Toulon, Val De Marne, France
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Caen, , France
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Clermont-Ferrand, , France
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Contamine-sur-Arve, , France
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Dijon, , France
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Gonesse, , France
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Grenoble, , France
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Lille, , France
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Lille, , France
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Marseille, , France
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Nantes, , France
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Nice, , France
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Nîmes, , France
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Poissy, , France
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Suresnes, , France
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Toulouse, , France
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Essen, , Germany
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Hamburg, , Germany
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Siegen, , Germany
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Ulm, , Germany
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Athens, , Greece
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Athens, , Greece
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Chaïdári, , Greece
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Ioannina, , Greece
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Larissa, , Greece
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Thessaloniki, , Greece
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Thessaloniki, , Greece
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Kochi, Kerala, India
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Pune, Maharashtra, India
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Pune, Maharashtra, India
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New Delhi, National Capital Territory of Delhi, India
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Amritsar, Punjab, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Kolkata, West Bengal, India
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Brindisi, BR, Italy
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Foggia, FG, Italy
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Florence, FI, Italy
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Pozzilli, IS, Italy
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Messina, ME, Italy
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Modena, MO, Italy
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Pavia, PV, Italy
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Orbassano, TO, Italy
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Napoli, , Italy
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Nagoya, Aichi-ken, Japan
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Ichihara, Chiba, Japan
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Kōriyama, Fukushima, Japan
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Sapporo, Hokkaido, Japan
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Nishinomiya, Hyōgo, Japan
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Isehara, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Sendai, Miyagi, Japan
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Kashihara, Nara, Japan
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Moriguchi, Osaka, Japan
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Suita, Osaka, Japan
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Higashi-Matsuyama, Saitama, Japan
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Itabashi-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Shinjuku Ku, Tokyo, Japan
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Shinjuku Ku, Tokyo, Japan
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Shinjuku-ku, Tokyo, Japan
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Chiba, , Japan
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Fukuoka, , Japan
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Fukuoka, , Japan
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Kobe, , Japan
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Kyoto, , Japan
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Niigata, , Japan
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Mexico City, Mexico City, Mexico
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Chihuahua City, , Mexico
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Mexico City, , Mexico
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Querétaro, , Mexico
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Plewiska, Poznan, Poland
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Bialystok, , Poland
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Glogow Wielkopolski, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Braga, , Portugal
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Coimbra, , Portugal
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Leiria, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Matosinhos Municipality, , Portugal
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Santa Maria da Feira, , Portugal
Caribbean Center for Clinical Research, Inc
Guaynabo, , Puerto Rico
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Târgu Mureş, Mureș County, Romania
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Brasov, ROM, Romania
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Constanța, ROM, Romania
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Bucharest, , Romania
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Campulung Muscel, , Romania
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Constanța, , Romania
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Suceava, , Romania
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Banská Bystrica, , Slovakia
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Banská Bystrica, , Slovakia
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Bratislava, , Slovakia
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Celje, , Slovenia
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Ljubljana, , Slovenia
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Maribor, , Slovenia
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Bloemfontein, Free State, South Africa
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Pretoria, , South Africa
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Rosebank, , South Africa
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Santiago Compostela, A Coruna, Spain
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Vitoria-Gasteiz, Araba, Spain
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Badalona, Barcelona, Spain
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L'Hospitalet de Llobregat, Barcelona, Spain
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Albacete, Castille-La Mancha, Spain
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Barcelona, Catalonia, Spain
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Logroño, La Rioja, Spain
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Pozuelo de Alarcón, Madrid, Spain
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Torrejón de Ardoz, Madrid, Spain
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Gijón, Principality of Asturias, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Lleida, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Seville, , Spain
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Valencia, , Spain
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Stockholm, , Sweden
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Stockholm, , Sweden
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Samsun, Atakum, Turkey (Türkiye)
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Izmir, Balcova, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Izmir, Karabaglar, Turkey (Türkiye)
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Kayseri, Melikgazi, Turkey (Türkiye)
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Bursa, Nilufer, Turkey (Türkiye)
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Istanbul, Pendik, Turkey (Türkiye)
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Istanbul, Sancaktepe, Turkey (Türkiye)
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Kocaeli, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Inverness, Invernesshire, United Kingdom
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Canterbury, Kent, United Kingdom
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London, , United Kingdom
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Facility Contacts
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Other Identifiers
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2023-509372-41-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLOU064C12302
Identifier Type: -
Identifier Source: org_study_id