Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
NCT ID: NCT05147220
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
2021-12-16
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 (CLOU064C12302) 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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AZ Integrated Neuro and Spine
Phoenix, Arizona, United States
Honor Health Research Institute
Scottsdale, Arizona, United States
Center for Neurosciences
Tucson, Arizona, United States
The Belinga Clinic
Fort Smith, Arkansas, United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, United States
The Neuron Clinic
Chula Vista, California, United States
Neur Ctr of N Orange County
Fullerton, California, United States
Glendale Adventist Medical Center
Glendale, California, United States
Hoag Health System
Newport Beach, California, United States
SC3 Research Pasadena
Pasadena, California, United States
Neuro Center
Pomona, California, United States
Mountain Neuro Research Center PC
Basalt, Colorado, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
Christiana Care Health Services
Newark, Delaware, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
Homestead Assoc In Research Inc
Homestead, Florida, United States
Reliant Medical Research
Miami, Florida, United States
US Associates in Research
Miami, Florida, United States
Neurological Services of Orlando PA
Orlando, Florida, United States
Orlando Health Clinical Trials
Orlando, Florida, United States
Comprehensive Neurology Clinic
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Neurostudies Inc
Port Charlotte, Florida, United States
Accel Research Sites St Pete-Largo
Seminole, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
University Of South Florida
Tampa, Florida, United States
Conquest Research
Winter Park, Florida, United States
Velocity Clinical Research
Savannah, Georgia, United States
Hawaii Pacific Neuroscience LLC
Honolulu, Hawaii, United States
Rush University Medical Center
Chicago, Illinois, United States
Insight Hospital and Medical Center
Chicago, Illinois, United States
Advocate Medical Group
Park Ridge, Illinois, United States
Springfield Clinic
Springfield, Illinois, United States
IU Health Inc
Fort Wayne, Indiana, United States
College Park Family Care Center
Overland Park, Kansas, United States
Norton Neurology MS Services
Louisville, Kentucky, United States
American Oncology Partners PA Center for Cancer & Blood Disorders
Bethesda, Maryland, United States
International Neurorehab Institute
Lutherville, Maryland, United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, United States
Lahey Clinic
Burlington, Massachusetts, United States
Neurology Center of New England PC
Foxborough, Massachusetts, United States
Wayne State University Multiple Sclerosis Clinic
Detroit, Michigan, United States
The MS Center for Innovation in Care
St Louis, Missouri, United States
SCL Health
Billings, Montana, United States
Jersey Shore University Medical Ctr
Neptune City, New Jersey, United States
NYU Langone Health
Brooklyn, New York, United States
Neurological Associates of Long Island PC
Lake Success, New York, United States
NYU Langone Med Center CV Research
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
The Neurological Institute PA
Charlotte, North Carolina, United States
Velocity Clinical Research
Raleigh, North Carolina, United States
Columbus Neuroscience
Westerville, Ohio, United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, United States
Providence St Vincent Med Center
Portland, Oregon, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University Of Pittsburgh Medical Ctr Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States
Reading Hospital
Reading, Pennsylvania, United States
Palmetto Clinical Research
Summerville, South Carolina, United States
Texas Neurology
Dallas, Texas, United States
Univ of Texas Southwest Med Center
Dallas, Texas, United States
Advc Neurology Epilepsy and Sleep
El Paso, Texas, United States
John Peter Smith Hospital
Fort Worth, Texas, United States
Neuro Eye Clinical Trials Inc
Houston, Texas, United States
DHR Health Institute
McAllen, Texas, United States
Saturn Research Solutions LLC
Plano, Texas, United States
The University of Utah
Salt Lake City, Utah, United States
MS Center of Greater Washington, P.C.
Vienna, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Wisconsin Madison
Madison, Wisconsin, United States
Neuroscience Group
Neenah, Wisconsin, United States
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Capital Federal, Buenos Aires, Argentina
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Rosario, Santa Fe Province, Argentina
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Caba, , Argentina
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Capital Federal, , Argentina
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Linz, Upper Austria, Austria
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Graz, , Austria
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Melsbroek, , Belgium
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Overpelt, , Belgium
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Porto Alegre, Porto Alegre RS, Brazil
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Santo André, São Paulo, Brazil
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Pleven, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Santiago, Santiago Metropolitan, Chile
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Beijing, Beijing Municipality, China
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Zhengzhou, Henan, China
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Changsha, Hunan, China
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Baotou, Inner Mongolia, China
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Hohhot, Inner Mongolia, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Beijing, , China
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Chongqing, , China
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Tianjin, , China
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Puerto Colombia, Atlántico, Colombia
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Cali, Valle del Cauca Department, Colombia
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Cali, Valle del Cauca Department, Colombia
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Bogotá, , Colombia
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Medellín, , Colombia
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Osijek, , Croatia
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Rijeka, , Croatia
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Zadar, , Croatia
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Zagreb, , Croatia
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Slagelse, , Denmark
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Tbilisi, , Georgia
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Guatemala City, , Guatemala
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Shatin, , Hong Kong
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Mangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Nashik, Maharashtra, India
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Chandigarh, Punjab, India
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Hyderabad, Telangana, India
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Lucknow, Uttar Pradesh, India
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Dehradun, Uttarakhand, India
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Dublin, , Ireland
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Ashkelon, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Sefad, , Israel
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Tel Aviv, , Israel
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Montichiari, BS, Italy
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Milan, MI, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Verona, VR, Italy
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Napoli, , Italy
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Novara, , Italy
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Amman, , Jordan
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Riga, LV, Latvia
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Riga, , Latvia
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Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Tripoli, , Lebanon
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Šiauliai, LTU, Lithuania
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Klaipėda, , Lithuania
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Kuala Lumpur, Kuala Lumpur, Malaysia
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Seberang Jaya, Pulau Pinang, Malaysia
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Kuching, Sarawak, Malaysia
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Kuala Terengganu, Terengganu, Malaysia
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Zapopan, Jalisco, Mexico
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San Pedro G G, , Mexico
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Veracruz, , Mexico
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's-Hertogenbosch, North Brabant, Netherlands
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Dordrecht, South Holland, Netherlands
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Rotterdam, South Holland, Netherlands
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bydgoszcz, Woj Kujawsko Pomorskie, Poland
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Kielce, , Poland
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Lodz, , Poland
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Piotrkow Trybunalski, , Poland
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Poznan, , Poland
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Rzeszów, , Poland
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Szczecin, , Poland
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Jeddah, , Saudi Arabia
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Jeddah, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Bratislava, , Slovakia
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Košice, , Slovakia
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Nitra, , Slovakia
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Trnava, , Slovakia
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Cadiz, Andalusia, Spain
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Seville, Andalusia, Spain
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Sant Joan Despí, Barcelona, Spain
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Salt, Girona, Spain
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Alcorcón, Madrid, Spain
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Getafe, Madrid, Spain
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Majadahonda, Madrid, Spain
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El Palmar, Murcia, Spain
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Vigo, Pontevedra, Spain
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Castilleja de la Cuesta, Sevilla, Spain
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Barakaldo, Vizcaya, Spain
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A Coruña, , Spain
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Barcelona, , Spain
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Córdoba, , Spain
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Las Palmas GC, , Spain
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León, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Málaga, , Spain
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Valencia, , Spain
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Valladolid, , Spain
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Basel, , Switzerland
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Bern, , Switzerland
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Ankara, Bilkent-Cankaya, Turkey (Türkiye)
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Izmir, Karsiyaka, Turkey (Türkiye)
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Istanbul, Sultangazi, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Mersin, Yenisehir, Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Abu Dhabi, , United Arab Emirates
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Dubai, , United Arab Emirates
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Westbruy on Trym, Bristol, United Kingdom
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Winchester, Hampshire, United Kingdom
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Glasgow, Scotland, 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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CLOU064C12301
Identifier Type: -
Identifier Source: org_study_id
2020-005899-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id