Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Launched by NOVARTIS PHARMACEUTICALS · Dec 1, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the effectiveness and safety of a new treatment called remibrutinib compared to an existing drug, teriflunomide, in people with relapsing multiple sclerosis (RMS). RMS is a type of multiple sclerosis characterized by episodes of symptoms that come and go. The trial is currently looking for participants aged between 18 and 55 who have had at least one relapse in the past year or two relapses in the last two years. Potential participants should also have a specific level of disability, as measured by the Expanded Disability Status Scale (EDSS), and must be stable in their condition for at least a month before joining the study.
If you decide to participate, you can expect to be part of a study that aims to better understand how well remibrutinib works compared to teriflunomide. You will receive either of the treatments for a period of time, and your health will be closely monitored. It's important to note that there are certain health conditions and factors that may exclude you from participating, such as having primary progressive multiple sclerosis or significant other health issues. Overall, this trial aims to identify a potentially effective treatment option for those living with RMS.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 18 to 55 years of age
- • 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:
- • Diagnosis of primary progressive multiple sclerosis (PPMS)
- • 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)
- • Other inclusion and exclusion criteria may apply.
About Novartis Pharmaceuticals
Novartis Pharmaceuticals is a global healthcare company dedicated to reimagining medicine to improve and extend people's lives. With a strong focus on innovation, Novartis engages in the research, development, and commercialization of a broad range of therapies across various therapeutic areas, including oncology, cardiology, dermatology, and neuroscience. The company is committed to advancing scientific knowledge and patient care through clinical trials that prioritize safety and efficacy. Novartis leverages cutting-edge technology and collaborative partnerships to address unmet medical needs and deliver transformative treatments that enhance patient outcomes worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Milwaukee, Wisconsin, United States
Gainesville, Florida, United States
New Orleans, Louisiana, United States
Jacksonville, Florida, United States
Owosso, Michigan, United States
Boston, Massachusetts, United States
San Antonio, Texas, United States
Maitland, Florida, United States
Hershey, Pennsylvania, United States
Aurora, Colorado, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
New Orleans, Louisiana, United States
Kansas City, Kansas, United States
Dijon, , France
Pavia, Pv, Italy
Orbassano, To, Italy
Napoli, , Italy
Hospitalet De Llobregat, Catalunya, Spain
Kansas City, Missouri, United States
Boston, Massachusetts, United States
San Antonio, Texas, United States
Edmonton, Alberta, Canada
Hospitalet De Llobregat, Barcelona, Spain
Miami, Florida, United States
Green Bay, Wisconsin, United States
Ottawa, Ontario, Canada
Modena, Mo, Italy
Kansas City, Kansas, United States
Wuhan, Hubei, China
Stockholm, , Sweden
Green Bay, Wisconsin, United States
Athens, , Greece
Banska Bystrica, , Slovakia
Ljubljana, , Slovenia
Maribor, , Slovenia
Shanghai, , China
Maitland, Florida, United States
Dayton, Ohio, United States
Toulouse Cedex 9, , France
Grenoble, , France
Lille Cedex, , France
Denver, Colorado, United States
Milwaukee, Wisconsin, United States
Winter Park, Florida, United States
Quebec, , Canada
Nice Cedex, , France
Firenze, Fi, Italy
Nagoya, Aichi, Japan
Nishinomiya, Hyogo, Japan
Shinjuku Ku, Tokyo, Japan
Chiba, , Japan
Niigata, , Japan
Valencia, Comunidad Valenciana, Spain
Santiago De Compostela, Galicia, Spain
Istanbul, Tur, Turkey
Izmir, , Turkey
Colorado Springs, Colorado, United States
Orlando, Florida, United States
Seattle, Washington, United States
Zagreb, , Croatia
Tartu, , Estonia
Lille, , France
Pretoria, , South Africa
Canterbury, Kent, United Kingdom
Hangzhou, Zhejiang, China
Kyoto, , Japan
Caba, Buenos Aires, Argentina
Fuzhou, Fujian, China
Nanjing, Jiangsu, China
Hangzhou, Zhejiang, China
Beijing, , China
Foggia, Fg, Italy
Pozzilli, Is, Italy
Sevilla, Andalucia, Spain
Valencia, Comunidad Valenciana, Spain
Kocaeli, , Turkey
Pembroke Pines, Florida, United States
Istanbul, , Turkey
Rosario, Santa Fe, Argentina
Greenfield Park, Quebec, Canada
Napoli, , Italy
Valencia, , Spain
Port Orange, Florida, United States
Porto Alegre, Rio Grande Do Sul, Brazil
Barcelona, Catalunya, Spain
Suresnes, , France
Burnaby, British Columbia, Canada
Halifax, Nova Scotia, Canada
Nantes Cedex 1, , France
Badalona, Catalunya, Spain
Kobe Shi, Hyogo, Japan
Seattle, Washington, United States
Hollywood, Florida, United States
Ioannina, Gr, Greece
Brindisi, Br, Italy
Pozuelo De Alarcon, Madrid, Spain
Pensacola, Florida, United States
Los Angeles, California, United States
Charlotte, North Carolina, United States
Pune, Maharashtra, India
Hyderabad, Telangana, India
Zabrze, , Poland
Targu Mures, Mures, Romania
Madrid, , Spain
Caen Cedex, , France
Nimes, , France
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Nice, , France
Itabashi Ku, Tokyo, Japan
Fukuoka City, Fukuoka, Japan
Larissa, Gr, Greece
Sofia, , Bulgaria
Bloemfontein, Free State, South Africa
Clermont Ferrand Cedex 1, , France
Bucharest, District 2, Romania
Celje, , Slovenia
Patchogue, New York, United States
Bradenton, Florida, United States
Caen, , France
Vero Beach, Florida, United States
Cordoba, , Argentina
Poissy, , France
Thessaloniki, , Greece
Katowice, , Poland
Targu Mures, , Romania
Rosebank, , South Africa
Stockholm, , Sweden
Samsun, , Turkey
Pune, Maharashtra, India
Merrillville, Indiana, United States
Patchogue, New York, United States
Sherman, Texas, United States
Shanghai, , China
Maitland, Florida, United States
Colorado Springs, Colorado, United States
Wuhan, Hubei, China
Leiria, , Portugal
Columbus, Ohio, United States
Varazdin, Hrv, Croatia
Messina, Me, Italy
New Delhi, Delhi, India
Sofia, , Bulgaria
Chihuahua, , Mexico
Naples, Florida, United States
Suwanee, Georgia, United States
Owosso, Michigan, United States
Greer, South Carolina, United States
Indian Land, South Carolina, United States
Knoxville, Tennessee, United States
Guaynabo, , Puerto Rico
Bratislava, , Slovakia
Albacete, Castilla La Mancha, Spain
Tallinn, , Estonia
Krakow, , Poland
Stamford, Connecticut, United States
Isehara, Kanagawa, Japan
Kyoto City, Kyoto, Japan
Limoges, , France
Kodaira, Tokyo, Japan
Joinville, Santa Catarina, Brazil
Taiyuan, Shanxi, China
Shinjuku Ku, Tokyo, Japan
Braga, , Portugal
Coimbra, , Portugal
Lisboa, , Portugal
Suceava, , Romania
Vero Beach, Florida, United States
Inverness, Invernesshire, United Kingdom
Toulon Cedex 9, Val De Marne, France
Houston, Texas, United States
Kashihara City, Nara, Japan
Lerida, Cataluna, Spain
Marseille, , France
Wenzhou, Zhejiang, China
Sherman, Texas, United States
Contamine Sur Arve, , France
Logrono, La Rioja, Spain
Tartu, , Estonia
Kolkata, West Bengal, India
Koriyama City, Fukushima, Japan
Ichihara City, Chiba, Japan
Ciudad De Mexico, Distrito Federal, Mexico
Buenos Aires, , Argentina
London, , United Kingdom
Knoxville, Tennessee, United States
Frederick, Maryland, United States
Torrejon De Ardoz, Madrid, Spain
El Paso, Texas, United States
Glogow, , Poland
Wroclaw, , Poland
Matosinhos, Porto, Portugal
Santa Maria Da Feira, , Portugal
Winter Park, Florida, United States
Banska Bystrica, , Slovakia
Matosinhos, , Portugal
Sapporo City, Hokkaido, Japan
Sendai City, Miyagi, Japan
Boca Raton, Florida, United States
Frisco, Texas, United States
Orlando, Florida, United States
Temple, Texas, United States
Bradenton, Florida, United States
Vitoria Gasteiz, País Vasco, Spain
Yinchuan, Ningxia, China
Vitoria, Es, Brazil
West Hollywood, California, United States
Split, Hrv, Croatia
Sancaktepe, Istanbul, Turkey
Fukuoka, , Japan
Moriguchi, Osaka, Japan
Nantes, Cedex 1, France
Gonesse, , France
Grenoble, , France
Pembroke Pines, Florida, United States
Montreal, Quebec, Canada
Firenze, Fi, Italy
Modena, Mo, Italy
Levis, Quebec, Canada
Hanford, California, United States
Crab Orchard, West Virginia, United States
Gijon, Asturias, Spain
Foggia, Fg, Italy
Naples, Florida, United States
Curitiba, Pr, Brazil
Suita, Osaka, Japan
Vukovar, , Croatia
Amyntaio, , Greece
Porto Alegre, Rs, Brazil
Amritsar, Punjab, India
Queretaro, , Mexico
Bombal, Mendoza, Argentina
Houston, Texas, United States
Jacksonville, Florida, United States
New Orleans, Louisiana, United States
Pendik Istanbul, , Turkey
Bursa, , Turkey
Limoges, Haute Vienne, France
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Frisco, Texas, United States
San Miguel De, Tucuman, Argentina
Brasilia, Df, Brazil
Sao Paulo, , Brazil
Athens, Attica, Greece
Lucknow, Uttar Pradesh, India
Plewiska, Poznan, Poland
Bialystok, , Poland
Campulung Muscel, Rom, Romania
Constanta, Rom, Romania
Kayseri, , Turkey
Greece, , Greece
St Jerome, Quebec, Canada
Vitoria Gasteiz, Pais Vasco, Spain
Sagamihara, Kanagawa, Japan
Boston, Massachusetts, United States
Greenville, South Carolina, United States
Suwanee, Georgia, United States
Phoenix, Arizona, United States
Guaynabo, , Puerto Rico
Aurora, Colorado, United States
Milwaukee, Wisconsin, United States
Bradenton, Florida, United States
Chiba, , Japan
Lisboa, , Portugal
Pensacola, Florida, United States
Greenville, South Carolina, United States
El Paso, Texas, United States
San Antonio, Texas, United States
Hanford, California, United States
Denver, Colorado, United States
Washington, District Of Columbia, United States
Boca Raton, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Naples, Florida, United States
Pembroke Pines, Florida, United States
Pensacola, Florida, United States
Port Orange, Florida, United States
Vero Beach, Florida, United States
Merrillville, Indiana, United States
Kansas City, Kansas, United States
Nicholasville, Kentucky, United States
Frederick, Maryland, United States
Owosso, Michigan, United States
Patchogue, New York, United States
Charlotte, North Carolina, United States
Columbus, Ohio, United States
Dayton, Ohio, United States
Indian Land, South Carolina, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Seattle, Washington, United States
Seattle, Washington, United States
Crab Orchard, West Virginia, United States
Kochi, Kerala, India
Higashimatsuyama, Saitama, Japan
Brasov, Rom, Romania
Malaga, , Spain
Meram, , Turkey
Dayton, Ohio, United States
San Antonio, Texas, United States
Port Jefferson Station, New York, United States
Campulung Muscel, , Romania
Kobe Shi, , Japan
Shinjuku Ku, Tokyo, Japan
Guaynabo, , Puerto Rico
Chapel Hill, North Carolina, United States
Nicholasville, Kentucky, United States
Port Jefferson Station, New York, United States
Indian Land, South Carolina, United States
Dallas, Texas, United States
Ichihara, Chiba, Japan
Knoxville, Tennessee, United States
Kobe Shi, , Japan
Miami, Florida, United States
Chaidari, Attiki, Greece
Baggiovara, Mo, Italy
Patients applied
Trial Officials
Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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