Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
Launched by NOVARTIS PHARMACEUTICALS · Nov 24, 2021
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating the effectiveness and safety of a new medication called remibrutinib compared to an existing treatment, teriflunomide, for people with relapsing multiple sclerosis (RMS). The study aims to find out if remibrutinib can help manage RMS symptoms better than teriflunomide. Participants in the trial must be between 18 and 55 years old, have been diagnosed with RMS, and have experienced at least one relapse in the past year or two relapses in the last two years. They should also be in a stable condition neurologically for at least a month.
If you or someone you know is eligible, joining the trial could provide access to new treatment options and contribute to important research. Participants will receive either remibrutinib or teriflunomide and will be monitored closely throughout the study to track any changes in their condition and side effects. It's important to know that there are strict guidelines about who can participate, including restrictions based on other medical conditions and treatments. If you’re interested, it’s a good idea to discuss it with a healthcare provider to understand more about the potential benefits and risks.
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
Tampa, Florida, United States
Bronx, New York, United States
Chicago, Illinois, United States
Burlington, Massachusetts, United States
Washington, District Of Columbia, United States
Madison, Wisconsin, United States
Seattle, Washington, United States
Park Ridge, Illinois, United States
Glendale, California, United States
Tampa, Florida, United States
Brasschaat, , Belgium
Madrid, , Spain
Bern, , Switzerland
Kosice, , Slovakia
Fullerton, California, United States
Savannah, Georgia, United States
Osijek, , Croatia
Madrid, , Spain
Newark, Delaware, United States
Napoli, , Italy
Basel, , Switzerland
Chicago, Illinois, United States
Salt Lake City, Utah, United States
Madison, Wisconsin, United States
Bruxelles, , Belgium
Cordoba, Andalucia, Spain
Barcelona, Catalunya, Spain
Baracaldo, Vizcaya, Spain
Taoyuan, , Taiwan
Graz, , Austria
Hong Kong, , Hong Kong
Edegem, , Belgium
Graz, , Austria
Brugge, , Belgium
Jerusalem, , Israel
Milano, Mi, Italy
Malaga, Andalucia, Spain
La Coruna, Galicia, Spain
Barcelona, , Spain
Springfield, Illinois, United States
Billings, Montana, United States
Newport Beach, California, United States
Orlando, Florida, United States
Charlotte, North Carolina, United States
El Paso, Texas, United States
Brussel, , Belgium
Dordrecht, , Netherlands
Summerville, South Carolina, United States
Madrid, , Spain
Port Charlotte, Florida, United States
Park Ridge, Illinois, United States
Overland Park, Kansas, United States
Tampa, Florida, United States
Glendale, California, United States
Roma, Rm, Italy
Valencia, Comunidad Valenciana, Spain
Ankara, , Turkey
Ormond Beach, Florida, United States
Berkeley, California, United States
Boulder, Colorado, United States
Honolulu, Hawaii, United States
Overland Park, Kansas, United States
Saint Louis, Missouri, United States
Raleigh, North Carolina, United States
Oklahoma City, Oklahoma, United States
Seattle, Washington, United States
Zagreb, , Croatia
Summerville, South Carolina, United States
Newark, Delaware, United States
Changsha, Hunan, China
Tianjin, , China
Slagelse, , Denmark
Mumbai, Maharashtra, India
Breda, , Netherlands
Klaipeda, , Lithuania
Antwerpen, , Belgium
Port Charlotte, Florida, United States
Charlotte, North Carolina, United States
Tampa, Florida, United States
Dallas, Texas, United States
Melsbroek, , Belgium
Montichiari, Bs, Italy
Beirut, , Lebanon
Beirut, , Lebanon
Jeddah, , Saudi Arabia
Pleven, , Bulgaria
Beijing, , China
Ashkelon, , Israel
Valladolid, Castilla Y Leon, Spain
Scottsdale, Arizona, United States
Guangzhou, Guangdong, China
Changchun, Jilin, China
Hyderabad, Telangana, India
Lucknow, Uttar Pradesh, India
Glasgow, , United Kingdom
Novara, , Italy
Tucson, Arizona, United States
Ashrafieh, , Lebanon
Madrid, , Spain
Hadera, , Israel
Trnava, , Slovakia
Hong Kong, , China
Kuching, Sarawak, Malaysia
Tel Aviv, , Israel
Sevilla, Andalucia, Spain
Jette, Brussel, Belgium
Verona, Vr, Italy
Tainan, , Taiwan
Rosario, Santa Fe, Argentina
Sofia, , Bulgaria
Nashik, Maharashtra, India
Den Bosch, , Netherlands
El Palmar, Murcia, Spain
Rotterdam, , Netherlands
Kosice, Slovak Republic, Slovakia
New Delhi, Delhi, India
Caba, Buenos Aires, Argentina
Edegem, Antwerpen, Belgium
Sofia, , Bulgaria
Izmir, , Turkey
Pelt, , Belgium
Sefad, , Israel
Kuala Lumpur, Wilayah Persekutuan, Malaysia
Lodz, , Poland
Istanbul, , Turkey
Nanchang, Jiangxi, China
Vienna, Virginia, United States
Bratislava, , Slovakia
Alcorcon, Madrid, Spain
Dubai, , United Arab Emirates
Nitra, , Slovakia
Abu Dhabi, , United Arab Emirates
Baotou, Inner Mongolia, China
Riga, Lv, Latvia
Trnava, , Slovakia
Houston, Texas, United States
Kaohsiung, , Taiwan
Dublin, , Ireland
Chula Vista, California, United States
Tucson, Arizona, United States
Basalt, Colorado, United States
Miami, Florida, United States
Ormond Beach, Florida, United States
Lutherville, Maryland, United States
Foxboro, Massachusetts, United States
Philadelphia, Pennsylvania, United States
Neenah, Wisconsin, United States
Salt Lake City, Utah, United States
Riga, , Latvia
Poznan, , Poland
Saint Petersburg, Florida, United States
Capital Federal, Buenos Aires, Argentina
Klagenfurt, , Austria
Kielce, , Poland
Boulder, Colorado, United States
Haifa, , Israel
Linz, Oberoesterreich, Austria
Reading, Pennsylvania, United States
Chang Chun, Jilin, China
Kuala Lumpur, , Malaysia
Sant Joan Despi, Barcelona, Spain
Getafe, Madrid, Spain
Vigo, Pontevedra, Spain
Fort Worth, Texas, United States
Zadar, , Croatia
New Delhi, Delhi, India
Cali, Valle Del Cauca, Colombia
Guangzhou, Guangdong, China
Leon, , Spain
Chandigarh, Punjab, India
El Chouf, Lbn, Lebanon
Las Palmas De Gran Canaria, , Spain
Scottsdale, Arizona, United States
Buenos Aires, , Argentina
Porto Alegre, Porto Alegre Rs, Brazil
Westbruy On Trym, Bristol, United Kingdom
Dehradun, Uttarakhand, India
Ludhiana, Punjab, India
Cadiz, Andalucia, Spain
Rijeka, Hrv, Croatia
Ciudad Autonoma De Bs As, Buenos Aires, Argentina
Mangalore, , India
Haifa, , Israel
Neenah, Wisconsin, United States
Fort Smith, Arkansas, United States
Hertogenbosch, , Netherlands
Kuala Terengganu, Terengganu, Malaysia
Winter Park, Florida, United States
Orlando, Florida, United States
Dublin, , Ireland
Chongqing, , China
Seberang Jaya, Pulau Pinang, Malaysia
Tripoli, , Lebanon
Bellaire, Texas, United States
Louisville, Kentucky, United States
Castilleja De La Cuesta, Sevilla, Spain
Santiago Del Estero, , Argentina
Westerville, Ohio, United States
Bydgoszcz, Woj Kujawsko Pomorskie, Poland
Salt, Cataluna, Spain
Nitra, , Slovakia
Beijing, Beijing, China
Guangzhou City, Guangdong, China
Zhengzhou, Henan, China
Foxboro, Massachusetts, United States
Boston, Massachusetts, United States
Miami, Florida, United States
Chula Vista, California, United States
Miami, Florida, United States
Hohhot, Inner Mongolia, China
Guatemala, , Guatemala
Mcallen, Texas, United States
Altamonte Springs, Florida, United States
Pasadena, California, United States
Miami, Florida, United States
Bethesda, Maryland, United States
Orlando, Florida, United States
Caba, , Argentina
Ath, , Belgium
Dallas, Texas, United States
Dallas, Texas, United States
Lier, , Belgium
Veracruz, , Mexico
Daytona Beach, Florida, United States
Seminole, Florida, United States
Savannah, Georgia, United States
Fort Wayne, Indiana, United States
Reading, Pennsylvania, United States
Santiago, Region Metropolitana, Chile
Piotrkow Trybunalski, , Poland
Rzeszow, , Poland
Szczecin, , Poland
Winchester, Hampshire, United Kingdom
Wroclaw, Dolnoslaskie, Poland
Fort Smith, Arkansas, United States
Haseki Istanbul, , Turkey
Taipei, , Taiwan
Amman, , Jordan
Puerto Colombia, Atlantico, Colombia
Bogota, , Colombia
Sha Tin, , Hong Kong
Dublin 4, , Ireland
Dallas, Texas, United States
Pomona, California, United States
Tampa, Florida, United States
Lutherville, Maryland, United States
Foxboro, Massachusetts, United States
Saint Louis, Missouri, United States
Oklahoma City, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Plano, Texas, United States
San Pedro Garza Garcia, , Mexico
Medellin, Antioquia, Colombia
Chicago, Illinois, United States
Basalt, Colorado, United States
Honolulu, Hawaii, United States
Raleigh, North Carolina, United States
Westerville, Ohio, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Fort Smith, Arkansas, United States
Berkeley, California, United States
Chula Vista, California, United States
Fullerton, California, United States
Glendale, California, United States
Newport Beach, California, United States
Washington, District Of Columbia, United States
Altamonte Springs, Florida, United States
Orlando, Florida, United States
Seminole, Florida, United States
Chicago, Illinois, United States
Springfield, Illinois, United States
Fort Wayne, Indiana, United States
Bethesda, Maryland, United States
Lutherville, Maryland, United States
Saint Louis, Missouri, United States
Billings, Montana, United States
Neptune, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
Raleigh, North Carolina, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Summerville, South Carolina, United States
Houston, Texas, United States
Mcallen, Texas, United States
Salt Lake City, Utah, United States
Vienna, Virginia, United States
Seattle, Washington, United States
Tbilisi, , Georgia
Tripoli, , Lebanon
Siauliai, Ltu, Lithuania
Lublin, , Poland
Khorais Street, Riyadh, Saudi Arabia
Sao Paulo, Sp, Brazil
Orlando, Florida, United States
Fort Wayne, Indiana, United States
Brooklyn, New York, United States
Pittsburgh, Pennsylvania, United States
Winter Park, Florida, United States
Medellin, , Colombia
Bronx, New York, United States
Homestead, Florida, United States
Homestead, Florida, United States
Detroit, Michigan, United States
Brooklyn, New York, United States
Mersin, , Turkey
Ankara, Cankaya, Turkey
Brooklyn, New York, United States
Orlando, Florida, United States
Basalt, Colorado, United States
Phoenix, Arizona, United States
Fort Wayne, Indiana, United States
New York, New York, United States
El Paso, Texas, United States
Mcallen, Texas, United States
Mangalore, Karnataka, India
Nasik, Maharashtra, India
Salt Lake City, Utah, United States
Ashkelon, , Israel
Slagelse, , Denmark
Hadera, , Israel
Zapopan, Jalisco, Mexico
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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