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New pill could tame MS relapses

NCT ID NCT05147220

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This Phase 3 trial tests remibrutinib, an oral tablet, against teriflunomide in 1000 adults with relapsing multiple sclerosis. The goal is to see if remibrutinib better reduces yearly relapse rates and delays disability. Participants will then have the option to continue remibrutinib in an open-label extension.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
remibrutinib (tablet)
What this could lead to
If successful, remibrutinib could offer a new, effective oral option to control relapses and slow disability in multiple sclerosis.
What could go wrong
This is a Phase 3 trial, but results are not yet published. Remibrutinib may not prove superior to teriflunomide, and side effects are still being studied.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,000 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Charcot-Marie-Tooth disease type 1F Recurrence relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Relapsing multiple sclerosis

Contacts and locations

Locations

  • AZ Integrated Neuro and Spine

    Phoenix, Arizona, 85037, United States

  • Accel Research Sites St Pete-Largo

    Seminole, Florida, 33777, United States

  • Alpine Clinical Research Center

    Boulder, Colorado, 80301, United States

  • American Oncology Partners PA Center for Cancer and Blood Disorders

    Bethesda, Maryland, 20817, United States

  • Arrow Clinical Trials

    Daytona Beach, Florida, 32117, United States

  • Center for Neurosciences

    Tucson, Arizona, 85718, United States

  • Christiana Care Health Services

    Newark, Delaware, 19713, United States

  • College Park Family Care Center

    Overland Park, Kansas, 66210, United States

  • Columbus Neuroscience

    Westerville, Ohio, 43082, United States

  • Comprehensive Neurology Clinic

    Orlando, Florida, 32825, United States

  • Conquest Research

    Winter Park, Florida, 32789, United States

  • DHR Health Institute

    McAllen, Texas, 78504, United States

  • Glendale Adventist Medical Center

    Glendale, California, 91206, United States

  • Hoag Health System

    Newport Beach, California, 92663, United States

  • Homestead Assoc In Research Inc

    Homestead, Florida, 33033, United States

  • IU Health Inc

    Fort Wayne, Indiana, 46815, United States

  • Jersey Shore University Medical Ctr

    Neptune City, New Jersey, 07753, United States

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104, United States

  • MS Center of Greater Washington, P.C.

    Vienna, Virginia, 22182, United States

  • Multiple Sclerosis Center of Excellence of OMRF

    Oklahoma City, Oklahoma, 73104, United States

  • NYU Langone Med Center CV Research

    New York, New York, 10016, United States

  • Neuro Center

    Pomona, California, 91767, United States

  • Neuro Eye Clinical Trials Inc

    Houston, Texas, 77074, United States

  • Neurological Associates of Long Island PC

    Lake Success, New York, 11042, United States

  • Neurological Services of Orlando PA

    Orlando, Florida, 32806, United States

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174, United States

  • Neurology Center of New England PC

    Foxborough, Massachusetts, 02035, United States

  • Neurology of Central FL Res Ctr

    Altamonte Springs, Florida, 32714, United States

  • Neuroscience Group

    Neenah, Wisconsin, 54956, United States

  • Neurostudies Inc

    Port Charlotte, Florida, 33952, United States

  • Norton Neurology MS Services

    Louisville, Kentucky, 40207, United States

  • Novartis Investigative Site

    Capital Federal, Buenos Aires, 1424, Argentina

  • Novartis Investigative Site

    Rosario, Santa Fe Province, 2000, Argentina

  • Novartis Investigative Site

    Santiago del Estero, Santiago del Estero Province, 4200, Argentina

  • Novartis Investigative Site

    Buenos Aires, C1055AAF, Argentina

  • Novartis Investigative Site

    Caba, C1182, Argentina

  • Novartis Investigative Site

    Caba, C1424BYD, Argentina

  • Novartis Investigative Site

    Capital Federal, C1023AAB, Argentina

  • Novartis Investigative Site

    Linz, Upper Austria, 4020, Austria

  • Novartis Investigative Site

    Linz, 4020, Austria

  • Novartis Investigative Site

    Brussels, Brussels Capital, 1070, Belgium

  • Novartis Investigative Site

    Bruges, 8000, Belgium

  • Novartis Investigative Site

    Edegem, 2650, Belgium

  • Novartis Investigative Site

    Melsbroek, 1820, Belgium

  • Novartis Investigative Site

    Overpelt, 3900, Belgium

  • Novartis Investigative Site

    Porto Alegre, Porto Alegre RS, 90610 000, Brazil

  • Novartis Investigative Site

    Santo André, São Paulo, 09040 010, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 01244-030, Brazil

  • Novartis Investigative Site

    São Paulo, São Paulo, 04076-004, Brazil

  • Novartis Investigative Site

    São Paulo, 01321001, Brazil

  • Novartis Investigative Site

    São Paulo, 04550-000, Brazil

  • Novartis Investigative Site

    Pleven, 5800, Bulgaria

  • Novartis Investigative Site

    Sofia, 1113, Bulgaria

  • Novartis Investigative Site

    Sofia, 1431, Bulgaria

  • Novartis Investigative Site

    Sofia, 1680, Bulgaria

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 7650568, Chile

  • Novartis Investigative Site

    Santiago, Santiago Metropolitan, 8431657, Chile

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510030, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450003, China

  • Novartis Investigative Site

    Changsha, Hunan, 410008, China

  • Novartis Investigative Site

    Baotou, Inner Mongolia, 014040, China

  • Novartis Investigative Site

    Hohhot, Inner Mongolia, 010017, China

  • Novartis Investigative Site

    Nanchang, Jiangxi, 330006, China

  • Novartis Investigative Site

    Changchun, Jilin, 130021, China

  • Novartis Investigative Site

    Beijing, 100053, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Chongqing, 400016, China

  • Novartis Investigative Site

    Tianjin, 300052, China

  • Novartis Investigative Site

    Puerto Colombia, Atlántico, 080012, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760001, Colombia

  • Novartis Investigative Site

    Cali, Valle del Cauca Department, 760032, Colombia

  • Novartis Investigative Site

    Bogotá, 111411, Colombia

  • Novartis Investigative Site

    Medellín, 050001, Colombia

  • Novartis Investigative Site

    Medellín, 050034, Colombia

  • Novartis Investigative Site

    Zagreb, Croatia, 10000, Croatia

  • Novartis Investigative Site

    Osijek, 31000, Croatia

  • Novartis Investigative Site

    Rijeka, 51000, Croatia

  • Novartis Investigative Site

    Zagreb, 10000, Croatia

  • Novartis Investigative Site

    Slagelse, 4200, Denmark

  • Novartis Investigative Site

    Tbilisi, 0100, Georgia

  • Novartis Investigative Site

    Tbilisi, 0114, Georgia

  • Novartis Investigative Site

    Tbilisi, 0159, Georgia

  • Novartis Investigative Site

    Tbilisi, 0178, Georgia

  • Novartis Investigative Site

    Tbilisi, 0179, Georgia

  • Novartis Investigative Site

    Tbilisi, 0192, Georgia

  • Novartis Investigative Site

    Tbilisi, 172, Georgia

  • Novartis Investigative Site

    Guatemala City, 01015, Guatemala

  • Novartis Investigative Site

    Shatin, 999077, Hong Kong

  • Novartis Investigative Site

    Mangalore, Karnataka, 575003, India

  • Novartis Investigative Site

    Mangalore, Karnataka, 575018, India

  • Novartis Investigative Site

    Mumbai, Maharashtra, 400008, India

  • Novartis Investigative Site

    Nashik, Maharashtra, 422005, India

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Novartis Investigative Site

    Chandigarh, Punjab, 160012, India

  • Novartis Investigative Site

    Ludhiana, Punjab, 141008, India

  • Novartis Investigative Site

    Lucknow, Uttar Pradesh, 226014, India

  • Novartis Investigative Site

    Dehradun, Uttarakhand, 248001, India

  • Novartis Investigative Site

    Dublin, Ireland, D03 VX82, Ireland

  • Novartis Investigative Site

    Dublin, DO4, Ireland

  • Novartis Investigative Site

    Ashkelon, 7830604, Israel

  • Novartis Investigative Site

    Hadera, 3820302, Israel

  • Novartis Investigative Site

    Haifa, 3109601, Israel

  • Novartis Investigative Site

    Jerusalem, 9112001, Israel

  • Novartis Investigative Site

    Sefad, 1311300, Israel

  • Novartis Investigative Site

    Milan, MI, 20132, Italy

  • Novartis Investigative Site

    Roma, RM, 00133, Italy

  • Novartis Investigative Site

    Roma, RM, 00168, Italy

  • Novartis Investigative Site

    Roma, RM, 00189, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Novara, 28100, Italy

  • Novartis Investigative Site

    Amman, 11942, Jordan

  • Novartis Investigative Site

    Riga, LV, LV-1005, Latvia

  • Novartis Investigative Site

    Riga, LV 1002, Latvia

  • Novartis Investigative Site

    El Chouf, LBN, 1503-2010, Lebanon

  • Novartis Investigative Site

    Beirut, 166830, Lebanon

  • Novartis Investigative Site

    Tripoli, 1434, Lebanon

  • Novartis Investigative Site

    Šiauliai, LTU, 76231, Lithuania

  • Novartis Investigative Site

    Klaipėda, LT-92288, Lithuania

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586, Malaysia

  • Novartis Investigative Site

    Seberang Jaya, Pulau Pinang, 13700, Malaysia

  • Novartis Investigative Site

    Kuching, Sarawak, 93586, Malaysia

  • Novartis Investigative Site

    Kuala Terengganu, Terengganu, 20400, Malaysia

  • Novartis Investigative Site

    Guadalajara, Jalisco, 44600, Mexico

  • Novartis Investigative Site

    San Pedro G G, 66278, Mexico

  • Novartis Investigative Site

    Veracruz, 91900, Mexico

  • Novartis Investigative Site

    Rotterdam, South Holland, 3079 DZ, Netherlands

  • Novartis Investigative Site

    Wroclaw, Lower Silesian Voivodeship, 52-416, Poland

  • Novartis Investigative Site

    Bydgoszcz, Woj Kujawsko Pomorskie, 85-796, Poland

  • Novartis Investigative Site

    Kielce, 25 726, Poland

  • Novartis Investigative Site

    Lodz, 90 324, Poland

  • Novartis Investigative Site

    Lodz, 93-113, Poland

  • Novartis Investigative Site

    Lublin, 20-410, Poland

  • Novartis Investigative Site

    Piotrkow Trybunalski, 97-300, Poland

  • Novartis Investigative Site

    Poznan, 60-693, Poland

  • Novartis Investigative Site

    Rzeszów, 35-323, Poland

  • Novartis Investigative Site

    Szczecin, 70-111, Poland

  • Novartis Investigative Site

    Riyadh, 11426, Saudi Arabia

  • Novartis Investigative Site

    Bratislava, Slovakia, 826 06, Slovakia

  • Novartis Investigative Site

    Trnava, Slovakia, 917 02, Slovakia

  • Novartis Investigative Site

    Košice, 041 90, Slovakia

  • Novartis Investigative Site

    Nitra, 950 01, Slovakia

  • Novartis Investigative Site

    Cadiz, Andalusia, 11009, Spain

  • Novartis Investigative Site

    Seville, Andalusia, 41014, Spain

  • Novartis Investigative Site

    Barcelona, Barcelona, 08035, Spain

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970, Spain

  • Novartis Investigative Site

    Salt, Girona, 17190, Spain

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922, Spain

  • Novartis Investigative Site

    Getafe, Madrid, 28905, Spain

  • Novartis Investigative Site

    Majadahonda, Madrid, 28222, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Vigo, Pontevedra, 36212, Spain

  • Novartis Investigative Site

    Castilleja de la Cuesta, Sevilla, 41950, Spain

  • Novartis Investigative Site

    A Coruña, 15006, Spain

  • Novartis Investigative Site

    Córdoba, 14004, Spain

  • Novartis Investigative Site

    Las Palmas GC, 35010, Spain

  • Novartis Investigative Site

    León, 24080, Spain

  • Novartis Investigative Site

    Madrid, 28006, Spain

  • Novartis Investigative Site

    Madrid, 28034, Spain

  • Novartis Investigative Site

    Madrid, 28040, Spain

  • Novartis Investigative Site

    Málaga, 29010, Spain

  • Novartis Investigative Site

    Valladolid, 47011, Spain

  • Novartis Investigative Site

    Basel, 4031, Switzerland

  • Novartis Investigative Site

    Bern, 3010, Switzerland

  • Novartis Investigative Site

    Kaohsiung City, 83301, Taiwan

  • Novartis Investigative Site

    Tainan, 704302, Taiwan

  • Novartis Investigative Site

    Taipei, 11220, Taiwan

  • Novartis Investigative Site

    Taoyuan, 33305, Taiwan

  • Novartis Investigative Site

    Ankara, Bilkent-Cankaya, 06800, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, Karsiyaka, 35575, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, Sultangazi, 34295, Turkey (Türkiye)

  • Novartis Investigative Site

    Ankara, Yenimahalle, 06500, Turkey (Türkiye)

  • Novartis Investigative Site

    Mersin, Yenisehir, 33110, Turkey (Türkiye)

  • Novartis Investigative Site

    Istanbul, 34147, Turkey (Türkiye)

  • Novartis Investigative Site

    Izmir, 35100, Turkey (Türkiye)

  • Novartis Investigative Site

    Abu Dhabi, United Arab Emirates

  • Novartis Investigative Site

    Dubai, United Arab Emirates

  • Novartis Investigative Site

    Westbruy on Trym, Bristol, BS10 5NB, United Kingdom

  • Novartis Investigative Site

    Winchester, Hampshire, SO23 8SR, United Kingdom

  • Novartis Investigative Site

    Glasgow, Scotland, G51 4TF, United Kingdom

  • Orlando Health Clinical Trials

    Orlando, Florida, 32806, United States

  • Palmetto Clinical Research

    Summerville, South Carolina, 29485, United States

  • Providence St Vincent Med Center

    Portland, Oregon, 97225, United States

  • Reading Hospital

    Reading, Pennsylvania, 19611, United States

  • Reliant Medical Research

    Miami, Florida, 33165, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • SC3 Research Pasadena

    Pasadena, California, 91105, United States

  • SCL Health

    Billings, Montana, 59101, United States

  • Saturn Research Solutions LLC

    Plano, Texas, 75024, United States

  • Texas Neurology

    Dallas, Texas, 75206, United States

  • The Belinga Clinic

    Fort Smith, Arkansas, 72916, United States

  • The MS Center for Innovation in Care

    St Louis, Missouri, 63131, United States

  • The Neurological Institute PA

    Charlotte, North Carolina, 28204, United States

  • The Neuron Clinic

    Chula Vista, California, 91910, United States

  • The Research and Education Inst of Alta Bates Summit Med Grp

    Berkeley, California, 94705, United States

  • University Of Pittsburgh Medical Ctr Magee-Womens Hospital

    Pittsburgh, Pennsylvania, 15213, United States

  • University Of South Florida

    Tampa, Florida, 33612, United States

  • University of Wisconsin Madison

    Madison, Wisconsin, 53792, United States

  • Velocity Clinical Research

    Raleigh, North Carolina, 27607, United States

  • Washington Hospital Center

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

  • Wayne State University Multiple Sclerosis Clinic

    Detroit, Michigan, 48201, United States

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