Last Update: Dec 17, 2025
A Randomized, Double-blind, Double-dummy, Parallel-group Study, Comparing the Efficacy and Safety of Remibrutinib Versus Teriflunomide in Participants With Relapsing Multiple Sclerosis, Followed by Extended Treatment With Open-label Remibrutinib
ClinicalTrials.gov Identifier:
Novartis Reference Number:CLOU064C12302
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS) The study CLOU064C12302 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.

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.

Relapsing Multiple Sclerosis
Phase3
Recruiting
800
Dec 13, 2021
Oct 30, 2030
All
18 Years - 55 Years (Adult)

Interventions

Drug

Remibrutinib

tablet taken orally
Drug

Teriflunomide

capsule taken orally

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.

Novartis Investigative Site

Recruiting

Plovdiv,4002,Bulgaria

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Sofia,1309,Bulgaria

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Sofia,1407,Bulgaria

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Sofia,1431,Bulgaria

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Saint-Jérôme,Quebec,J7z 5t3,Canada

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Shanghai,200025,China

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Nanjing,Jiangsu,210029,China

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Hangzhou,Zhejiang,310006,China

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Hangzhou,Zhejiang,310016,China

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Wenzhou,Zhejiang,325000,China

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Shanghai,200040,China

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Tallinn,11315,Estonia

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Nantes,44093,France

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Marseille,13003,France

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Ulm,89073,Germany

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Siegen,57076,Germany

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Essen,45147,Germany

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New Delhi,National Capital Territory of Delhi,110060,India

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Kochi,Kerala,682025,India

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Pune,Maharashtra,411013,India

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Kolkata,West Bengal,700017,India

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Lucknow,Uttar Pradesh,226007,India

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Hyderabad,Telangana,500082,India

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Amritsar,Punjab,143006,India

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Moriguchi,Osaka,570-8507,Japan

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Isehara,Kanagawa,259-1193,Japan

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Shinjuku Ku,Tokyo,160-0023,Japan

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Fukuoka,810-0022,Japan

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Nagoya,Aichi-ken,466 8560,Japan

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Higashi-Matsuyama,Saitama,355-0005,Japan

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Itabashi-ku,Tokyo,1738610,Japan

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Fukuoka,8128582,Japan

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Kyoto,616-8255,Japan

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Katowice,40-689,Poland

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Plewiska,Poznan,62-064,Poland

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Katowice,40-081,Poland

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Wroclaw,51-685,Poland

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Zabrze,41-800,Poland

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Katowice,40-686,Poland

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Recruiting

Katowice,40-571,Poland

Caribbean Center for Clinical Research, Inc

Recruiting

Guaynabo,00968,Puerto Rico

Angel R Chinea Martinez
Viviana Martinez-Maldonado

Novartis Investigative Site

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Barcelona,08041,Spain

Novartis Investigative Site

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Istanbul,Fatih,34098,Turkey (Türkiye)

Sibyl Wray MD Neurology PC

Recruiting

Knoxville,Tennessee,37922,United States

Sibyl Wray
Brenda Whitehead

Medical Uni of South Carolina

Recruiting

Charleston,South Carolina,29425,United States

Alison Line
Andrew P Keegan

Baylor Scott and White

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Temple,Texas,76508,United States

Lokesh Rukmangadachar
Melissa Zdroik

Nova Clinical Research LLC

Recruiting

Bradenton,Florida,34209,United States

Adrian Valdes
Sanjay Yathiraj

VA Greater LA Healthcare System

Recruiting

Los Angeles,California,90073,United States

Andrea Hanssen
Eric Williamson

UM Department Of Neurology

Recruiting

Miami,Florida,33136,United States

Gloria Rodriguez
Silvia R Delgado

Memorial Healthcare System

Recruiting

Hollywood,Florida,33021,United States

Buse Sengul
Thatcher Elyse

Metrolina Neurological Associates PA

Recruiting

Old Point Station,South Carolina,29707,United States

Howard Mandell
Ashley Philbeck

Georgetown University Hospital Research

Recruiting

Washington D.C.,District of Columbia,20007,United States

Faria Amjad
David Pisfil

UT Health MARC Medical Arts and Research Center

Recruiting

San Antonio,Texas,78229,United States

Tania Reyna
Randee Kent-Baron

Gables Neurology

Recruiting

Miami,Florida,33133,United States

Dayana Torres
Andrew Lerman

University of Washington MS Clinic

Recruiting

Seattle,Washington,98133,United States

Elisa McGee
Gloria von Geldern

Lonestar Neurology of San Antonio

Recruiting

San Antonio,Texas,78258,United States

Marie Toue
Ann Bass

Med Research Inc

Recruiting

El Paso,Texas,79935,United States

Moravia Vasallo
Javier Alejandro Vasallo

Kansas City VA Medical Center

Recruiting

Kansas City,Missouri,64128,United States

Vikas Singh
Shamsa Kiran

Methodist Neuroscience Institute

Recruiting

Merrillville,Indiana,46410,United States

William Conte
Sarah Baran

Colorado Neurological Research PC

Recruiting

Denver,Colorado,80210,United States

Susie Mercer
Adam Wolff

CU Anschutz Med Campus

Recruiting

Aurora,Colorado,80045,United States

Enrique Alvarez
Ahmad Abdelrahman

Regina Berkovich MD PhD Inc

Recruiting

West Hollywood,California,90048,United States

Regina Berkovich
Divya Venkataramu

Vladimir Royter MD APMC

Recruiting

Hanford,California,93230,United States

Vladimir Royter
Larisa Royter

Aqualane Clinical Research

Recruiting

Naples,Florida,34105,United States

Jose Sanchez
Matthew J Baker

University Of NC At Chapel Hill

Recruiting

Chapel Hill,North Carolina,27599 9500,United States

Irena Dujmovic Basuroski
Marleny Nolasco

Tufts Medical Center

Recruiting

Boston,Massachusetts,02111,United States

Kristen Babinski
Ashley Paro

Ochsner Clinic Foundation

Recruiting

New Orleans,Louisiana,70121,United States

Sophia Marathonitis
Jenny Feng

Humanity Clinical Research

Recruiting

Pembroke Pines,Florida,33024,United States

Linda S Dolin
Elena Guerrero

Mayo Clinic Jacksonville

Recruiting

Jacksonville,Florida,32224,United States

Vanessa Iris Marin Collazo
Pamela DeSaro

Ascension St Francis Center

Recruiting

Milwaukee,Wisconsin,53215,United States

Tayo Olapo
Bhupendra Khatri

Elligo Health Research

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Crab Orchard,West Virginia,25827,United States

Barry Vaught
Ashley Legursky

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