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ACTIVE NOT RECRUITING

NCT05156281

PHASE3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)

Sponsor: Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

1007

Start Date

2021-12-13

Completion Date

2030-10-30

Last Updated

2026-08-18

Healthy Volunteers

Conditions

Relapsing Multiple Sclerosis

Interventions

DRUG

Remibrutinib

tablet taken orally

DRUG

Teriflunomide

capsule taken orally

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.

Locations (223)

Ctr for Neurology and Spine

Phoenix, Arizona, United States

Vladimir Royter MD APMC

Hanford, California, United States

VA Greater LA Healthcare System

Los Angeles, California, United States

Regina Berkovich MD PhD Inc

West Hollywood, California, United States

CU Anschutz Med Campus

Aurora, Colorado, United States

Colorado Neurological Research PC

Denver, Colorado, United States

New England Institute for Clinical Research

Stamford, Connecticut, United States

Georgetown University Hospital Research

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

Georgetown University Hospital

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

Nova Clinical Research LLC

Bradenton, Florida, United States

University of Florida

Gainesville, Florida, United States

Memorial Healthcare System

Hollywood, Florida, United States

Neurology Associates PA

Maitland, Florida, United States

Gables Neurology

Miami, Florida, United States

UM Department Of Neurology

Miami, Florida, United States

Aqualane Clinical Research

Naples, Florida, United States

Advent Health Orlando

Orlando, Florida, United States

Humanity Clinical Research

Pembroke Pines, Florida, United States

Emerald Coast Neurology

Pensacola, Florida, United States

Brain and Spine Institute

Port Orange, Florida, United States

Vero Beach Neurology

Vero Beach, Florida, United States

Conquest Research

Winter Park, Florida, United States

Methodist Neuroscience Institute

Merrillville, Indiana, United States

University of Kansas Hospital

Kansas City, Kansas, United States

Baptist Physicians Lexington

Nicholasville, Kentucky, United States

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Clinre Comprehensive Neurology

Frederick, Maryland, United States

Tufts Medical Center

Boston, Massachusetts, United States

Kansas City VA Medical Center

Kansas City, Missouri, United States

South Shore Neurologic Associates

Patchogue, New York, United States

University Of NC At Chapel Hill

Chapel Hill, North Carolina, United States

Piedmont HealthCare

Charlotte, North Carolina, United States

The Boster Ctr for MS

Columbus, Ohio, United States

Neurology Diagnostics Inc

Dayton, Ohio, United States

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Premier Neurology

Greenville, South Carolina, United States

Metrolina Neurological Associates PA

Old Point Station, South Carolina, United States

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, United States

Neurology Consultants Of Dallas PA

Dallas, Texas, United States

Med Research Inc

El Paso, Texas, United States

Lone Star Neurology

Frisco, Texas, United States

UT Health MARC Medical Arts and Research Center

San Antonio, Texas, United States

Lonestar Neurology of San Antonio

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

Baylor Scott and White

Temple, Texas, United States

Virginia Mason Medical Centre

Seattle, Washington, United States

University of Washington MS Clinic

Seattle, Washington, United States

Elligo Health Research

Crab Orchard, West Virginia, United States

Ascension St Francis Center

Milwaukee, Wisconsin, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Novartis Investigative Site

Bombal, Mendoza Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

San Miguel de, Tucumán Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

CABA, Argentina

Novartis Investigative Site

Córdoba, Argentina

Novartis Investigative Site

Vitória, Espírito Santo, Brazil

Novartis Investigative Site

Brasília, Federal District, Brazil

Novartis Investigative Site

Curitiba, Paraná, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Porto Alegre, Rio Grande do Sul, Brazil

Novartis Investigative Site

Joinville, Santa Catarina, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Plovdiv, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Edmonton, Alberta, Canada

Novartis Investigative Site

Burnaby, British Columbia, Canada

Novartis Investigative Site

Halifax, Nova Scotia, Canada

Novartis Investigative Site

Ottawa, Ontario, Canada

Novartis Investigative Site

Lévis, Quebec, Canada

Novartis Investigative Site

Montreal, Quebec, Canada

Novartis Investigative Site

Québec, Quebec, Canada

Novartis Investigative Site

Saint-Jérôme, Quebec, Canada

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Yinchuan, Ningxia, China

Novartis Investigative Site

Taiyuan, Shanxi, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Wenzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Shanghai, China

Novartis Investigative Site

Zagreb, Croatia, Croatia

Novartis Investigative Site

Split, HRV, Croatia

Novartis Investigative Site

Varaždin, HRV, Croatia

Novartis Investigative Site

Vukovar, Vukovar, Croatia

Novartis Investigative Site

Zagreb, Croatia

Novartis Investigative Site

Brno, Czechia

Novartis Investigative Site

Hradec Králové, Czechia

Novartis Investigative Site

Teplice, Czechia

Novartis Investigative Site

Tallinn, Estonia

Novartis Investigative Site

Tartu, Estonia

Novartis Investigative Site

Limoges, Haute Vienne, France

Novartis Investigative Site

Toulon, Val De Marne, France

And 123 more locations on ClinicalTrials.gov

Clinical Research Directory

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-2)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (223)