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ACTIVE NOT RECRUITING

NCT05147220

PHASE3

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)

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

1000

Start Date

2021-12-16

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 (200)

AZ Integrated Neuro and Spine

Phoenix, Arizona, United States

Center for Neurosciences

Tucson, Arizona, United States

The Belinga Clinic

Fort Smith, Arkansas, United States

The Research and Education Inst of Alta Bates Summit Med Grp

Berkeley, California, United States

The Neuron Clinic

Chula Vista, California, United States

Glendale Adventist Medical Center

Glendale, California, United States

Hoag Health System

Newport Beach, California, United States

SC3 Research Pasadena

Pasadena, California, United States

Neuro Center

Pomona, California, United States

Alpine Clinical Research Center

Boulder, Colorado, United States

Christiana Care Health Services

Newark, Delaware, United States

Washington Hospital Center

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

Neurology of Central FL Res Ctr

Altamonte Springs, Florida, United States

Arrow Clinical Trials

Daytona Beach, Florida, United States

Homestead Assoc In Research Inc

Homestead, Florida, United States

Reliant Medical Research

Miami, Florida, United States

Neurological Services of Orlando PA

Orlando, Florida, United States

Orlando Health Clinical Trials

Orlando, Florida, United States

Comprehensive Neurology Clinic

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Neurostudies Inc

Port Charlotte, Florida, United States

Accel Research Sites St Pete-Largo

Seminole, Florida, United States

University Of South Florida

Tampa, Florida, United States

Conquest Research

Winter Park, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

IU Health Inc

Fort Wayne, Indiana, United States

College Park Family Care Center

Overland Park, Kansas, United States

Norton Neurology MS Services

Louisville, Kentucky, United States

American Oncology Partners PA Center for Cancer and Blood Disorders

Bethesda, Maryland, United States

Neurology Center of New England PC

Foxborough, Massachusetts, United States

Wayne State University Multiple Sclerosis Clinic

Detroit, Michigan, United States

The MS Center for Innovation in Care

St Louis, Missouri, United States

SCL Health

Billings, Montana, United States

Jersey Shore University Medical Ctr

Neptune City, New Jersey, United States

Neurological Associates of Long Island PC

Lake Success, New York, United States

NYU Langone Med Center CV Research

New York, New York, United States

The Neurological Institute PA

Charlotte, North Carolina, United States

Velocity Clinical Research

Raleigh, North Carolina, United States

Columbus Neuroscience

Westerville, Ohio, United States

Multiple Sclerosis Center of Excellence of OMRF

Oklahoma City, Oklahoma, United States

Providence St Vincent Med Center

Portland, Oregon, United States

University Of Pittsburgh Medical Ctr Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

Reading Hospital

Reading, Pennsylvania, United States

Palmetto Clinical Research

Summerville, South Carolina, United States

Texas Neurology

Dallas, Texas, United States

John Peter Smith Hospital

Fort Worth, Texas, United States

Neuro Eye Clinical Trials Inc

Houston, Texas, United States

DHR Health Institute

McAllen, Texas, United States

Saturn Research Solutions LLC

Plano, Texas, United States

MS Center of Greater Washington, P.C.

Vienna, Virginia, United States

University of Wisconsin Madison

Madison, Wisconsin, United States

Neuroscience Group

Neenah, Wisconsin, United States

Novartis Investigative Site

Capital Federal, Buenos Aires, Argentina

Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

Novartis Investigative Site

Santiago del Estero, Santiago del Estero Province, Argentina

Novartis Investigative Site

Buenos Aires, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Caba, Argentina

Novartis Investigative Site

Capital Federal, Argentina

Novartis Investigative Site

Linz, Upper Austria, Austria

Novartis Investigative Site

Linz, Austria

Novartis Investigative Site

Brussels, Brussels Capital, Belgium

Novartis Investigative Site

Bruges, Belgium

Novartis Investigative Site

Edegem, Belgium

Novartis Investigative Site

Melsbroek, Belgium

Novartis Investigative Site

Overpelt, Belgium

Novartis Investigative Site

Porto Alegre, Porto Alegre RS, Brazil

Novartis Investigative Site

Santo André, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

São Paulo, Brazil

Novartis Investigative Site

Pleven, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Sofia, Bulgaria

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Santiago, Santiago Metropolitan, Chile

Novartis Investigative Site

Guangzhou, Guangdong, China

Novartis Investigative Site

Zhengzhou, Henan, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Baotou, Inner Mongolia, China

Novartis Investigative Site

Hohhot, Inner Mongolia, China

Novartis Investigative Site

Nanchang, Jiangxi, China

Novartis Investigative Site

Changchun, Jilin, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Beijing, China

Novartis Investigative Site

Chongqing, China

Novartis Investigative Site

Tianjin, China

Novartis Investigative Site

Puerto Colombia, Atlántico, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Cali, Valle del Cauca Department, Colombia

Novartis Investigative Site

Bogotá, Colombia

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Medellín, Colombia

Novartis Investigative Site

Zagreb, Croatia, Croatia

Novartis Investigative Site

Osijek, Croatia

Novartis Investigative Site

Rijeka, Croatia

Novartis Investigative Site

Zagreb, Croatia

Novartis Investigative Site

Slagelse, Denmark

And 100 more locations on ClinicalTrials.gov

Clinical Research Directory

Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS) (REMODEL-1)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (200)