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Clinical Trials in China / NCT05147220
Active, not recruiting Phase 3

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

NCT05147220 · tracked via the Priya Life Science China tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2021-12-16
Last updated
2026-08-18

Condition(s) studied

Relapsing Multiple Sclerosis

Investigational drug(s) / intervention(s)

RemibrutinibTeriflunomide

Remibrutinib: tablet taken orally

Teriflunomide: capsule taken orally

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (200)

FacilityCityRegionStatus
AZ Integrated Neuro and Spine Phoenix Arizona
Center for Neurosciences Tucson Arizona
The Belinga Clinic Fort Smith Arkansas
The Research and Education Inst of Alta Bates Summit Med Grp Berkeley California
The Neuron Clinic Chula Vista California
Glendale Adventist Medical Center Glendale California
Hoag Health System Newport Beach California
SC3 Research Pasadena Pasadena California
Neuro Center Pomona California
Alpine Clinical Research Center Boulder Colorado
Christiana Care Health Services Newark Delaware
Washington Hospital Center Washington D.C. District of Columbia
Neurology of Central FL Res Ctr Altamonte Springs Florida
Arrow Clinical Trials Daytona Beach Florida
Homestead Assoc In Research Inc Homestead Florida
Reliant Medical Research Miami Florida
Neurological Services of Orlando PA Orlando Florida
Orlando Health Clinical Trials Orlando Florida
Comprehensive Neurology Clinic Orlando Florida
Neurology Associates of Ormond Beach Ormond Beach Florida
Neurostudies Inc Port Charlotte Florida
Accel Research Sites St Pete-Largo Seminole Florida
University Of South Florida Tampa Florida
Conquest Research Winter Park Florida
Rush University Medical Center Chicago Illinois
IU Health Inc Fort Wayne Indiana
College Park Family Care Center Overland Park Kansas
Norton Neurology MS Services Louisville Kentucky
American Oncology Partners PA Center for Cancer and Blood Disorders Bethesda Maryland
Neurology Center of New England PC Foxborough Massachusetts
Wayne State University Multiple Sclerosis Clinic Detroit Michigan
The MS Center for Innovation in Care St Louis Missouri
SCL Health Billings Montana
Jersey Shore University Medical Ctr Neptune City New Jersey
Neurological Associates of Long Island PC Lake Success New York
NYU Langone Med Center CV Research New York New York
The Neurological Institute PA Charlotte North Carolina
Velocity Clinical Research Raleigh North Carolina
Columbus Neuroscience Westerville Ohio
Multiple Sclerosis Center of Excellence of OMRF Oklahoma City Oklahoma

+ 160 more sites — see the full list on the official registry below.

More Novartis Pharmaceuticals trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05147220 on ClinicalTrials.gov ↗ ← All trials in China