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Clinical Trials in India / NCT05156281
Active, not recruiting Phase 3

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

NCT05156281 · tracked via the Priya Life Science India tracker
Sponsor
Novartis Pharmaceuticals
Phase
Phase 3
Started
2021-12-13
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 (223)

FacilityCityRegionStatus
Ctr for Neurology and Spine Phoenix Arizona
Vladimir Royter MD APMC Hanford California
VA Greater LA Healthcare System Los Angeles California
Regina Berkovich MD PhD Inc West Hollywood California
CU Anschutz Med Campus Aurora Colorado
Colorado Neurological Research PC Denver Colorado
New England Institute for Clinical Research Stamford Connecticut
Georgetown University Hospital Research Washington D.C. District of Columbia
Georgetown University Hospital Washington D.C. District of Columbia
Nova Clinical Research LLC Bradenton Florida
University of Florida Gainesville Florida
Memorial Healthcare System Hollywood Florida
Neurology Associates PA Maitland Florida
Gables Neurology Miami Florida
UM Department Of Neurology Miami Florida
Aqualane Clinical Research Naples Florida
Advent Health Orlando Orlando Florida
Humanity Clinical Research Pembroke Pines Florida
Emerald Coast Neurology Pensacola Florida
Brain and Spine Institute Port Orange Florida
Vero Beach Neurology Vero Beach Florida
Conquest Research Winter Park Florida
Methodist Neuroscience Institute Merrillville Indiana
University of Kansas Hospital Kansas City Kansas
Baptist Physicians Lexington Nicholasville Kentucky
Ochsner Clinic Foundation New Orleans Louisiana
Clinre Comprehensive Neurology Frederick Maryland
Tufts Medical Center Boston Massachusetts
Kansas City VA Medical Center Kansas City Missouri
South Shore Neurologic Associates Patchogue New York
University Of NC At Chapel Hill Chapel Hill North Carolina
Piedmont HealthCare Charlotte North Carolina
The Boster Ctr for MS Columbus Ohio
Neurology Diagnostics Inc Dayton Ohio
Penn State Hershey Medical Center Hershey Pennsylvania
Premier Neurology Greenville South Carolina
Metrolina Neurological Associates PA Old Point Station South Carolina
Sibyl Wray MD Neurology PC Knoxville Tennessee
Neurology Consultants Of Dallas PA Dallas Texas
Med Research Inc El Paso Texas

+ 183 more sites — see the full list on the official registry below.

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 NCT05156281 on ClinicalTrials.gov ↗ ← All trials in India