Efficacy and Safety of Remibrutinib Compared to Teriflunomide in Participants With Relapsing Multiple Sclerosis (RMS)
REMODEL-2
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
2 other identifiers
interventional
1,011
25 countries
205
Brief Summary
To compare the efficacy and safety of remibrutinib versus teriflunomide in patients with relapsing multiple sclerosis (RMS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
Longer than P75 for phase_3
205 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 13, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 30, 2030
ExpectedMarch 30, 2026
March 1, 2026
4.4 years
December 1, 2021
March 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Annualized relapse rate (ARR) of confirmed relapses [Core Part]
ARR is the average number of confirmed MS relapses in a year
From Baseline, up to 30 months
Secondary Outcomes (24)
Time to 3-month confirmed disability progression (3mCDP) on Expanded Disability Status Scale (EDSS) [Core Part] (pooled data)
Baseline up to 30 months
Time to 6-month confirmed disability progression (6mCDP) on EDSS [Core Part] (pooled data)
Baseline up to 30 months
Annualized rate of new or enlarging T2 lesion [Core Part]
Baseline up to 30 months
Neurofilament light chain (Nfl) [Core Part]
Baseline up to 30 months
Number of Gd-enhancing T1 lesions per MRI scan [Core Part]
Baseline up to 30 months
- +19 more secondary outcomes
Study Arms (4)
Remibrutinib - Core
EXPERIMENTALRemibrutinib tablet and matching placebo of teriflunomide capsule
Teriflunomide - Core
ACTIVE COMPARATORTeriflunomide capsule and matching placebo remibrutinib tablet
Remibrutinib - Extension
EXPERIMENTALParticipants on remibrutinib in Core will continue on remibrutinib tablet
Remibrutinib - Extension (on teriflunomide in Core)
EXPERIMENTALParticipants on teriflunomide in Core will switch to remibrutinib tablet
Interventions
tablet taken orally
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (225)
Ctr for Neurology and Spine
Phoenix, Arizona, 85018, United States
Vladimir Royter MD APMC
Hanford, California, 93230, United States
VA Greater LA Healthcare System
Los Angeles, California, 90073, United States
Regina Berkovich MD PhD Inc
West Hollywood, California, 90048, United States
CU Anschutz Med Campus
Aurora, Colorado, 80045, United States
Colorado Neurological Research PC
Denver, Colorado, 80210, United States
New England Institute for Clinical Research
Stamford, Connecticut, 06905, United States
Georgetown University Hospital Research
Washington D.C., District of Columbia, 20007, United States
Georgetown University Hospital
Washington D.C., District of Columbia, 20007, United States
Nova Clinical Research LLC
Bradenton, Florida, 34209, United States
University of Florida
Gainesville, Florida, 32610, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
Neurology Associates PA
Maitland, Florida, 32751, United States
Gables Neurology
Miami, Florida, 33133, United States
UM Department Of Neurology
Miami, Florida, 33136, United States
Aqualane Clinical Research
Naples, Florida, 34105, United States
Advent Health Orlando
Orlando, Florida, 32803, United States
Humanity Clinical Research
Pembroke Pines, Florida, 33024, United States
Emerald Coast Neurology
Pensacola, Florida, 32514, United States
Brain and Spine Institute
Port Orange, Florida, 32127, United States
Vero Beach Neurology
Vero Beach, Florida, 32960, United States
Conquest Research
Winter Park, Florida, 32789, United States
Methodist Neuroscience Institute
Merrillville, Indiana, 46410, United States
University of Kansas Hospital
Kansas City, Kansas, 66160, United States
Baptist Physicians Lexington
Nicholasville, Kentucky, 40356, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Clinre Comprehensive Neurology
Frederick, Maryland, 21702, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Kansas City VA Medical Center
Kansas City, Missouri, 64128, United States
South Shore Neurologic Associates
Patchogue, New York, 11772, United States
True North Neurology
Port Jefferson, New York, 11776, United States
University Of NC At Chapel Hill
Chapel Hill, North Carolina, 27599 9500, United States
Piedmont HealthCare
Charlotte, North Carolina, 28210, United States
The Boster Ctr for MS
Columbus, Ohio, 43235, United States
Neurology Diagnostics Inc
Dayton, Ohio, 45408, United States
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Premier Neurology
Greenville, South Carolina, 29605, United States
Metrolina Neurological Associates PA
Old Point Station, South Carolina, 29707, United States
Sibyl Wray MD Neurology PC
Knoxville, Tennessee, 37922, United States
Neurology Consultants Of Dallas PA
Dallas, Texas, 75231, United States
Med Research Inc
El Paso, Texas, 79935, United States
Lone Star Neurology
Frisco, Texas, 75035, United States
UT Health MARC Medical Arts and Research Center
San Antonio, Texas, 78229, United States
Lonestar Neurology of San Antonio
San Antonio, Texas, 78258, United States
Texas Institute for Neurological Disorders
Sherman, Texas, 75092, United States
Baylor Scott and White
Temple, Texas, 76508, United States
Virginia Mason Medical Centre
Seattle, Washington, 98101, United States
University of Washington MS Clinic
Seattle, Washington, 98133, United States
Elligo Health Research
Crab Orchard, West Virginia, 25827, United States
Ascension St Francis Center
Milwaukee, Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226, United States
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Valencia, Valencia, 46017, Spain
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Barcelona, 08041, Spain
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Lleida, 25198, Spain
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Madrid, 28009, Spain
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- In order to maintain blinding, a double-dummy design will be used
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2021
First Posted
December 14, 2021
Study Start
December 13, 2021
Primary Completion
April 30, 2026
Study Completion (Estimated)
October 30, 2030
Last Updated
March 30, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com