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)
Annualized relapse rate (ARR) of confirmed relapses [Core Part] — From Baseline, up to 30 months ARR is the average number of confirmed MS relapses in a year
Trial sites (223)
Facility
City
Region
Status
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.
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.
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