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 (200)
Facility
City
Region
Status
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.
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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