ACTIVE_NOT_RECRUITING

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

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Conditions

Relapsing Multiple SclerosisMSRMSRRMSactive secondary progressive multiple sclerosis SPMSremibrutinibLOU064teriflunomideadultrelapseExpanded Disability Status ScaleT2 lesionsT1 lesionsGD- enhancing MRINeurofilament light chainMcDonald diagnostic criteria

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2021-12-13
Study Completion:2030-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05156281

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * 18 to 55 years of age
  2. * Diagnosis of RMS according to the 2017 McDonald diagnostic criteria
  3. * 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.
  4. * EDSS score of 0 to 5.5 (inclusive)
  5. * Neurologically stable within 1 month
  1. * Diagnosis of primary progressive multiple sclerosis (PPMS)
  2. * Disease duration of more than 10 years in participants with EDSS score of 2 or less at screening
  3. * History of clinically significant CNS disease other than MS
  4. * Ongoing substance abuse (drug or alcohol)
  5. * History of malignancy of any organ system (other than complete resection of localized basal cell carcinoma of the skin or in situ cervical cancer),
  6. * Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or Neurological symptoms consistent with PML
  7. * suicidal ideation or behavior
  8. * 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
  9. * Participants who have had a splenectomy
  10. * Active clinically significant systemic bacterial, viral, parasitic or fungal infections
  11. * Positive results for syphilis or tuberculosis testing
  12. * Uncontrolled disease states, such as asthma, or inflammatory bowel disease, where flares are commonly treated with oral or parenteral corticosteroids
  13. * 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.
  14. * Participants with a known immunodeficiency syndrome (AIDS, hereditary immune deficiency, drug induced immune deficiency), or tested positive for HIV antibody
  15. * 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.
  16. * History of severe renal disease or creatinine level
  17. * Participants at risk of developing or having reactivation of hepatitis
  18. * Hematology parameters at screening:
  19. * Hemoglobin: \< 10 g/dl (\<100g/L)
  20. * Platelets: \< 100000/mm3 (\<100 x 109/L)
  21. * Absolute lymphocyte count \< 800/mm3 (\<0.8 x 109/L)
  22. * White blood cells: \<3 000/mm3 (\<3.0 x 109/L)
  23. * Neutrophils: \< 1 500/mm3 (\<1.5 x 109/L)
  24. * 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)
  25. * History or current diagnosis of significant ECG abnormalities
  26. * Resting QTcF ≥450 msec (male) or ≥460 msec (female) at pre-treatment as per central ECG reading at screening visit
  27. * Use of other investigational drugs
  28. * Requirement for anticoagulant medication or use of dual anti-platelet therapy Significant bleeding risk or coagulation disorders,
  29. * History of gastrointestinal bleeding
  30. * Major surgery within 8 weeks prior to screening
  31. * History of hypersensitivity to any of the study drugs or excipients
  32. * Pregnant or nursing (lactating) female participants, prior to randomization
  33. * Women of childbearing potential not using highly effective contraception
  34. * Sexually active males not agreeing to use condom
  35. * Have received any live or live-attenuated vaccines within 6 weeks of randomization or requirement to receive these vaccinations during study
  36. * Use of strong CYP3A4 inhibitors or use of moderate or strong CYP3A4 inducers within two weeks prior to randomization

Contacts and Locations

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

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
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
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
Medical Uni of South Carolina
Charleston, South Carolina, 29425
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

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-13
Study Completion Date2030-10-30

Study Record Updates

Study Start Date2021-12-13
Study Completion Date2030-10-30

Terms related to this study

Keywords Provided by Researchers

  • MS
  • RMS
  • RRMS
  • active secondary progressive multiple sclerosis SPMS
  • remibrutinib
  • LOU064
  • teriflunomide
  • adult
  • relapse
  • Expanded Disability Status Scale
  • T2 lesions
  • T1 lesions
  • GD- enhancing MRI
  • Neurofilament light chain
  • McDonald diagnostic criteria

Additional Relevant MeSH Terms

  • Relapsing Multiple Sclerosis