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:2021-12-16
Study Completion:2030-10-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05147220

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)

AZ Integrated Neuro and Spine
Phoenix, Arizona, 85037
United States
Honor Health Research Institute
Scottsdale, Arizona, 85258
United States
Center for Neurosciences
Tucson, Arizona, 85718
United States
The Belinga Clinic
Fort Smith, Arkansas, 72916
United States
The Research and Education Inst. of Alta Bates Summit Med. Grp
Berkeley, California, 94705
United States
The Neuron Clinic
Chula Vista, California, 91910
United States
Glendale Adventist Medical Center
Glendale, California, 91206
United States
Hoag Health System
Newport Beach, California, 92663
United States
SC3 Research Pasadena
Pasadena, California, 91105
United States
Neuro Center
Pomona, California, 91767
United States
Alpine Clinical Research Center
Boulder, Colorado, 80301
United States
Christiana Care Health Services
Newark, Delaware, 19713
United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010
United States
Neurology of Central FL Res Ctr
Altamonte Springs, Florida, 32714
United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117
United States
Homestead Assoc In Research Inc
Homestead, Florida, 33033
United States
Reliant Medical Research
Miami, Florida, 33165
United States
Neurological Services of Orlando PA
Orlando, Florida, 32806
United States
Orlando Health Clinical Trials
Orlando, Florida, 32806
United States
Comprehensive Neurology Clinic
Orlando, Florida, 32825
United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, 32174
United States
Neurostudies Inc
Port Charlotte, Florida, 33952
United States
Accel Research Sites St Pete-Largo
Seminole, Florida, 33777
United States
University Of South Florida
Tampa, Florida, 33612
United States
Conquest Research
Winter Park, Florida, 32789
United States
Rush University Medical Center
Chicago, Illinois, 60612
United States
IU Health Inc
Fort Wayne, Indiana, 46815
United States
College Park Family Care Center
Overland Park, Kansas, 66210
United States
Norton Neurology MS Services
Louisville, Kentucky, 40207
United States
American Oncology Partners PA Center for Cancer & Blood Disorders
Bethesda, Maryland, 20817
United States
Beth Israel Deaconess Med Center
Boston, Massachusetts, 02215
United States
Neurology Center of New England PC
Foxborough, Massachusetts, 02035
United States
Wayne State University Multiple Sclerosis Clinic
Detroit, Michigan, 48201
United States
The MS Center for Innovation in Care
St Louis, Missouri, 63131
United States
SCL Health
Billings, Montana, 59101
United States
Jersey Shore University Medical Ctr
Neptune City, New Jersey, 07753
United States
Neurological Associates of Long Island PC
Lake Success, New York, 11042
United States
NYU Langone Med Center CV Research
New York, New York, 10016
United States
Montefiore Medical Center
The Bronx, New York, 10467
United States
The Neurological Institute PA
Charlotte, North Carolina, 28204
United States
Velocity Clinical Research
Raleigh, North Carolina, 27607
United States
Columbus Neuroscience
Westerville, Ohio, 43082
United States
Multiple Sclerosis Center of Excellence of OMRF
Oklahoma City, Oklahoma, 73104
United States
Providence St Vincent Med Center
Portland, Oregon, 97225
United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107-5098
United States
University Of Pittsburgh Medical Ctr Magee-Womens Hospital
Pittsburgh, Pennsylvania, 15213
United States
Reading Hospital
Reading, Pennsylvania, 19611
United States
Palmetto Clinical Research
Summerville, South Carolina, 29485
United States
Texas Neurology
Dallas, Texas, 75206
United States
John Peter Smith Hospital
Fort Worth, Texas, 76104
United States
Neuro Eye Clinical Trials Inc
Houston, Texas, 77074
United States
DHR Health Institute
McAllen, Texas, 78503
United States
Saturn Research Solutions LLC
Plano, Texas, 75024
United States
MS Center of Greater Washington, P.C.
Vienna, Virginia, 22182
United States
University of Wisconsin Madison
Madison, Wisconsin, 53792
United States
Neuroscience Group
Neenah, Wisconsin, 54956
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 Date2021-12-16
Study Completion Date2030-10-30

Study Record Updates

Study Start Date2021-12-16
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