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REMODEL II

  • Status
    Accepting Candidates
  • Age
    18 Years - 55 Years
  • Sexes
    All
  • Healthy Volunteers
    No

Objective

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

Description

The study CLOU064C12302 consists of an initial Core Part (CP) (maximum duration per participant of up to 30 months), followed by an Extension Part (EP, of up to 5 years duration) for eligible participants.

The Core Part is a randomized, double-blind, double-dummy, active comparator-controlled, fixed-dose, parallel-group, multi-center study in approximately 800 participants with relapsing multiple sclerosis (RMS).

The Extension Part is an open-label, single-arm, fixed-dose design in which eligible participants are treated with remibrutinib for up to 5 years.

A second study of identical design (CLOU064C12301) will be conducted simultaneously. Both studies will be conducted globally and data from the two studies will be pooled for some of the endpoints.

Details

Full study 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
Protocol number OCR43021
ClinicalTrials.gov ID NCT05156281
Phase Phase 3

Eligibility

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 or hepatic failure or participants with moderate or severe hepatic impairment (Child-Pugh class C) 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 (

Lead researcher

  • Torge Rempe, MD, PhD
    Neurologist
    Languages: Spanish, German
    Torge Rempe

Participate in a study

Here are some general steps to consider when participating in a research study:

  1. Step
    1

    Contact the research team

    Call or email the research team listed within the specific clinical trial or study to let them know that you're interested. A member of the research team, such as the researcher or study coordinator, will be available to tell you more about the study and to answer any questions or concerns you may have.

    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

    You may be asked to take part in prescreening to make sure you are eligible for a study. The prescreening process ensures it is safe for you to participate. During the prescreening process, you will be asked some questions and you may also be asked to schedule tests or procedures to confirm your eligibility.

  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

    If you decide to participate in a clinical trial or study, the research team will keep you informed of the study requirements and what you will need to do to throughout the study. For some trials or studies, your health care provider may work with the research team to ensure there are no conflicts with other medications or treatments.