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RESHAPE

  • Status
    Accepting Candidates
  • Age
    40 Years - 70 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The purpose of this Phase 3b study is to assess the efficacy, safety and tolerability of remibrutinib after switching from ocrelizumab and compared to continuous ocrelizumab treatment, in patients living with relapsing multiple sclerosis (plwRMS).

Description

The study is a randomized, open-label, non-inferiority multi-center, Phase 3b study to provide efficacy, safety, and tolerability data for remibrutinib after switching from ocrelizumab and in comparison to continuous ocrelizumab in plwRMS.

This study consists of an initial Core Part (CP) (maximum duration per participant of up to 24 months), followed by an Extension Part (EP) (of up to 24 months duration) for eligible participants.

All participants completing the 24-month treatment of the Core Part of the study may be eligible to continue in the Extension Part, an open-label, single-arm, fixed-dose design in which participants are treated with remibrutinib for up to 24 months.

The study will be conducted in the USA among other countries globally.

Details

Full study title A randomized, open-label, parallel-group, non-inferiority study comparing efficacy, safety, and tolerability of remibrutinib after switching from ocrelizumab in participants living with relapsing multiple sclerosis, followed by open-label treatment with remibrutinib
Protocol number OCR47994
ClinicalTrials.gov ID NCT06846281
Phase Phase 3

Eligibility

Key Inclusion Criteria:

  • Male or female aged 40 to 70 years (inclusive)

  • Diagnosis of RMS according to the 2017 McDonald diagnostic criteria

  • Treated with ocrelizumab according to routine clinical practice and at standard dose

  • Neurologically stable within 30 days

  • Suitable to be switched to remibrutinib based on physician judgement or patient preference

Key Exclusion Criteria:

  • Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria

  • History of clinically significant Central Nervous System disease or neurological disorders

  • History of confirmed Progressive Multifocal Leukoencephalopathy or neurological symptoms consistent

  • Active clinically significant systemic bacterial, viral, parasitic or fungal infections

  • Active, chronic disease of the immune system other than MS

  • Severe cardiac disease or significant findings on the ECG

  • Participant who is unable to undergo MRI scans

  • History of life-threatening infusion or injection reaction related to ocrelizumab

Other inclusion and exclusion criteria may apply

Lead researcher

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

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  1. Step
    1

    Contact the research team

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    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

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  4. Step
    4

    Participate

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