RightFit
RecruitingPhase 3

Efficacy and Safety of Remibrutinib After Switching From Ocrelizumab in Participants Living With Relapsing Multiple Sclerosis.

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 24 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well remibrutinib works and how safe and easy to tolerate it is after switching from ocrelizumab. It compares switching with staying on ocrelizumab in adults ages 40 to 70 with relapsing multiple sclerosis (MS), a form of MS with symptoms that come back.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 40 to 70 years old.
  • You have relapsing MS diagnosed using the 2017 McDonald rules for diagnosing MS.
  • You take ocrelizumab at the standard dose as part of your usual care.
  • Your brain and nerve symptoms have been stable for the past 30 days.
  • Switching to remibrutinib is suitable based on your doctor's judgment or your preference.

Who can't join

  • You have primary progressive MS, a form of MS that steadily gets worse.
  • You have a history of a serious brain, spinal cord, or other nerve disorder.
  • You have had confirmed progressive multifocal leukoencephalopathy (PML), a serious brain infection, or nerve symptoms that fit this condition.
  • You have an active, serious infection affecting your body, or an ongoing immune system disease other than MS.
  • You have severe heart disease or important abnormal results on an ECG, a test of your heart's electrical activity.
  • You cannot have an MRI scan, which uses magnets to take pictures inside your body.
  • You have had a life-threatening reaction to an ocrelizumab infusion or injection.
  • Ocrelizumab is not controlling your condition well enough, shown by a CD19+ B-cell count of 10 cells per microliter or more at screening. B cells are a type of immune cell.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 * Participants not adequately controlled on ocrelizumab (CD19+ B-cell count ≥10 cells/µL at screening) Other inclusion and exclusion criteria may apply

Study sites (44)

AZ

CA

DC

FL

IL

KS

MA

MD

MI

MO

NC

ND

NJ

NM

NV

NY

OH

OR

SC

TN

TX

VA

WI