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Efficacy and safety of remibrutinib after switching from ocrelizumab in participants living with relapsing multiple sclerosis, followed by open-label treatment with remibrutinib.
EU CTIS ID: 2023-509275-17-00
What this study is testing
To demonstrate that remibrutinib is non-inferior to ocrelizumab in controlling inflammatory activity on magnetic resonance imaging (MRI) after switching from ocrelizumab.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent obtained prior to any assessment performed (confirm at Screening Visit).
- Male or female aged 40 (Commercially confidential information) at Screening.
- Diagnosis of RMS according to the revised 2017 McDonald criteria at Screening.
- EDSS score of (Commercially confidential information) at Screening and randomization.
- Treated with ocrelizumab according to routine clinical practice and at standard doses (Commercially confidential information).
- Neurologically stable within 30 days prior to Screening and randomization (including no MS relapse in this period).
You likely can't join if
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria at Screening.
- Participants who have had a splenectomy.
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections in the judgement of the investigator prior to randomization (e.g. infections requiring hospitalization or i.v. antibiotics)
- 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 (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, or drug induced immune deficiency other than those caused by anti-CD20 therapy), or tested positive for human immunodeficiency virus (HIV) antibody, at Screening.
- Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) A, B, C, and E indicating acute or chronic infection: - anti-HA Immunoglobulin (Ig) M (IgM) - HB surface Antigen (HBs Ag) and/or anti-HBc IgM and/or HB virus deoxyribonucleic acid (DNA) - anti-HBc positive - anti-HC IgG (if positive IgG, HC Virus (HCV)-RNA Polymerase Chain Reaction (PCR) will be performed and if negative, participant can be randomized) - anti-HE IgM positive (regardless of IgG status)
See the full eligibility criteria
Who can join
- Signed informed consent obtained prior to any assessment performed (confirm at Screening Visit).
- Male or female aged 40 (Commercially confidential information) at Screening.
- Diagnosis of RMS according to the revised 2017 McDonald criteria at Screening.
- EDSS score of (Commercially confidential information) at Screening and randomization.
- Treated with ocrelizumab according to routine clinical practice and at standard doses (Commercially confidential information).
- Neurologically stable within 30 days prior to Screening and randomization (including no MS relapse in this period).
- Suitable to be switched to remibrutinib based on physician judgement or patient preference.
What rules you out
- Diagnosis of primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald criteria at Screening.
- Participants who have had a splenectomy.
- Active clinically significant systemic bacterial, viral, parasitic or fungal infections in the judgement of the investigator prior to randomization (e.g. infections requiring hospitalization or i.v. antibiotics)
- 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 (acquired immunodeficiency syndrome (AIDS), hereditary immune deficiency, or drug induced immune deficiency other than those caused by anti-CD20 therapy), or tested positive for human immunodeficiency virus (HIV) antibody, at Screening.
- Participants at risk of developing or having reactivation of hepatitis: Positive results at Screening for serological markers for hepatitis (H) A, B, C, and E indicating acute or chronic infection: - anti-HA Immunoglobulin (Ig) M (IgM) - HB surface Antigen (HBs Ag) and/or anti-HBc IgM and/or HB virus deoxyribonucleic acid (DNA) - anti-HBc positive - anti-HC IgG (if positive IgG, HC Virus (HCV)-RNA Polymerase Chain Reaction (PCR) will be performed and if negative, participant can be randomized) - anti-HE IgM positive (regardless of IgG status)
- Participants with any of the following abnormal hematology laboratory values at Screening: - Hemoglobin: (Commercially confidential information) - Platelets: (Commercially confidential information) - Absolute lymphocyte count (Commercially confidential information) - White blood cells: (Commercially confidential information) - Neutrophils: (Commercially confidential information) - (Commercially confidential information)
- Resting QT interval corrected by Fridericia’s formula (QTcF) ≥ (Commercially confidential information) msec (male) or ≥ (Commercially confidential information) msec (female) at pre-treatment as per central ECG reading at Screening visit.
- Use of exclusionary medication prior to Screening/randomization (as defined in the protocol).
- Use of other investigational drugs within 5 half-lives of Screening; or within 30 days (e.g. small molecules); or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics); whichever is longer; or longer if required by local regulations.
- Significant (Commercially confidential information) at Screening.
- Women of childbearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception and do not donate eggs while taking study treatment and for (Commercially confidential information) after stopping ocrelizumab.
- History of life-threatening infusion or injection reaction related to ocrelizumab, such as acute hypersensitivity or acute respiratory distress syndrome.
- History of clinically significant CNS disease (e.g., stroke, traumatic brain or spinal injury, history or presence of myelopathy) or neurological disorders which may mimic MS at Screening.
- Participants with history of confirmed progressive multifocal leukoencephalopathy (PML) or neurological symptoms consistent with PML prior to randomization.
The study team makes the final eligibility decision.
Where it's taking place
- Canada
- Brazil
- Argentina
- Mexico
- United States
- Australia
- Switzerland
- South Africa
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada; Brazil; Argentina; Mexico; United States; Australia and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.