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A Study to Evaluate the Efficacy and Safety of Fenebrutinib Compared with Ocrelizumab in Adult Patients with Primary Progressive Multiple Sclerosis
EU CTIS ID: 2022-502611-10-00
What this study is testing
To evaluate the efficacy of fenebrutinib compared with ocrelizumab in patients with PPMS regardless of adherence to randomized treatment
- 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
- Ability to comply with the study protocol
- A diagnosis of PPMS in accordance to the revised 2017 McDonald Criteria
- Disability progression in the 12 months prior to screening, as assessed by the Pre-Baseline Disability Progression Questionnaire
- EDSS score from 3.0 to 6.5 inclusive at screening
- Pyramidal functional subscore ≥ 2 at screening
- For patients currently receiving proton pump inhibitors (PPIs) or H2 receptor antagonists (H2RAs): treatment at a stable dose during the screening period prior to the initiation of study treatment and plans to remain at a stable dose for the duration of study treatment
You likely can't join if
- For patients enrolled in Germany and in Italy only: Presence of T1Gd + lesion on the screening MRI
- Any known or suspected active infection at screening or baseline, (excluding onychomycosis) or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks prior to and during screening or treatment with oral antimicrobials within 2 weeks prior to and during screening Onychomycosis is not exclusionary unless it is being treated with systemic therapy.
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- Patients with a previous history of a serious IRR and/or any hypersensitivity reaction to ocrelizumab
- History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- Immunocompromised state
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Switzerland
- India
- United Kingdom
- Canada
- Australia
- Turkey
- New Zealand
- Israel
- North Macedonia
- Ukraine
- Chile
- Colombia
- Mexico
- Brazil
- Russian Federation
- Argentina
- Peru
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Switzerland; India; United Kingdom; Canada; Australia and 13 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.