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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)
EU CTIS ID: 2023-506515-18-00
What this study is testing
To demonstrate the superiority of a higher dose of ocrelizumab over the approved dose of ocrelizumab as assessed by risk reduction in composite confirmed disability progression (cCDP) sustained for at least 12 weeks.
- 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
- 1. Ages 18-55 years at time of screening
- 2. Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017
- 3. Expanded disability status scale (EDSS) score at screening and baseline 3- 6.5, inclusive
- 4. Score of ≥ 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline
- 5. Documented MRI of brain with abnormalities consistent with MS
- 6. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments
You likely can't join if
- 1. History of relapsing remitting or secondary progressive MS at screening
- 2. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening
- 3. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
- 4. Immunocompromised state
- 5. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
- 6. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
The study team makes the final eligibility decision.
Where it's taking place
- Ukraine
- Argentina
- Brazil
- Mexico
- Russian Federation
- Switzerland
- Serbia
- Turkey
- United States
- Peru
- Canada
- 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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ukraine; Argentina; Brazil; Mexico; Russian Federation; Switzerland and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.