BP46016 RO7268489 AND OCRELIZUMAB IN PARTICIPANTS WITH PROGRESSIVE FORMS OF MS (MINTAKA)
Research type
Research Study
Full title
A MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE II STUDY EVALUATING THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND EFFICACY OF RO7268489, A MONOACYLGLYCEROL LIPASE INHIBITOR, AS ADD-ON THERAPY TO OCRELIZUMAB, IN PARTICIPANTS WITH PROGRESSIVE FORMS OF MULTIPLE SCLEROSIS
IRAS ID
1012889
Contact name
N/A N/A
Contact email
Sponsor organisation
F. Hoffmann-La Roche AG
Eudract number
2025-521636-10
Research summary
Aim of the study
The purpose of this study is to compare the effects of the study drug RO7268489 compared with placebo in people with multiple sclerosis that has progressed. In this study, this study drug will be tested at three different doses.
RO7268489 is a highly selective and reversible monoacylglycerol lipase (MAGL) inhibitor. Its novel mode of action may address the key unmet need in people with progressive forms of multiple sclerosis (MS): progression of disability. RO7268489 is being developed as an oral add-on treatment to ocrelizumab for Multiple Sclerosis (MS). RO7268489 is intended to target disease progression, may potentially improve neurological disability, cognitive dysfunction, and additionally may lead to the modulation of pain and spasticity, two of the most common symptoms of MS, as well as improving cognitive dysfunction associated with MS
Global number of patients, treatment arms & study:
Around 360 people with multiple sclerosis will take part in this study.Who would be eligible?
Participants with progressive forms of multiple sclerosis who are at risk of further disability progression will be eligible.
The study will last up to 5 years after the last participant is enrolled.
There will be approximately 25 patients recruited in the UK.
The study is sponsored by F. Hoffmann- La Roche
Research Summary; Version Number 1 and dated 28th July 2025;REC name
South Central - Hampshire B Research Ethics Committee
REC reference
25/SC/0342
Date of REC Opinion
23 Dec 2025
REC opinion
Further Information Favourable Opinion