MINTAKA · BP46016
A study exploring the safety, pharmacokinetics, pharmacodynamics, and efficacy of RO7268489, a monoacylglycerol lipase inhibitor, administered in combination with ocrelizumab for progressive forms of multiple sclerosis.
A multicenter, 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.
Sponsor: ROCHE
Phase: II
Status: Recruiting
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Public study eligibility criteria
Inclusion
- Age 18 to 60 years, inclusive, at the time of signing the Informed Consent Form
- Progressive multiple sclerosis, in accordance with the revised 2017 McDonald criteria (Thompson 2018)
- Expanded Disability Status Scale (EDSS) at Screening between 3.0 and 6.0 inclusive
- Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit, according to criteria provided in the protocol
- For patients who received ocrelizumab in the past and stopped it more than 2 years prior to screening, the reason for stopping or interrupting ocrelizumab must have been unrelated to safety / lack of efficacy and such patients must have normal B cell count at screening
- Agreement to wear digital gait assessment device as per study protocol
Exclusion
- MS relapse during the 6 months preceding the randomization date
- Lack of peripheral venous access
- History of alcohol or other drug abuse, in the opinion of the investigator, within 5 years prior to screening
- Inability to complete an magnetic resonance imaging (MRI)
- Contraindications to ocrelizumab mandatory pre-medications
- Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening