A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)

Autoimmune Disorder
Multiple Sclerosis (MS)
Progressive Multiple Sclerosis (PMS)

For Medical Professional
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Basic Details

Sponsor Hoffmann-La Roche

Phase Phase 2

Trial Identifier NCT07282574, BP46016, 2025-521636-10-00

Condition Progressive Multiple Sclerosis

Official 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

Study Summary

The main purpose of this study is to assess the efficacy of RO7268489 in adults with progressive multiple sclerosis (PMS) receiving ocrelizumab. After the end of the double-blind period, an open-label (OL) extension may allow eligible participants to receive open-label RO7268489.

Eligibility Criteria

Gender

All

Age

≥18 Years & ≤ 60 Years

Healthy Volunteers

Inclusion Criteria

PMS, in accordance with the revised 2017 McDonald criteria
Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive

Exclusion Criteria

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

This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.

The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.

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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)

Basic Details

Study Summary

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

What is Clinical Research?

For the latest version of this information please go to www.forpatients.roche.com

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A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of RO7268489 as Add-on Therapy to Ocrelizumab, in Participants With Progressive Forms of Multiple Sclerosis (MS)

For the latest version of this information please go to www.forpatients.roche.com