NCT07282574

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)

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Progressive Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	RO7268489	RO7268489 will be administered per schedule as specified in the arms.
DRUG	Ocrelizumab	Ocrelizumab will be administered per schedule as specified in the arms.
DRUG	Placebo	Placebo will be administered per schedule as specified in the arms.

Timeline

• Start date: 2026-03-10
• Primary completion: 2028-05-30
• Completion: 2030-05-30
• First posted: 2025-12-15
• Last updated: 2026-03-30

Locations

30 sites across 6 countries: Australia, New Zealand, Poland, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study