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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
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-521636-10-00
Enrollment
220
Registered
2026-01-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progressive Forms of Multiple Sclerosis (PMS)

Brief summary

Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)

Detailed description

Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT), Plasma 2-arachidonoylglycreol (2-AG) levels, Change from baseline in plasma 2-AG levels, Incidence, severity, and causal relationship of adverse events (AEs), Incidence of treatment discontinuations due to AEs, Changes in vital signs and ECG parameters, Incidence of abnormal laboratory findings, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS), Plasma concentrations of RO7268489 and its metabolite(s) as appropriate

Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion
DRUGRO7268489 Placebo

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Time from randomization to the first occurrence of composite confirmed disability progression confirmed for at least 12 weeks (cCDP12) according to at least one of the following three criteria: o 12-week confirmed disability progression (CDP12) o 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or o 12-week confirmed increase in 9-Hole Peg Test (9-HPT)

Secondary

MeasureTime frame
Time from randomization to the first occurrence of 24-week confirmed ≥ 4-point decrease (worsening) in Symbol Digit Modalities Test (SDMT), Plasma 2-arachidonoylglycreol (2-AG) levels, Change from baseline in plasma 2-AG levels, Incidence, severity, and causal relationship of adverse events (AEs), Incidence of treatment discontinuations due to AEs, Changes in vital signs and ECG parameters, Incidence of abnormal laboratory findings, Proportion of participants with suicidal ideation or behavior, as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS), Plasma concentrations of RO7268489 and its metabolite(s) as appropriate

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026