MSFrontier

Mintaka

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
RecruitingPhase 2Progressive MSNCT072825742025-521636-10-00

What it found

Still running

No result yet.

What was tested

Treatment tested

  • RO7268489
  • Ocrelizumab

    B-lymphocyte antigen CD20 binding agent

Placebo or sham

  • Placebo
  • RO7268489 Placebo

What it measured

Main measures

  • Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12)

    Up to approximately 110 weeks

    Disability progressionWalking and mobility

  • 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)

    Disability progressionWalking and mobility

Other measures (20)

  • Time From Randomization to the First Occurrence of 24-Week Confirmed ≥4-Point Decrease (Worsening) in Symbol Digit Modalities Test (SDMT)

    Up to approximately 110 weeks

    Thinking and memory

  • Time to Onset of 24-Week cCDP (cCDP24)

    Up to approximately 110 weeks

  • Time to Onset of 12-Week Confirmed Disability Progression CDP (CDP12)

    Up to approximately 110 weeks

    Disability progression

  • Time to Onset of 24-Week CDP (CDP24)

    Up to approximately 110 weeks

    Disability progression

  • Time to ≥ 20% Increase in 12-week Confirmed Timed 25-Foot Walk Test (T25FWT)

    Up to approximately 110 weeks

    Disability progressionWalking and mobility

  • Time to ≥ 20% Increase in 24-week Confirmed T25FWT

    Up to approximately 110 weeks

    Disability progressionWalking and mobility

  • Time to ≥ 20% Increase in 12-week Confirmed 9-Hole Peg Test (9-HPT)

    Up to approximately 110 weeks

    Disability progression

  • Time to ≥ 20% Increase in 24-week Confirmed 9-HPT

    Up to approximately 110 weeks

  • Change From Baseline in Total Brain Volume

    Up to approximately 110 weeks

    Brain volume loss

  • Plasma 2-arachidonoylglycerol (2-AG) Levels

    Up to approximately 110 weeks

Who could take part

Progressive MS · 18 to 60

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 * Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit Exclusion Criteria: * MS relapse during the 6 months preceding the randomization date * Lack of peripheral venous access * History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening * Inability to complete a magnetic resonance imaging (MRI) * Contraindications to ocrelizumab mandatory pre-medications * Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

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Related trials

History

    1. Started

      Mar 2026

    2. Main results due

      May 2028

    3. Finished

      May 2030

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