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NCT07282574 | RECRUITING | Progressive Multiple Sclerosis

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)
Sponsor:

Hoffmann-La Roche

Brief 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.

Condition or disease

Progressive Multiple Sclerosis

Intervention/treatment

RO7268489

Ocrelizumab

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 360 participants
Masking : QUADRUPLE
Primary Purpose : TREATMENT
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
Actual Study Start Date : 2026-02-28
Estimated Primary Completion Date : 2028-05-30
Estimated Study Completion Date : 2030-05-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
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)

Location Details

NCT07282574

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Turkey (Türkiye),

Hacettepe University of Medicine

Ankara, Turkey (Türkiye), 06100

RECRUITING

Turkey (Türkiye),

Gazi University Medical Faculty

Ankara, Turkey (Türkiye), 06500