RecruitingPhase 2NCT07282574

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

Sponsor

Hoffmann-La Roche

Enrollment

360 participants

Start Date

Mar 10, 2026

Study Type

INTERVENTIONAL

Conditions

Progressive Multiple Sclerosis

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding a new drug called RO7268489 to ocrelizumab (a standard treatment) can slow the progression of progressive multiple sclerosis (MS) — the form of MS that gradually worsens over time. **You may be eligible if...** - You have been diagnosed with progressive MS (primary or secondary) according to established criteria - Your disability score (EDSS) is between 3.0 and 6.0 (meaning you have some mobility limitations but can still walk) **You may NOT be eligible if...** - You had an MS relapse in the 6 months before the study start date - You cannot have an MRI scan - You have poor venous access for IV infusions - You received IV immunoglobulin or plasmapheresis (a blood-filtering treatment) within the past 12 weeks - You have a history of drug or alcohol abuse within the past 5 years - You have contraindications to medications required alongside ocrelizumab Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRO7268489

RO7268489 will be administered per schedule as specified in the arms.

DRUGOcrelizumab

Ocrelizumab will be administered per schedule as specified in the arms.

DRUGPlacebo

Placebo will be administered per schedule as specified in the arms.

Locations(47)

Southern Neurology

Kogarah, New South Wales, Australia

Groupe Hospitalier Pellegrin

Bordeaux, Gironde, France

Hopital Purpan

Toulouse, Haute Garonne, France

Hopital Gui de Chauliac

Montpellier, Herault, France

Groupe Hospitalier Pitie-Salpetriere

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)

Milan, Lombardy, Italy

Optimal Clinical Trials - Christchurch

Christchurch Central City, South Island, New Zealand

Optimal Clinical Trials - Central

Auckland, New Zealand

Nmedis sp. z o.o.

Rzeszw, Podkarpackie Voivodeship, Poland

Centrum Medyczne Pratia Katowice I

Katowice, Silesian Voivodeship, Poland

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, Silesian Voivodeship, Poland

M.A. LEK A.M.Maciejowscy SC.

Katowice, Poland

Resmedica NZOZ Kielce

Kielce, Poland

Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie

Krakow, Poland

Szpital Specjalistyczny im. L. Rydygiera w Krakowie

Krakow, Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, Poland

Zanamed Medical Clinic sp z o o

Lublin, Poland

Centrum Medyczne Medyk

Rzeszów, Poland

Centrum Medyczne NeuroProtect

Warsaw, Poland

Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach

Zabrze, Poland

Hospital Santa Caterina

Salt, Girona, Spain

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Complejo Hospitalario Universitario de Albacete

Albacete, Spain

Hospital del Mar

Barcelona, Spain

Hospital Universitari Vall d Hebron

Barcelona, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

Hospital Universitario de la Princesa

Madrid, Spain

Hospital General Universitario Gregorio Maranon

Madrid, Spain

Hospital Clinico San Carlos

Madrid, Spain

Hospital Regional Universitario de Malaga

Málaga, Spain

Hospital Universitario Virgen Macarena

Seville, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Kocaeli University Medical Faculty

Kocaeli, Izmit, Turkey (Türkiye)

Hacettepe University of Medicine

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara City Hospital

Ankara, Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty

Istanbul, Turkey (Türkiye)

Istanbul University Cerrahpasa Medical Faculty

Istanbul, Turkey (Türkiye)

Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital

Istanbul, Turkey (Türkiye)

Royal Cornwall Hospital

Truro, Cornwall, United Kingdom

Charing Cross Hospital

London, Greater London, United Kingdom

Queen Elizabeth University Hospital

Glasgow, Strathclyde, United Kingdom

Salford Care Organisation

Salford, United Kingdom

Morriston Hospital

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07282574

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