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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
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.
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
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
360
Start Date
2026-03-10
Completion Date
2030-05-30
Last Updated
2026-03-30
Healthy Volunteers
No
Conditions
Interventions
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
Placebo
Placebo will be administered per schedule as specified in the arms.
Locations (30)
Southern Neurology
Kogarah, New South Wales, Australia
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
Centrum Medyczne Medyk
Rzeszów, Poland
Centrum Medyczne NeuroProtect
Warsaw, Poland
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, 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)
Queen Elizabeth University Hospital
Glasgow, Strathclyde, United Kingdom