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: Recruiting
Location: See all (30) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• PMS, in accordance with the revised 2017 McDonald criteria
• Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive
Locations
Other Locations
Australia
Southern Neurology
RECRUITING
Kogarah
New Zealand
Optimal Clinical Trials - Central
RECRUITING
Auckland
Optimal Clinical Trials - Christchurch
RECRUITING
Christchurch Central City
Poland
Centrum Medyczne Pratia Katowice I
RECRUITING
Katowice
M.A. LEK A.M.Maciejowscy SC.
RECRUITING
Katowice
NEURO-CARE Sp. z o.o. Sp. Komandytowa
RECRUITING
Katowice
Resmedica NZOZ Kielce
RECRUITING
Kielce
Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
RECRUITING
Krakow
Centrum Medyczne Medyk
RECRUITING
Rzeszów
Nmedis sp. z o.o.
RECRUITING
Rzeszw
Centrum Medyczne NeuroProtect
RECRUITING
Warsaw
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital Universitari Vall d Hebron
RECRUITING
Barcelona
Hospital Clinico San Carlos
RECRUITING
Madrid
Hospital General Universitario Gregorio Maranon
RECRUITING
Madrid
Hospital Universitario de la Princesa
RECRUITING
Madrid
Hospital Regional Universitario de Malaga
RECRUITING
Málaga
Hospital Universitario Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Hospital Alvaro Cunqueiro
RECRUITING
Vigo
Turkey
Ankara City Hospital
RECRUITING
Ankara
Gazi University Medical Faculty
RECRUITING
Ankara
Hacettepe University of Medicine
RECRUITING
Ankara
Istanbul University Cerrahpasa Medical Faculty
RECRUITING
Istanbul
Istanbul University Istanbul Medical Faculty
RECRUITING
Istanbul
Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
RECRUITING
Istanbul
Kocaeli University Medical Faculty
RECRUITING
Kocaeli
United Kingdom
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Contact Information
Primary
Reference Study ID Number: BP46016 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. Only)
Time Frame
Start Date: 2026-03-10
Estimated Completion Date: 2030-05-30
Participants
Target number of participants: 360
Treatments
Experimental: RO7268489 Dose 1 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Experimental: RO7268489 Dose 2 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Experimental: RO7268489 Dose 3 + Ocrelizumab
Participants will receive RO7268489 along with ocrelizumab as per the pre-defined regimen.
Placebo_comparator: Placebo + Ocrelizumab
Participants will receive RO7268489 matching placebo along with ocrelizumab as per the pre-defined regimen.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche