Recruiting NCT07282574
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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7268489, Ocrelizumab, Placebo.
- Who it may be relevant to
- Registry conditions: Progressive Multiple Sclerosis. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Australia, France, Germany, Hungary, Italy +6
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug RO7268489
RO7268489 will be administered per schedule as specified in the arms. - Drug Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms. - Drug Placebo
Placebo will be administered per schedule as specified in the arms.
Primary outcome measures
- Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12) [Time frame: Up to approximately 110 weeks]
Secondary outcome measures (12)
- Time From Randomization to the First Occurrence of 24-Week Confirmed ≥4-Point Decrease (Worsening) in Symbol Digit Modalities Test (SDMT) [Time frame: Up to approximately 110 weeks]
- Change From Baseline in Total Brain Volume [Time frame: Up to approximately 110 weeks]
- Time to Onset of 24-Week cCDP (cCDP24) [Time frame: Up to approximately 110 weeks]
- Time to Onset of 12-Week Confirmed Disability Progression CDP (CDP12) [Time frame: Up to approximately 110 weeks]
- Time to Onset of 24-Week CDP (CDP24) [Time frame: Up to approximately 110 weeks]
- Time to ≥ 20% Increase in 12-week Confirmed Timed 25-Foot Walk Test (T25FWT) [Time frame: Up to approximately 110 weeks]
- Time to ≥ 20% Increase in 24-week Confirmed T25FWT [Time frame: Up to approximately 110 weeks]
- Time to ≥ 20% Increase in 12-week Confirmed 9-Hole Peg Test (9-HPT) [Time frame: Up to approximately 110 weeks]
- Time to ≥ 20% Increase in 24-week Confirmed 9-HPT [Time frame: Up to approximately 110 weeks]
- Plasma 2-arachidonoylglycerol (2-AG) Levels [Time frame: Up to approximately 110 weeks]
- Change From Baseline in Plasma 2-AG Levels [Time frame: Up to approximately 110 weeks]
- Number of Participants With Adverse events (AEs) [Time frame: Up to 5 years]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Spain · 20 centers
- Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
- Hospital Santa Caterina — Salt
- Complejo Hospitalario Universitario de Santiago. — Santiago de Compostela
- Hospital Universitari Arnau de Vilanova — Lleida
- Hospital Universitario Quironsalud Madrid — Pozuelo de Alarcón
- Hospital Universitario Virgen de La Arrixaca — El Palmar
- Hospital Alvaro Cunqueiro — Vigo
- Hospital de Cruces — Barakaldo
- … and 12 more centers
Poland · 17 centers
- Nmedis sp. z o.o. — Rzeszw
- Centrum Medyczne Pratia Katowice I — Katowice
- NEURO-CARE Sp. z o.o. Sp. Komandytowa — Katowice
- ProNeuro Centrum Medyczne — ?ory
- SOMED - Lodzkie Centrum Osteoporozy — ?ód?
- Neurocentrum Bydgoszcz sp z o.o — Bydgoszcz
- COPERNICUS Podmiot Leczniczy Sp z o o — Gda?sk
- M.A. LEK A.M.Maciejowscy SC. — Katowice
- … and 9 more centers
Germany · 13 centers
- Universitaetsklinikum Freiburg — Freiburg im Breisgau
- Universitaetsklinikum Tuebingen — Tübingen
- Studienzentrum Neuropoint GmbH, — Ulm
- Universitaetsklinikum Ulm — Ulm
- Universitaetsklinikum Erlangen — Erlangen
- LMU-Campus Grosshadern — Munich
- Klinikum rechts der Isar der TU Muenchen — Munich
- St. Josef-Hospital Universitaetsklinikum — Bochum
- … and 5 more centers
France · 11 centers
- CHU Strasbourg Hpital Hautepierre — Strasbourg
- Hopital Caremeau — Nîmes
- Groupe Hospitalier Pellegrin — Bordeaux
- Hopital Purpan — Toulouse
- Hopital Gui de Chauliac — Montpellier
- CHU Nantes - Hopital Nord Laënnec — Saint-Herblain
- CHU Nancy Hôpital Central — Nancy
- CHU Hopital Gabriel Montpied — Clermont-Ferrand
- … and 3 more centers
Italy · 10 centers
- Fondazione Università G. D'Annunzio — Chieti
- Azienda Ospedaliera Universitaria Federico II — Naples
- Azienda Ospedaliera Universitaria- Universit degli Studi della Campania Luigi Vanvitelli — Naples
- Az. Osp. OO.RR. S. Giovanni di Dio e Ruggi D' Aragona — Salerno
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata — Roma
- IRCCS AOM Azienda Ospedaliera Metropolitana — Genoa
- Ospedale San Raffaele — Milan
- Fondazione IRCCS Istituto Neurologico Carlo Besta — Milan
- … and 2 more centers
Turkey (Türkiye) · 8 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 7 centers
Center list to be confirmed — check the primary protocol.
Hungary · 6 centers
- Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs
- Clinexpert Kft. — Budapest
- S-Medicon Egeszsegugyi Szolgaltato Kft. — Budapest
- Bajcsy-Zsilinszky Korhaz es Rendelointezet — Budapest
- Budapesti Uzsoki Utcai Kórház — Budapest
- Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus — Debrecen
Portugal · 5 centers
- Hospital de Braga — Braga
- ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra — Coimbra
- ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla — Lisbon
- Hospital de Egas Moniz — Lisbon
- Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião — Santa Maria da Feira
Australia · 4 centers
- Southern Neurology — Kogarah
- John Hunter Hospital — New Lambton Heights
- Box Hill Hospital — Box Hill
- Austin Health — Heidelberg
New Zealand · 2 centers
- Optimal Clinical Trials - Christchurch — Christchurch Central City
- Optimal Clinical Trials - Central — Auckland
Identifiers
NCT: NCT07282574 · BP46016 · 2025-521636-10-00