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)
Recruiting · NCT07282574 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
60 locations listed.
- ProNeuro Centrum Medyczne - ?ory, Poland
- SOMED - Lodzkie Centrum Osteoporozy - ?ód?, Poland
- Complejo Hospitalario Universitario de Albacete - Albacete, Spain
- Hacettepe University of Medicine - Ankara, Turkey (Türkiye)
- Gazi University Medical Faculty - Ankara, Turkey (Türkiye)
- Ankara City Hospital - Ankara, Turkey (Türkiye)
- Optimal Clinical Trials - Central - Auckland, New Zealand
- Hospital del Mar - Barcelona, Spain
- Hospital Universitari Vall d Hebron - Barcelona, Spain
- Hospital Clinic de Barcelona - Barcelona, Spain
- Hospital de la Santa Creu i Sant Pau - Barcelona, Spain
- Charité Universitaetsmedizin Berlin - Campus Ch - Berlin, Germany
- Hospital de Braga - Braga, Portugal
- Hopital Neurologique Pierre Wertheimer - Bron, France
- Clinexpert Kft. - Budapest, Hungary
- S-Medicon Egeszsegugyi Szolgaltato Kft. - Budapest, Hungary
- Bajcsy-Zsilinszky Korhaz es Rendelointezet - Budapest, Hungary
- Budapesti Uzsoki Utcai Kórház - Budapest, Hungary
- Neurocentrum Bydgoszcz sp z o.o - Bydgoszcz, Poland
- University Hospital of Wales - Cardiff, United Kingdom
- ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra - Coimbra, Portugal
- Debreceni Egyetem Klinikai Kozpont Kenezy Gyula Campus - Debrecen, Hungary
- COPERNICUS Podmiot Leczniczy Sp z o o - Gda?sk, Poland
- Universitaetsklinikum Hamburg-Eppendorf - Hamburg, Germany
- 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)
- Ege University Medical Faculty - Izmir, Turkey (Türkiye)
- M.A. LEK A.M.Maciejowscy SC. - Katowice, Poland
- Resmedica NZOZ Kielce - Kielce, Poland
- Selcuk Universitesi Selcuklu Tip Fakultesi Hastanesi - Konya, Turkey (Türkiye)
- Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie - Krakow, Poland
- Szpital Specjalistyczny im. L. Rydygiera w Krakowie - Krakow, Poland
- ULS São José - Hospital de Sto António dos Capuchos;CRI Esclerose Múltipla - Lisbon, Portugal
- Hospital de Egas Moniz - Lisbon, Portugal
- Royal London Hospital - London, United Kingdom
- Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. - Lublin, Poland
- Zanamed Medical Clinic sp z o o - Lublin, Poland
- Hospital Universitario de la Princesa - Madrid, Spain
- Hospital General Universitario Gregorio Maranon - Madrid, Spain
- Hospital Universitario Ramon y Cajal - Madrid, Spain
- Hospital Clinico San Carlos - Madrid, Spain
- Hospital Regional Universitario de Malaga - Málaga, Spain
- Groupe Hospitalier Pitie-Salpetriere - Paris, France
- CHU Rennes - Hopital Pontchaillou - Rennes, France
- Centrum Medyczne Medyk - Rzeszów, Poland
- Salford Care Organisation - Salford, United Kingdom
- Centro Hospitalar Entre o Douro e Vouga E.P.E. - Hospital de São Sebastião - Santa Maria da Feira, Portugal
- Hospital Universitario Virgen Macarena - Seville, Spain
- Morriston Hospital - Swansea, United Kingdom
- Hospital Universitari i Politecnic La Fe - Valencia, Spain
- Centrum Medyczne NeuroProtect - Warsaw, Poland
- Penta Hospitals Przychodnie, Wroclaw Wejherowska - Wroc?aw, Poland
- Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach - Zabrze, Poland
- Fondazione Università G. D'Annunzio - Chieti, Abruzzo, Italy
- Universitaetsklinikum Freiburg - Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Universitaetsmedizin Mannheim - Mannheim, Baden-Wurttemberg, Germany
- Universitaetsklinikum Tuebingen - Tübingen, Baden-Wurttemberg, Germany
- Studienzentrum Neuropoint GmbH, - Ulm, Baden-Wurttemberg, Germany
- Universitaetsklinikum Ulm - Ulm, Baden-Wurttemberg, Germany
Showing 60 of 108 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →