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Recruiting Phase 2 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)

Phase 2 – studying effectiveness and dosage
Conditions: Progressive Multiple Sclerosis

Sponsor: Hoffmann-La Roche

trial.available_in: БГ
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.
Who can participate
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
Interventions
RO7268489
DRUG
Ocrelizumab
DRUG
Placebo
DRUG
Locations 47
Australia (1)
Southern Neurology
Kogarah , New South Wales
France (5)
Groupe Hospitalier Pellegrin
Bordeaux , Gironde
Hopital Gui de Chauliac
Montpellier , Herault
Groupe Hospitalier Pitie-Salpetriere
Paris
CHU Rennes - Hopital Pontchaillou
Rennes
Hopital Purpan
Toulouse , Haute Garonne
Italy (2)
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milan , Lombardy
Azienda Socio Sanitaria Territoriale Niguarda (Grande Ospedale Metropolitano Niguarda)
Milan , Lombardy
New Zealand (2)
Optimal Clinical Trials - Central
Auckland
Optimal Clinical Trials - Christchurch
Christchurch Central City , South Island
Poland (12)
Centrum Medyczne Pratia Katowice I
Katowice , Silesian Voivodeship
NEURO-CARE Sp. z o.o. Sp. Komandytowa
Katowice , Silesian Voivodeship
M.A. LEK A.M.Maciejowscy SC.
Katowice
Resmedica NZOZ Kielce
Kielce
Samodzielny Publiczny Zakad Opieki Zdrowotnej Szpital Uniwersytecki w Krakowie
Krakow
Szpital Specjalistyczny im. L. Rydygiera w Krakowie
Krakow
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin
Zanamed Medical Clinic sp z o o
Lublin
Centrum Medyczne Medyk
Rzeszów
Nmedis sp. z o.o.
Rzeszw , Podkarpackie Voivodeship
Centrum Medyczne NeuroProtect
Warsaw
Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa SzyszkoSUM w Katowicach
Zabrze
Spain (13)
Complejo Hospitalario Universitario de Albacete
Albacete
Hospital del Mar
Barcelona
Hospital Universitari Vall d Hebron
Barcelona
Hospital Clinic de Barcelona
Barcelona
Hospital Universitario de la Princesa
Madrid
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Clinico San Carlos
Madrid
Hospital Regional Universitario de Malaga
Málaga
Hospital Universitario Quironsalud Madrid
Pozuelo de Alarcón , Madrid
Hospital Santa Caterina
Salt , Girona
Hospital Universitario Virgen Macarena
Seville
Hospital Universitari i Politecnic La Fe
Valencia
Hospital Alvaro Cunqueiro
Vigo , Pontevedra
Turkey (7)
Hacettepe University of Medicine
Ankara
Gazi University Medical Faculty
Ankara
Ankara City Hospital
Ankara
Istanbul University Istanbul Medical Faculty
Istanbul
Istanbul University Cerrahpasa Medical Faculty
Istanbul
Sancaktepe Sehit Prof Dr Ilhan Varank Training and Research Hospital
Istanbul
Kocaeli University Medical Faculty
Kocaeli , Izmit
United Kingdom (5)
Queen Elizabeth University Hospital
Glasgow , Strathclyde
Charing Cross Hospital
London , Greater London
Salford Care Organisation
Salford
Morriston Hospital
Swansea
Royal Cornwall Hospital
Truro , Cornwall
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
10.03.2026
Completion date
30.05.2030
Registry ID
NCT07282574
Source
clinicaltrials.gov
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