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Clinical Trials in Italy / NCT07282574
Recruiting Phase 2

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)

NCT07282574 · tracked via the Priya Life Science Italy tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2
Started
2026-03-10
Last updated
2026-10-07

Condition(s) studied

Progressive Multiple Sclerosis

Investigational drug(s) / intervention(s)

RO7268489Ocrelizumab →Placebo

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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 * Documented evidence of disability progression independent of relapse activity over the 2 years before the screening visit Exclusion Criteria: * MS relapse during the 6 months preceding the randomization date * Lack of peripheral venous access * History of alcohol or other drug abuse (substance use disorder) based on Diagnostic and Statistical Manual for Mental Disorders, fifth edition (DSM-5) criteria, within 5 years prior to screening * Inability to complete a magnetic resonance imaging (MRI) * Contraindications to ocrelizumab mandatory pre-medications * Treatment with intravenous immunoglobulin (IV Ig) or plasmapheresis within 12 weeks prior to screening

Primary outcome measure(s)

  • Time From Randomization to the First Occurrence of Composite Confirmed Disability Progression (cCPD) Confirmed for at Least 12 Weeks (cCDP12) — Up to approximately 110 weeks
    Time from randomization to the first occurrence of cCDP12 according to at least one of the following 3 criteria: 1. 12-week confirmed disability progression (CDP12) 2. 12-week confirmed increase in Timed 25-Foot Walk Test (T25FWT) or 3. 12-week confirmed increase in 9-Hole Peg Test (9-HPT) The EDSS is a disability scale is based on a standard neurological examination that ranges in 0.5-point steps from 0 (normal) - 10 (death). T25FWT=time taken to walk 25 feet, typically measured in seconds. The longer it takes to walk, the higher score, which indicates deterioration. Lower times indicate better performance and greater mobility. In 9-HPT, participants are instructed to place pegs one by one into each of nine holes arranged in a board stabilized with a plastic nonslip sheet on a solid table, and then to remove these pegs from the holes. The shorter time it takes to complete the task indicates a better outcome.

Trial sites (114)

FacilityCityRegionStatus
Brain and Mind Centre Camperdown New South Wales Recruiting
Southern Neurology Kogarah New South Wales Recruiting
John Hunter Hospital New Lambton Heights New South Wales Recruiting
Box Hill Hospital Box Hill Victoria Recruiting
Austin Health Heidelberg Victoria Recruiting
Centro de Pesquisas Clinicas - CPCLIN São Paulo São Paulo Recruiting
CHU Strasbourg Hpital Hautepierre Strasbourg Bas Rhin Recruiting
Hopital Caremeau Nîmes Gard Recruiting
Groupe Hospitalier Pellegrin Bordeaux Gironde Recruiting
Hopital Purpan Toulouse Haute Garonne Recruiting
Hopital Gui de Chauliac Montpellier Herault Recruiting
CHU Nantes - Hopital Nord Laënnec Saint-Herblain Loire Atlantique Recruiting
CHU Nancy Hôpital Central Nancy Meurthe Et Moselle Recruiting
CHU Hopital Gabriel Montpied Clermont-Ferrand Puy De Dome Recruiting
Hopital Neurologique Pierre Wertheimer Bron France Recruiting
Groupe Hospitalier Pitie-Salpetriere Paris France Recruiting
CHU Rennes - Hopital Pontchaillou Rennes France Recruiting
Universitaetsklinikum Freiburg Freiburg im Breisgau Baden-Wurttemberg Recruiting
Universitaetsmedizin Mannheim Mannheim Baden-Wurttemberg Recruiting
Universitaetsklinikum Tuebingen Tübingen Baden-Wurttemberg Recruiting
Studienzentrum Neuropoint GmbH, Ulm Baden-Wurttemberg Recruiting
Universitaetsklinikum Ulm Ulm Baden-Wurttemberg Recruiting
Universitaetsklinikum Erlangen Erlangen Bavaria Recruiting
LMU-Campus Grosshadern Munich Bavaria Recruiting
Klinikum rechts der Isar der TU Muenchen Munich Bavaria Recruiting
Universitaetsklinikum Frankfurt Goethe-Universitaet Frankfurt am Main Hesse Recruiting
St. Josef-Hospital Universitaetsklinikum Bochum North Rhine-Westphalia Recruiting
Universitaetsklinikum Bonn AoeR Bonn North Rhine-Westphalia Recruiting
Universitaetsklinikum Duesseldorf Düsseldorf North Rhine-Westphalia Recruiting
Universitaetsklinkm Essen Essen North Rhine-Westphalia Recruiting
Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden Saxony Recruiting
Universitaetsklinikum Leipzig Leipzig Saxony Recruiting
Charité Universitaetsmedizin Berlin - Campus Ch Berlin Germany Recruiting
Universitaetsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont Pécs Baranya Recruiting
Clinexpert Kft. Budapest Hungary Recruiting
S-Medicon Egeszsegugyi Szolgaltato Kft. Budapest Hungary Recruiting
Semmelweis Egyetem Budapest Hungary Recruiting
Bajcsy-Zsilinszky Korhaz es Rendelointezet Budapest Hungary Recruiting
Budapesti Uzsoki Utcai Kórház Budapest Hungary Recruiting

+ 74 more sites — see the full list on the official registry below.

On this site

📄 Ocrevus (ocrelizumab) drug profile →

More Hoffmann-La Roche trials in Italy

A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis Active, not recruiting
A Study Evaluating Different Immunotherapies (LAG-3 and PD-1 With or Without TIGIT, Compared to PD-L1 Alone) in Participants With Untreated Locally Advanced Metastatic Urothelial Cancer Active, not recruiting
A Study of 36-Week Refill Exchanges of Port Delivery System (PDS) With Ranibizumab in nAMD Recruiting
A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis Active, not recruiting
A Study Comparing Adjuvant Alectinib Versus Adjuvant Platinum-Based Chemotherapy in Patients With ALK Positive Non-Small Cell Lung Cancer Active, not recruiting

Other trials for the same condition

Effects of Transcranial Static Magnetic Field Stimulation (tSMS) in Progressive Multiple Sclerosis Recruiting
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07282574 on ClinicalTrials.gov ↗ ← All trials in Italy