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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)
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

RecruitingPhase 2

Sponsor: Hoffmann-La Roche

Conditions: Progressive Multiple Sclerosis

Interventions: RO7268489, Ocrelizumab, Placebo

Countries: Australia, France, Germany, Hungary, Italy, New Zealand, Poland, Portugal

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 overview

Sex: ALL

Age: 18 Years to 60 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (103)
  • Kogarah, New South Wales, Australia
  • New Lambton Heights, New South Wales, Australia
  • Box Hill, Victoria, Australia
  • Heidelberg, Victoria, Australia
  • Strasbourg, Bas Rhin, France
  • Nîmes, Gard, France
  • Bordeaux, Gironde, France
  • Toulouse, Haute Garonne, France
  • Montpellier, Herault, France
  • Saint-Herblain, Loire Atlantique, France
  • Nancy, Meurthe Et Moselle, France
  • Clermont-Ferrand, Puy De Dome, France
  • Bron, France
  • Paris, France
  • Rennes, France
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Tübingen, Baden-Wurttemberg, Germany
  • Ulm, Baden-Wurttemberg, Germany
  • Ulm, Baden-Wurttemberg, Germany
  • Erlangen, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Munich, Bavaria, Germany
  • Bochum, North Rhine-Westphalia, Germany
  • Düsseldorf, North Rhine-Westphalia, Germany
  • Dresden, Saxony, Germany
  • Leipzig, Saxony, Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Pécs, Baranya, Hungary
  • Budapest, Hungary
  • + 73 more on CT.gov