Health Trials

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)

ConditionProgressive Multiple Sclerosis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorHoffmann-La Roche

About this trial

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 criteria

Qualifiers

PMS, in accordance with the revised 2017 McDonald criteria

Expanded disability status scale (EDSS) at screening between 3.0 and 6.0 inclusive

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • RO7268489
  • Ocrelizumab
  • Placebo

Treatment groups

360 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov