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 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 360
Last updated 2026-05-22
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.
Conditions
Interventions
- DRUG
-
RO7268489
RO7268489 will be administered per schedule as specified in the arms.
- DRUG
-
Ocrelizumab
Ocrelizumab will be administered per schedule as specified in the arms.
- DRUG
-
Placebo will be administered per schedule as specified in the arms.
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-10
- Primary Completion
- 2028-05-30
- Completion
- 2030-05-30
- FDA Drug
- Yes
Countries
- Australia
- France
- Germany
- Hungary
- Italy
- New Zealand
- Poland
- Portugal
- Spain
- Turkey (Türkiye)
- United Kingdom
Study Locations
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