A Study of Ocrelizumab in Participants With Primary Progressive Multiple Sclerosis

• Status: Active, not recruiting
• Trial end date: 2023-12-16
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, parallel group, double-blind, placebo controlled study will evaluate the efficacy and safety of ocrelizumab in participants with primary progressive multiple sclerosis. Eligible participants will be randomized 2 : 1 to receive either ocrelizumab or placebo. The blinded treatment period will be at least 120 weeks, followed by an Open Label Extension (OLE) treatment for participants in both groups who in the opinion of the investigator could benefit from further or newly initiated ocrelizumab treatment. Unless terminated early, all participants may continue their treatment with open-label ocrelizumab until 31 December 2020.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ocrelizumab

Criteria

Inclusion Criteria:

• Diagnosis of primary progressive multiple sclerosis (according to revised McDonald criteria)

• EDSS at screening from 3 to 6.5 points

• Disease duration from onset of MS symptoms less than (<) 15 years if EDSS greater than (>) 5.0; <10 years if EDSS greater than or equal to (>/=) 5.0

• Sexually active male and female participants of reproductive potential must use two methods of contraception throughout the study treatment phase and for 48 weeks after the last dose

Exclusion Criteria:

• History of relapsing remitting MS, secondary progressive, or progressive relapsing MS at screening

• Inability to complete an MRI (contraindications for MRI)

• Known presence of other neurologic disorders

• Known active infection or history of or presence of recurrent or chronic infection

• History of cancer, including solid tumors and hematological malignancies (except for basal cell, in situ squamous cell carcinomas of the skin and in situ carcinoma of the cervix that have been excised and resolved)

• Previous treatment with B-cell targeted therapies (e.g. rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)

• Any previous treatment with lymphocyte trafficking blockers, with alemtuzumab, anti-cluster of differentiation 4 (CD4), cladribine, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation

• Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study