A Phase III, multicenter, randomized, parallel-group, double blinded, placebo controlled study to evaluate the efficacy and safety of ocrelizumab in adults with Primary Progressive Multiple Sclerosis

Phase 3

Completed

• Conditions: PPMS; Primary Progressive Multiple Sclerosis; 10012303

• Registration Number: NL-OMON50554
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 2023-10-20
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

- Adult patients, Ages 18-55 years inclusive
- Primary Progressive Multiple Sclerosis (according to revised McDonald
criteria)
- Expanded Disability Status Scale (EDSS) 3.0 to 6.5 points
- Disease duration from the onset of MS symptoms:
a. less than 15 years in patients with an EDSS at screening > 5.0
b. less than 10 years in patients with an EDSS at screening <= 5.0
- Sexually active female and male patients of reproductive potential must use:
Female: two methods of contraception throughout the trial, including the
active treatment phase AND for 48 weeks after the last dose of ocrelizumab, or
until their B-cells have repleted, whichever is longer.
Male: two methods of contraception throughout trial, including the active
treatment phase AND for 24 weeks after the last dose of ocrelizumab.

Exclusion Criteria

- History of relapsing remitting multiple sclerosis, secondary progressive, or
progressive relapsing multiple sclerosis at screening
- Contraindications for Magnetic Resonance Imaging (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-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;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Efficacy: Time to onset of of confirmed disability progression, defined as an<br /><br>increase in Expanded Disability Status Scale (EDSS) score that is<br /><br>sustained for at least 12 weeks</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Time to confirmed disability progression, defined as an increase in EDSS<br /><br>score that is sustained for at least 24 weeks<br /><br>2. Change in timed 25-foot walk<br /><br>3. Change in total volume of T2 lesions on magnetic resonance imaging (MRI)<br /><br>scans of the brain<br /><br>4. Safety and tolerability: Incidence of adverse events</p><br>