A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

Phase 1

Recruiting

• Conditions: Primary progressive multiple sclerosis (PPMS); MedDRA version: 21.1Level: PTClassification code: 10063401Term: Primary progressive multiple sclerosis Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-505980-36-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-12
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Diagnosis of PPMS in accordance with the McDonald criteria (Thompson et al. 2017), 2. EDSS score at screening and baseline = 3.0 to 8.0, inclusive, 3. Disease duration from the onset of multiple sclerosis (MS) symptoms relative to randomization date: o Less than 20 years in patients with an EDSS score at screening 7.0-8.0 o Less than 15 years in patients with an EDSS at screening 5.5-6.5 o Less than 10 years in patients with an EDSS at screening = 5.0, 4. Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen o Elevated IgG index o One or more IgG oligoclonal bands detected by isoelectric focusing, 5. Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands), 6. Neurological stability for = 30 days prior to baseline

Exclusion Criteria

1. History of relapsing-remitting or secondary progressive MS at screening, 2. Confirmed serious opportunistic infection, 3. Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy, 4. Known active malignancy or are being actively monitored for recurrence of malignancy, 5. Immunocompromised state defined as one or more of the following: CD4 count < 250/µL, absolute neutrophil count <1.5 x 103/µL, Serum IgG < 4.6 g/L, 6. Receipt of a live-attenuated vaccine within 6 weeks prior to randomization

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified