A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (PPMS)

Phase 1

• Conditions: Primary Progressive Multiple Sclerosis (PPMS); MedDRA version: 20.1Level: LLTClassification code: 10039720Term: Sclerosis multiple Class: 10029205; MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852; MedDRA version: 21.1Level: PTClassification code: 10063401Term: Primary progressive multiple sclerosis Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-506515-18-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-18
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 769

Inclusion Criteria

1. Ages 18-55 years at time of screening, 2. Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017, 3. Expanded disability status scale (EDSS) score at screening and baseline 3- 6.5, inclusive, 4. Score of = 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline, 5. Documented MRI of brain with abnormalities consistent with MS, 6. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion Criteria

1. History of relapsing remitting or secondary progressive MS at screening, 2. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening, 3. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening, 4. Immunocompromised state, 5. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study, 6. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)

Study & Design

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