A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults with Relapsing Multiple Sclerosis

Phase 1

• Conditions: Relapsing Multiple Sclerosis (MS); MedDRA version: 20.1Level: PTClassification code: 10028245Term: Multiple sclerosis Class: 100000004852; MedDRA version: 21.1Level: PTClassification code: 10063399Term: Relapsing-remitting multiple sclerosis Class: 100000004852; MedDRA version: 20.1Level: LLTClassification code: 10039720Term: Sclerosis multiple Class: 10029205; MedDRA version: 20.0Level: PTClassification code: 10048393Term: Multiple sclerosis relapse Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: CTIS2023-506467-34-00
• Lead Sponsor: F. Hoffmann-La Roche AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

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

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 864

Inclusion Criteria

1. Ages 18-55 years at time of screening, 2. Diagnosis of RMS (i.e., RRMS or aSPMS where patients still experience relapses) in accordance with the revised McDonald Criteria 2017, 3. At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening (with no relapse 30 days prior to screening and at baseline), 4. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments, 5. Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive, 6. Documented MRI of brain with abnormalities consistent with MS

Exclusion Criteria

1. History of primary 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 confirmed or suspected progressive multifocal leukoencephalopathy (PML), 4. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening, 5. Immunocompromised state, 6. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study

Study & Design

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