Efficacy and Safety of Ofatumumab Compared to Placebo in Patients With Relapsing Multiple Sclerosis Followed by Extended Treatment With Open-label Ofatumumab

• Status: Completed
• Trial end date: 2020-07-29
• Target enrollment: 0
• Participant gender: All

Summary

The study provided efficacy, safety, and pharmacokinetics (PK) data for patients with relapsing multiple sclerosis (RMS) in Japan and the other countries

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Antibodies, Monoclonal; Ofatumumab

Criteria

Inclusion Criteria:

• Diagnosis of multiple sclerosis (MS)

• Relapsing MS

• At least 1 appearance of a new neurological abnormality or worsening of pre-existing neurological abnormality during the previous 2 years prior to Screening AND an MRI activity (Gd-enhanced T1 lesions or new or enlarging T2 lesions) in brain during the previous 1 year prior to randomization

• EDSS score of 0 to 5.5

Exclusion Criteria:

• Primary progressive MS or SPMS without disease activity

• Patients with an active chronic disease of the immune system other than MS

• Patients at risk of developing or having reactivation of hepatitis

• Patients with active systemic infections or with neurological findings consistent with PML Other protocol-defined inclusion/exclusion criteria may apply