A 12 Week Randomized Open Label Parallel Group Multicenter Study to Evaluate Bioequivalence of 20 mg Subcutaneous Ofatumumab Injected by Pre-filled Syringe or Autoinjector in Adult RMS Patients

• Status: Not yet recruiting
• Trial end date: 2019-08-02
• Target enrollment: 284
• Participant gender: All

Summary

The primary purpose of this study is to demonstrate pharmacokinetic bioequivalence of ofatumumab injected by Pre-filled Syringe (PFS) versus Auto-Injector (AI) devices and thereby establish a bridge between the ongoing Phase 3 program and the to-be-marketed drug-device combinations

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Ofatumumab

Criteria

Inclusion Criteria:

• Diagnosis of multiple sclerosis (MS)

• Relapsing MS: relapsing-remitting course (RRMS), or Secondary progressive (SPMS) course

• EDSS score of 0 to 5.5

• Documentation of at least: 1 relapse during the previous year OR 2 relapses during the previous 2 years prior to Screening OR a positive Gd-enhancing MRI scan during the year prior to randomization.

• Neurologically stable within 1 month prior to randomization

Exclusion Criteria:

• Patients with primary progressive MS or SPMS without disease activity

• Disease duration of more than 10 years in patients with EDSS score of 2 or less

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

• Patients with active systemic bacterial, viral or fungal infections, or known to have AIDS or to test positive for HIV antibody at Screening

• Patients with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML), or confirmed PML Other protocol-defined inclusion/exclusion criteria may apply