Natalizumab Subcutaneous Immunogenicity and Safety Study

• Status: Terminated
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the immunogenicity of natalizumab (BG00002) 300 mg subcutaneous (SC) administered to participants with relapsing multiple sclerosis (RMS). The secondary objectives of the study are to evaluate the safety of natalizumab SC injections and to evaluate the efficacy of natalizumab SC injections on relapses and on new magnetic resonance imaging (MRI) lesions.

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

Details

• Lead Sponsor: Biogen
• Treatments: Natalizumab

Criteria

Key Inclusion Criteria:

• Must have documented diagnosis of RMS at screening.

• Must fall within the therapeutic indications stated in the locally approved label for natalizumab.

• Must have an EDSS score from 0 to 6.5, inclusive.

Key Exclusion Criteria:

• Any prior use of natalizumab.

• Positive for anti-natalizumab antibodies at screening.

• Treatment with immunomodulatory injections (including IFN-β and glatiramer acetate) within 2 weeks prior to Screening.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply