Natalizumab Subcutaneous Immunogenicity and Safety Study (SIMPLIFY)

Biogen

Status and phase: Terminated; Phase 2

Conditions: Relapsing Multiple Sclerosis

Treatments: Drug: natalizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02142192

101MS207

2014-000917-30 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

natalizumab

Experimental group

Description:

natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44)

Treatment:

Drug: natalizumab