Natalizumab Subcutaneous Immunogenicity and Safety Study

Study Overview
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Brief Summary
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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.

Official Title
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A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis

Conditions
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Relapsing Multiple Sclerosis

Intervention / Treatment
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* Drug: natalizumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: natalizumab<br>natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44) | Drug: natalizumab<br>* Administered as specified in the treatment arm<br>* Other names: Tysabri;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with persistent anti-natalizumab antibodies | Persistent anti-natalizumab antibodies are defined as 2 positive anti-natalizumab test results separated by at least 6 weeks, with at least 1 positive test result occurring at or after the Week 24 Visit. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of participants with transient anti-natalizumab antibodies |  | 48 weeks | 
| Proportion of participants with post-injection adverse events (AEs) | Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing. | 48 weeks | 
| Proportion of participants with clinical relapse | This may include new or enlarging T2 lesion(s), as determined by magnetic resonance imaging (MRI). Clinical relapse is defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the neurologist. | 48 weeks | 
| Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI. |  | 48 weeks | 
| Proportion of Participants that experience Adverse Events and Serious Adverse Events |  | up to 56 weeks |