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SIMPLIFY: Natalizumab Subcutaneous Immunogenicity and Safety Study

Sponsor
Biogen (Industry)
Overall Status
Terminated
CT.gov ID
NCT02142192
Collaborator
(none)
2
Enrollment
2
Locations
1
Arm
23
Duration (Months)
1
Patient Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
2 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
Study Start Date :
Dec 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2016
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Experimental: natalizumab

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

Drug: natalizumab
Administered as specified in the treatment arm
Other Names:
  • BG00002
  • Tysabri

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of participants with persistent anti-natalizumab antibodies [48 weeks]

      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.

    Secondary Outcome Measures

    1. Proportion of participants with transient anti-natalizumab antibodies [48 weeks]

    2. Proportion of participants with post-injection adverse events (AEs) [48 weeks]

      Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.

    3. Proportion of participants with clinical relapse [48 weeks]

      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.

    4. Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI. [48 weeks]

    5. Proportion of Participants that experience Adverse Events and Serious Adverse Events [up to 56 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Research Site Leuven Belgium 3000
    2 Research Site Liege Belgium 4000

    Sponsors and Collaborators

    • Biogen

    Investigators

    • Study Director: Medical Director, Biogen

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Biogen
    ClinicalTrials.gov Identifier:
    NCT02142192
    Other Study ID Numbers:
    • 101MS207
    • 2014-000917-30
    First Posted:
    May 20, 2014
    Last Update Posted:
    Sep 29, 2016
    Last Verified:
    Sep 1, 2016
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Natalizumab

    Study Results

    No Results Posted as of Sep 29, 2016