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Natalizumab Subcutaneous Immunogenicity and Safety Study (SIMPLIFY)

Primary Purpose

Relapsing Multiple Sclerosis

Status
Terminated
Phase
Phase 2
Locations
Belgium
Study Type
Interventional
Intervention
natalizumab
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Relapsing Multiple Sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Research Site
  • Research Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

natalizumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Proportion of participants with transient anti-natalizumab antibodies
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.
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.
Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
Proportion of Participants that experience Adverse Events and Serious Adverse Events

Full Information

First Posted
May 16, 2014
Last Updated
September 27, 2016
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT02142192
Brief Title
Natalizumab Subcutaneous Immunogenicity and Safety Study
Acronym
SIMPLIFY
Official Title
A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision.
Study Start Date
December 2014 (undefined)
Primary Completion Date
November 2016 (Anticipated)
Study Completion Date
November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
natalizumab
Arm Type
Experimental
Arm Description
natalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44)
Intervention Type
Drug
Intervention Name(s)
natalizumab
Other Intervention Name(s)
BG00002, Tysabri
Intervention Description
Administered as specified in the treatment arm
Primary Outcome Measure Information:
Title
Proportion of participants with persistent anti-natalizumab antibodies
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Proportion of participants with transient anti-natalizumab antibodies
Time Frame
48 weeks
Title
Proportion of participants with post-injection adverse events (AEs)
Description
Including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.
Time Frame
48 weeks
Title
Proportion of participants with clinical relapse
Description
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.
Time Frame
48 weeks
Title
Proportion of participants with gadolinium (Gd) enhancing lesion(s) as assessed by MRI.
Time Frame
48 weeks
Title
Proportion of Participants that experience Adverse Events and Serious Adverse Events
Time Frame
up to 56 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium

12. IPD Sharing Statement

Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2014-000917-30/results
Description
EudraCT Tabulated Result

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Natalizumab Subcutaneous Immunogenicity and Safety Study

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