Study Stopped
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Natalizumab Subcutaneous Immunogenicity and Safety Study
SIMPLIFY
A Multicenter, Open-Label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
2 other identifiers
interventional
2
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Dec 2014
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2014
CompletedFirst Posted
Study publicly available on registry
May 20, 2014
CompletedStudy Start
First participant enrolled
December 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 4, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2015
CompletedJune 3, 2024
May 1, 2024
6 months
May 16, 2014
May 31, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
Proportion of participants with transient anti-natalizumab antibodies
48 weeks
Proportion of participants with post-injection adverse events (AEs)
48 weeks
Proportion of participants with clinical relapse
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
Study Arms (1)
natalizumab
EXPERIMENTALnatalizumab 300mg SC every 4 weeks for up to 12 treatment administrations (i.e. Day 1 through Week 44)
Interventions
Administered as specified in the treatment arm
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Research Site
Leuven, 3000, Belgium
Research Site
Liège, 4000, Belgium
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2014
First Posted
May 20, 2014
Study Start
December 1, 2014
Primary Completion
June 4, 2015
Study Completion
June 4, 2015
Last Updated
June 3, 2024
Record last verified: 2024-05