Clinical Trial Results:
A Multicenter, Open-label Immunogenicity and Safety Study of Subcutaneous Natalizumab 300 mg Administered to Subjects With Relapsing Multiple Sclerosis
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Summary
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EudraCT number |
2014-000917-30 |
Trial protocol |
DE IT DK BE |
Global end of trial date |
04 Jun 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
14 May 2016
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First version publication date |
14 May 2016
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
101MS207
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02142192 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Biogen
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Sponsor organisation address |
225 Binney Street, Cambridge, Massachusetts , United States, 02142
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Public contact |
Biogen Study Medical Director, Biogen , clinicaltrials@biogen.com
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Scientific contact |
Biogen Study Medical Director, Biogen , clinicaltrials@biogen.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Jun 2015
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Jun 2015
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to evaluate the immunogenicity of natalizumab 300 mg subcutaneous (SC) administered to subjects with relapsing multiple sclerosis (RMS). The secondary objectives 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.
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Protection of trial subjects |
Written informed consent was obtained from each subject prior to evaluations being performed for eligibility. Subjects were given adequate time to review the information in the informed consent and were allowed to ask, and have answered, questions concerning all portions of the conduct of the study. Through the informed consent process each subject was made aware of the purpose of the study, the procedures, the benefits and risks of the study, the discomforts and the precautions taken. Any side effects or other health issues occurring during the study were followed up by the study doctor. Subjects were able to stop taking part in the study at any time without giving any reason.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
26 Jan 2015
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Belgium: 2
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Worldwide total number of subjects |
2
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EEA total number of subjects |
2
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
2
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||
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Pre-assignment
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Screening details |
Subject eligibility for the study was determined within approximately 6 weeks prior to study entry. The screening period was extended if there were unforeseen delays in receiving laboratory results necessary for assessing eligibility. | ||||||||||
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Period 1
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Period 1 title |
Natalizumab (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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Natalizumab | ||||||||||
Arm description |
Natalizumab 300 mg SC every 4 weeks for up to 44 weeks | ||||||||||
Arm type |
Experimental | ||||||||||
Investigational medicinal product name |
natalizumab
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Investigational medicinal product code |
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Other name |
Tysabri
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
Subjects were to be treated with open-label natalizumab (300 mg SC) at Day 1 and Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
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Baseline characteristics reporting groups
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Reporting group title |
Natalizumab
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Reporting group description |
Natalizumab 300 mg SC every 4 weeks for up to 44 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Natalizumab
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Reporting group description |
Natalizumab 300 mg SC every 4 weeks for up to 44 weeks | ||
Subject analysis set title |
Safety population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
The safety population was defined as all subjects who received at least 1 dose of study treatment and had at least 1 post-baseline assessment of the parameter being analyzed.
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End point title |
Number of Subjects With Persistent Anti-natalizumab Antibodies Over 48 Weeks [1] | ||||||||
End point 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. Due to early termination, assessments were completed at screening, post-baseline Week 12, and at Safety Follow-up (12 weeks after last dose administered).
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End point type |
Primary
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End point timeframe |
Screening, Post-Baseline Week 12, Safety Follow-up (12 weeks after last dose administered [up to 172 days])
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analyses of the data were performed, since only 2 subjects were enrolled prior to study termination. Data were listed only. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects with Post-injection Adverse Events (AEs) | ||||||||
End point description |
The number of subjects with post-injection AEs including hypersensitivity reactions, anaphylactic reactions and other AEs occurring within 1 hour after SC natalizumab dosing.
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End point type |
Secondary
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End point timeframe |
Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Clinical Relapse or With New or Enlarging T2 Lesions | ||||||||
End point description |
The number of subjects with clinical relapse, or with new or enlarging T2 lesion(s), as determined by a central MRI reading center, over 48 weeks. Clinical relapse is defined as new or recurrent neurologic symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurologic findings upon examination by the Neurologist. The subject must have had objective signs on the neurologist’s examination that confirm the event.
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End point type |
Secondary
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End point timeframe |
Up to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Gadolinium (Gd)-enhancing Lesions | ||||||||
End point description |
Brain MRI scans were planned to occur during screening and then again at the Week 48 Visit and were to include T2 as well as T1 sequences with and without gadolinium (Gd). The data from all of the scheduled MRI scans were evaluated at a central MRI reading center to determine the level of disease activity. Due to early termination of the study, scans were performed at screening only.
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End point type |
Secondary
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End point timeframe |
Screening
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With AEs and Serious AEs (SAEs) | ||||||||
End point description |
An AE is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose (i) results in death, (ii) places the subject at immediate risk of death, (iii) requires inpatient hospitalization or prolongation of existing hospitalization, (iv) results in persistent or significant disability/incapacity or (v) results in a congenital anomaly/birth defect.
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End point type |
Secondary
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End point timeframe |
AEs: Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days]); SAEs: Informed Consent to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
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| No statistical analyses for this end point | |||||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs: Day 1 to Safety Follow-up (12 weeks after last dose administered [up to 172 days]); SAEs: Informed Consent to Safety Follow-up (12 weeks after last dose administered [up to 172 days])
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Assessment type |
Systematic | ||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||
Dictionary version |
17
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Reporting groups
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Reporting group title |
Safety Population
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Reporting group description |
All subjects who received at least 1 dose of study treatment and had at least 1 post-baseline assessment. | ||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| This study was terminated early by Biogen. This decision was independent of any safety, efficacy, or regulatory concerns related to natalizumab. | |||
