Clinical Trial Results:
A safety open-label study of Gevokizumab in the treatment of patients with chronic non-infectious Uveitis disease, an eXtension study. The EYEGUARD-X study.
Summary
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EudraCT number |
2013-004973-29 |
Trial protocol |
DE GB IT PT ES AT GR |
Global end of trial date |
02 Nov 2015
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Results information
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Results version number |
v1(current) |
This version publication date |
18 Sep 2016
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First version publication date |
18 Sep 2016
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Other versions |
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 |
CL3-78989-019
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02375685 | ||
WHO universal trial number (UTN) |
U1111-1151-7937 | ||
Sponsors
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Sponsor organisation name |
Institut de Recherches Internationales Servier
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Sponsor organisation address |
50 rue Carnot, Suresnes, France,
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Public contact |
Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.com
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Scientific contact |
Clinical Studies Department, Institut de Recherches Internationales Servier, +33 155 72 43 66, clinicaltrials@servier.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 |
02 Nov 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
02 Nov 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
02 Nov 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 objective of this study is to evaluate long-term safety of gevokizumab in patient with chronic non-infectious uveitis who previously well tolerated the study drug and may benefit from longterm treatment with gevokizumab
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Protection of trial subjects |
This study was conducted in accordance with Good Clinical Practice standards, ethical principles stated in the Declaration of Helsinki and applicable regulatory requirements. After the subject has ended his/her participation in the trial, the investigator provided appropriate medication and/or arranged access to appropriate care for the patient.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
14 Aug 2014
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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 |
Portugal: 1
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Country: Number of subjects enrolled |
Spain: 10
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Country: Number of subjects enrolled |
Austria: 4
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Country: Number of subjects enrolled |
France: 3
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Country: Number of subjects enrolled |
Germany: 6
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Country: Number of subjects enrolled |
Greece: 3
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Country: Number of subjects enrolled |
Italy: 4
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Country: Number of subjects enrolled |
Australia: 3
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Country: Number of subjects enrolled |
Korea, Republic of: 18
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Country: Number of subjects enrolled |
Taiwan: 15
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Country: Number of subjects enrolled |
Tunisia: 2
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Country: Number of subjects enrolled |
Turkey: 8
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Worldwide total number of subjects |
77
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EEA total number of subjects |
31
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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) |
76
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||
Pre-assignment
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Screening details |
To be eligible, all subjects were to have chronic non-infectious uveitis disease, and to have completed the study CL3-78989-002 (EYEGUARD™-B), or X052130/CL3-78989-005 (EYEGUARD™-A) or X052131/CL3-78989-006 (EYEGUARD™-C), or were receiving a gevokizumab treatment as compassionate use. | ||||||||||||||
Pre-assignment period milestones
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Number of subjects started |
77 | ||||||||||||||
Number of subjects completed |
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Period 1
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Period 1 title |
treatment period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||
Arms
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Arm title
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Gevokizumab 60 mg | ||||||||||||||
Arm description |
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Arm type |
Experimental | ||||||||||||||
Investigational medicinal product name |
Gevokizumab
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Investigational medicinal product code |
S78989
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Subcutaneous use
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Dosage and administration details |
planned: one dose of gevokizumab 60 mg every 4 weeks from Week 0 up to Week 92
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Baseline characteristics reporting groups
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Reporting group title |
treatment period
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Reporting group description |
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End points reporting groups
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Reporting group title |
Gevokizumab 60 mg
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Reporting group description |
- | ||
Subject analysis set title |
safety set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All patients having taken at least one dose of IMP.
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End point title |
Number of patients with at least one adverse event [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Throughout the study
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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: Descriptive analysis was planned for this endpoint |
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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 |
All adverse events reported during the study (from W0 to the last visit) were taken into account.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
18.0
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Reporting groups
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Reporting group title |
Gevokizumab 60 mg
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Reporting group description |
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Frequency threshold for reporting non-serious adverse events: 2.5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? Yes | |||||||
Date |
Amendment |
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31 Jul 2014 |
- Update one of the inclusion criteria regarding the timelines between last study drug administration and inclusion in this study.
- Add instructions in case of indeterminate result of interferon-gamma release assay (IGRA).
- Update the study completion date, which depended on the end of CL3-78989-002 core study (event-driven trial). |
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27 Nov 2014 |
The requirement of the last IGRA re-test result before the first study drug administration for patients coming from compassionate use or for patients having received their last study drug administration more than 6 weeks before the inclusion visit. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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. | |||||||
None reported |