Clinical Trial Results:
A Phase II Open-Label Extension Study to Evaluate the Long-Term Safety of Etrolizumab in Patients with Moderate to Severe Ulcerative Colitis
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Summary
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EudraCT number |
2011-003409-36 |
Trial protocol |
BE DE CZ ES GB |
Global end of trial date |
08 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
10 Aug 2017
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First version publication date |
10 Aug 2017
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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 |
GA27927
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Additional study identifiers
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ISRCTN number |
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US NCT number |
NCT01461317 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Genentech, Inc.
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Sponsor organisation address |
Grenzacherstrasse 124, Basel, Switzerland, CH-4070
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Public contact |
Roche Trial Information Hotline, Genentech, Inc., +41 616878333, global.trial_information@roche.com
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Scientific contact |
Roche Trial Information Hotline, Genentech, Inc., +41 616878333, global.trial_information@roche.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 |
08 Aug 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
08 Aug 2016
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Aug 2016
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The main objective of this study was to assess the long-term safety and tolerability of etrolizumab over an extended treatment period of up to 240 weeks.
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Protection of trial subjects |
All subjects were required to sign an informed consent form prior to study participation.
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Background therapy |
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Evidence for comparator |
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Actual start date of recruitment |
17 Nov 2011
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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 |
Canada: 11
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Country: Number of subjects enrolled |
United States: 11
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Country: Number of subjects enrolled |
Belgium: 30
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Country: Number of subjects enrolled |
Germany: 8
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Country: Number of subjects enrolled |
United Kingdom: 8
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Country: Number of subjects enrolled |
Spain: 1
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Country: Number of subjects enrolled |
Czech Republic: 11
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Country: Number of subjects enrolled |
Hungary: 6
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Country: Number of subjects enrolled |
Israel: 11
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Country: Number of subjects enrolled |
Australia: 5
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Country: Number of subjects enrolled |
New Zealand: 6
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Worldwide total number of subjects |
108
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EEA total number of subjects |
64
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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) |
103
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From 65 to 84 years |
5
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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 |
A total of 124 subjects at 40 sites were enrolled in the parent Study ABS4986g, and 118 were potentially eligible for inclusion in this extension study. Of these, 115 subjects were enrolled, and 108 received study drug. | ||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Study (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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Etrolizumab | ||||||||||||||||||||||||
Arm description |
Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks. | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Etrolizumab
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Investigational medicinal product code |
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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 |
Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Etrolizumab
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Reporting group description |
Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks. | ||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Etrolizumab
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Reporting group description |
Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks. | ||
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End point title |
Percentage of Subjects With Adverse Events (AEs) [1] | ||||||||
End point description |
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. The treated subjects population included any subject who received at least one dose of open-label study drug.
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End point type |
Primary
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End point timeframe |
From first dose of study drug to 12 weeks following last dose of study drug
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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 statistics only |
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| No statistical analyses for this end point | |||||||||
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End point title |
Number of Subjects With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab [2] | ||||||||||||||||||
End point description |
A positive ATA antibody sample was defined as one in which the presence of detectable ATAs could be confirmed by competitive binding with etrolizumab. Treatment-induced ATAs = a subject with a negative baseline result followed by a positive post-dose result. Treatment-enhanced ATAs = a subject with a positive baseline result followed by positive post dose result(s) of at least 0.6 titer units greater than the baseline titer. The treated subjects population included any subject who received at least one dose of open-label study drug.
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End point type |
Primary
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End point timeframe |
From first dose of study drug to 12 weeks following last dose of study drug (assessed at baseline, Week 4, Week 8, Week 12, every 12 weeks thereafter up to last dose and safety follow-up)
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| Notes [2] - 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 statistics only |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Serum Concentrations of Etrolizumab | ||||||||||||
End point description |
Minimum serum concentration among available samples collected with 35 days of at least 3 consecutive doses of either 300 mg or 100 mg of study drug. The treated subjects population included any subject who received at least one dose of open-label study drug.
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End point type |
Secondary
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End point timeframe |
From first dose of study drug to 12 weeks following last dose of study drug (assessed at baseline, Week 4, Week 8, Week 12, every 12 weeks thereafter up to last dose and safety follow-up)
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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 |
From first dose of study drug to 12 weeks following last dose of study drug.
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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 |
19.0
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Reporting groups
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Reporting group title |
Etrolizumab
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Reporting group description |
Etrolizumab 300 milligrams (mg), subcutaneous (SC) administration (dose lowered to 100 mg at 15 - 16 weeks after first dose) every 4 weeks during the treatment period, up to 240 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 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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28 Feb 2013 |
The dose of etrolizumab was lowered from 300 mg to 100 mg (subcutaneously) every 4 weeks. |
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04 Oct 2013 |
The dosing period was extended from 104 weeks to 180 weeks. |
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27 Jun 2015 |
The dosing period was extended from up to 180 weeks to up to Week 240. Added the option of transferring subjects within Study GA27927 to Study GA28951 for continued access to open-label etrolizumab. |
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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. | |||
| None reported | |||
