Clinical Trial Results:
A phase IIIB trial investigating 3-year treatment efficacy, tolerability and safety of Grazax in children aged 5-18 years with grass pollen induced rhinoconjunctivitis with/without controlled asthma ( three consecutive pollen seasons treatment)
Summary
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EudraCT number |
2009-014923-22 |
Trial protocol |
IT |
Global end of trial date |
31 Dec 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
26 Jul 2015
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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 |
GT-23
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
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WHO universal trial number (UTN) |
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Sponsors
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Sponsor organisation name |
ALK-Abellò S.p.A
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Sponsor organisation address |
Via Settembrini, 29, LAINATE, Italy, 20020
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Public contact |
Global Clinical Development, ALK, 45 45747576, ClinicalTrials@alk.net
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Scientific contact |
Global Clinical Development, ALK, 45 45747576, ClinicalTrials@alk.net
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
31 Dec 2014
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
31 Dec 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
31 Dec 2014
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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 |
To evaluate the 3 years efficacy, tolerability, safety of specific immunotherapy with Grazax compared to placebo on the top of rescue allergic symptomatic drugs in children with grass pollen induced rhinoconjunctivitis with or without controlled or partly controlled asthma.
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Protection of trial subjects |
Rescue medication allowed, safety monitoring
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Background therapy |
As required by the underlying clinical conditions (allergic rhinitis with or without allergic asthma) | ||
Evidence for comparator |
N/A. Placebo comparator | ||
Actual start date of recruitment |
03 Oct 2010
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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 |
Italy: 68
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Worldwide total number of subjects |
68
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EEA total number of subjects |
68
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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) |
48
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Adolescents (12-17 years) |
20
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Adults (18-64 years) |
0
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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 |
- | ||||||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Children were recruited in 11 different sites in Italy. The patients were recruited either prior to the 2010 grass pollen season or prior to the 2011 grass pollen season. | ||||||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator, Monitor, Data analyst, Carer, Assessor | ||||||||||||||||||||||||||||||||||||
Blinding implementation details |
Placebo and active treatment were idential in colour, taste and appearance
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||||||
Arm description |
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Arm type |
Placebo | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Sublingual use
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Dosage and administration details |
One tablet per day; the tablet should be taken from the blister unit with dry fingers, and placed under the tongue, where it will disperse.
Swallowing should be avoided for about 1 minute. Food and beverage should not be taken for the following 5 minutes.
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Arm title
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Grazax | ||||||||||||||||||||||||||||||||||||
Arm description |
Active treatment | ||||||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Grazax
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Orodispersible tablet
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Routes of administration |
Sublingual use
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Dosage and administration details |
One tablet per day; the tablet should be taken from the blister unit with dry fingers, and placed under the tongue, where it will disperse.
Swallowing should be avoided for about 1 minute. Food and beverage should not be taken for the following 5 minutes.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Grazax
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Reporting group description |
Active treatment | ||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
- | ||
Reporting group title |
Grazax
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Reporting group description |
Active treatment |
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End point title |
IMP-related AEs [1] | |||||||||
End point description |
Adverse events with possible causal relationship to IMP
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End point type |
Primary
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End point timeframe |
From randomisation to end of trial
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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: GT-23 was changed to a safety and tolerability trial for two reasons: 1) after the first two years of recruitment, the sample size was underpowered to make any statistical analysis of endpoints originally chosen; 2) patients were recruited and studied in each site in different pollen seasons (2010, 2011, and 2012; or 2011, 2012, and 2013), thus exposing them to different pollen counts. Thus not formal statistical analyses was carried out and the primary endpoint was merely descriptive. |
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No statistical analyses for this end point |
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End point title |
Severe AE | |||||||||
End point description |
Adverse events assessed as severe
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End point type |
Secondary
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End point timeframe |
From randomisation to end of trial
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No statistical analyses for this end point |
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End point title |
Global evaluation | ||||||||||||
End point description |
In subjects opinion, 'much better' season than before treatment
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End point type |
Secondary
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End point timeframe |
3rd treatment year/grass pollen season
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Notes [2] - All subjects continuing in year 3 [3] - All subjects continuing in year 3 |
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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 randomisation to end of trial (March 2010 to June 2014)
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||
Dictionary version |
17.0
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Reporting groups
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Reporting group title |
Placebo
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Reporting group description |
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Reporting group title |
Grazax
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Reporting group description |
- | |||||||||||||||||||||||||||||||||
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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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14 May 2012 |
Changed with amendment-1 from phase IIIB efficacy study to safety study for 2 reasons: firstly, after the first two years of recruitment, the sample size was underpowered to make any statistical analysis of endpoints originally chosen; secondly, patients were recruited and studied in each Centre in different pollen seasons (2010, 2011, and 2012; or 2011, 2012, and 2013), thus exposing them to different pollen counts. |
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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. | |||
NA |