Clinical Trial Results:
Effect of Intralymphatic Immunotherapy on Basophil Response and Plasma Cell Kinetics in Allergic Patients
Summary
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EudraCT number |
2012-005227-33 |
Trial protocol |
DK |
Global end of trial date |
14 Aug 2016
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Results information
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Results version number |
v1(current) |
This version publication date |
22 Feb 2020
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First version publication date |
22 Feb 2020
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Other versions |
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Summary report(s) |
CTA_article_SchmidJM |
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 |
ILIT_2013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Aarhus Universitets Hospital
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Sponsor organisation address |
Palle Juul-Jensens Boulevard 99, Aarhus N, Denmark, 8200
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Public contact |
ILIT, Department of Respiratory Diseases, 0045 78462106,
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Scientific contact |
PILIT, Department of Respiratory Diseases, +45 78462106,
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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 |
01 Mar 2016
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
16 Aug 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
14 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 |
We would like to evaluate the effect of Intralymphatic Immunotherpy (ILIT) on patients with rhinoconjunctivitis due to grass pollen allergy.
1. Is the clinical effect comparable to that of Subcutaneous Immunotherapy (SCIT) measured in BasoSCIT (funded by Lundbeck grant R32-A1482)
2. Does a booster injection after one year confer additional symptom relief
3. Can enumerating plasma cells one week after injection monitor ILIT?
4. Is the effect on Basophil activation (BAT EC50) a useful tool to document clinical effect?
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Protection of trial subjects |
Minimum numbers of injections performed in participants.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
01 Feb 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 36
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Worldwide total number of subjects |
36
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EEA total number of subjects |
36
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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) |
36
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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 |
Screening and inclusion according to criteria. | ||||||||||||||||||||||||
Pre-assignment
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Screening details |
Screening criteria: Grass pollen allergy. | ||||||||||||||||||||||||
Period 1
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Period 1 title |
Overall (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 | ||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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4 ILIT | ||||||||||||||||||||||||
Arm description |
3 intralymphatic injections and 1 booster injection | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000 SQU.
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Arm title
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3 ILIT | ||||||||||||||||||||||||
Arm description |
3 ILIT injections and one placebo booster injection | ||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||
Investigational medicinal product name |
Alk 225. Phleum Pratense
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Concentrate for solution for injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
1000 SQU.
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Arm title
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Placebo | ||||||||||||||||||||||||
Arm description |
3 placebo injections and one placebo booster | ||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||
Investigational medicinal product name |
NaCl
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intralymphatic use
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Dosage and administration details |
0.1 ml NaCl as placebo.
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Baseline characteristics reporting groups
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Reporting group title |
4 ILIT
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Reporting group description |
3 intralymphatic injections and 1 booster injection | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
3 ILIT
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Reporting group description |
3 ILIT injections and one placebo booster injection | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
3 placebo injections and one placebo booster | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
4 ILIT
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Reporting group description |
3 intralymphatic injections and 1 booster injection | ||
Reporting group title |
3 ILIT
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Reporting group description |
3 ILIT injections and one placebo booster injection | ||
Reporting group title |
Placebo
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Reporting group description |
3 placebo injections and one placebo booster |
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End point title |
cSMS | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
3 years follow up
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Statistical analysis title |
Median | ||||||||||||||||
Comparison groups |
4 ILIT v 3 ILIT v Placebo
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Number of subjects included in analysis |
30
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
< 0.05 | ||||||||||||||||
Method |
ANOVA | ||||||||||||||||
Parameter type |
Median difference (final values) | ||||||||||||||||
Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
- | ||||||||||||||||
upper limit |
- |
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Adverse events information
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Timeframe for reporting adverse events |
3 years
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Acording to protocol | ||||||||||||||||||||||||||||||||
Dictionary version |
1
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Reporting groups
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Reporting group title |
4 ILIT
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Reporting group description |
3 intralymphatic injections and 1 booster injection | ||||||||||||||||||||||||||||||||
Reporting group title |
3 ILIT
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Reporting group description |
3 ILIT injections and one placebo booster injection | ||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
3 placebo injections and one placebo booster | ||||||||||||||||||||||||||||||||
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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. | |||
None reported |