Clinical Trial Results:
A multicentre, open label, phase IIb clinical trial to evaluate safety, tolerability and efficacy of the depigmented modified allergen extract of two mites mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Lepidoglyphus destructor and DP/MG/14-2 Dermatophagoides pteronyssinus /Blomia tropicalis) in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled allergic asthma.
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Summary
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EudraCT number |
2014-000172-26 |
Trial protocol |
ES |
Global end of trial date |
09 May 2018
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Results information
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Results version number |
v2(current) |
This version publication date |
08 Jul 2022
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First version publication date |
12 Sep 2021
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Other versions |
v1 |
Version creation reason |
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Summary report(s) |
Synopsis Final Report |
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 |
1301-PG-PSC-203
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02340130 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
LETI Pharma S.L.U.
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Sponsor organisation address |
c/Sol nº 5, Madrid, Spain, 28760
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Public contact |
Medical Department, LETI Pharma S.L.U, +34 917711790, clinicalresearch@leti.com
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Scientific contact |
Medical Department, LETI Pharma S.L.U, +34 917711790, clinicalresearch@leti.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 |
31 May 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
09 May 2018
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Global end of trial reached? |
Yes
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Global end of trial date |
09 May 2018
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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 primary objective of this clinical trial is to evaluate the safety and tolerability of two allergens extract of mites mixes at 200 DPP/ml (DP/MG/14-1 Dermatophagoides pteronyssinus / Blomia tropicalis and DP/MG/14-2 Dermatophagoides pteronyssinus / Lepidoglyphus destructor) administered, using a rush build-up phase in subjects with allergic rhinitis or rhinoconjunctivitis, with controlled asthma.
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Protection of trial subjects |
The investigator requested the voluntary informed consent to he participants, after ensuring that study candidates have had understood what their participation in the study.
The investigator was responsible for informing study candidates about the study characteristics, nature, purpose, procedures, estimated duration, and potential risks and benefits associated with their participation, clearly explaining to them what their participation involved.
The investigator answered any questions that may have arisen and explained to the study candidates that their participation was voluntary.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Sep 2014
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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 |
Spain: 40
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Worldwide total number of subjects |
40
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EEA total number of subjects |
40
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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) |
40
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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 |
It was planned to include 34 subjects in each treatment group, and perform an interim safety analysis of the first 18 subjects. It was not possible because they were included only 7 subjects at one of the treatment group. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
They were selected for screening 43 subjects. | |||||||||||||||||||||
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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 |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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DP/MG/14-1 | |||||||||||||||||||||
Arm description |
D. pteronyssinus / B. tropicalis | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
D. pteronyssinus / B. tropicalis
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Investigational medicinal product code |
• DP/MG/14-1
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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 |
100/1000 DPP/ml, administering 0,5ml every 4-6 weeks
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Arm title
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DP/MG/14-2 | |||||||||||||||||||||
Arm description |
D. pteronyssinus / L. destructor | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
D. pteronyssinus / L. destructor
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Investigational medicinal product code |
DP/MG/14-2
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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 |
Dose 100/100 DPP/ml, administration 0,5ml every 4-6 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
Safety population | |||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
DP/MG/14-1
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Reporting group description |
D. pteronyssinus / B. tropicalis | ||
Reporting group title |
DP/MG/14-2
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Reporting group description |
D. pteronyssinus / L. destructor | ||
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End point title |
Safety | |||||||||
End point description |
Number of subjects (%) who experience at least one systemic reaction
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End point type |
Primary
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End point timeframe |
Study Safety Period
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Statistical analysis title |
Safety evaluation, systemic reactions | |||||||||
Statistical analysis description |
Subjects with immediate or delayed grade 2 or above systemic reaction
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Comparison groups |
DP/MG/14-1 v DP/MG/14-2
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Number of subjects included in analysis |
40
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Analysis specification |
Pre-specified
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Analysis type |
other | |||||||||
P-value |
= 0.05 | |||||||||
Method |
Wilcoxon (Mann-Whitney) | |||||||||
Parameter type |
Mean difference (final values) | |||||||||
Confidence interval |
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95% | |||||||||
sides |
2-sided
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lower limit |
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upper limit |
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Adverse events information
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Timeframe for reporting adverse events |
2 years treatment
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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 |
16.0
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Reporting groups
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Reporting group title |
Safety population
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Reporting group description |
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| Frequency threshold for reporting non-serious adverse events: 0.05% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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01 Feb 2016 |
Initial study design was modified to use two different concentrations of B. tropicalis (100/1000 DPP/ml and 100/500 DPP/ml), instead of the initial concentration foreseen (200 DPP/mL). An interim analysis was included and the possibility to an increase of the number of subjects to be included. |
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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 | |||||||
