Clinical Trial Results:
Juniperus oxycedrus and Cupressus arizonica allergen extracts. Determination of the in vivo allergenic potency in histamine equivalent units (HEP).
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Summary
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EudraCT number |
2020-005389-32 |
Trial protocol |
ES |
Global end of trial date |
05 Feb 2024
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Oct 2025
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First version publication date |
26 Oct 2025
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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 |
T521-STD-044
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Inmunotek, S.L
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Sponsor organisation address |
Punto Mobi, 5, Alcalá de Henares, Spain, 28805
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Public contact |
Miguel Casanovas; Medical Director, Inmunotek, S.L., 34 912908942, mcasanovas@inmunotek.com
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Scientific contact |
Miguel Casanovas; Medical Director, Inmunotek, S.L., 34 912908942, mcasanovas@inmunotek.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 |
19 Dec 2024
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
05 Dec 2023
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Global end of trial reached? |
Yes
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Global end of trial date |
05 Feb 2024
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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 is to evaluate the concentration of allergenic extract of Juniperus oxycedrus and Cupressus arizonica that elicits a wheal of a equivalent size to that produced by a solution of histamine dihydrochlorohydrochloride at 10 mg/mL.
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Protection of trial subjects |
According to GCP, written informed consent has to be obtained prior to each subject's participation in the trial.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
12 Dec 2022
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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 |
Spain: 30
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Worldwide total number of subjects |
30
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EEA total number of subjects |
30
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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) |
29
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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 |
- | |||||||||
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Pre-assignment
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Screening details |
Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Juniperus oxycedrus and Cupressus arizonica. | |||||||||
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Period 1
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Period 1 title |
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 |
No
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Arm title
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Prick test Juniperus oxycedrus | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Histamine dyhidrochloride solution
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Investigational medicinal product code |
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Other name |
Positive control
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
10 mg/mL
One drop in duplicate on the forearm
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Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
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Other name |
Negative control
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
One drop in duplicate on the forearm.
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Investigational medicinal product name |
Juniperus oxycedrus allergen extract
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
An allergen extract of Juniperus oxycedrus with a concentration of 300 µg/mL. Two dilutions of 60 and 12 µg/mL were prepared from the allergen extract. One drop in duplicate of each concentration on the forearm was tested.
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Arm title
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Prick test Cupressus arizonica | |||||||||
Arm description |
- | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Histamine dyhidrochloride solution
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Investigational medicinal product code |
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Other name |
Positive control
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
10 mg/mL. One drop in duplicate on the forearm.
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Investigational medicinal product name |
Saline solution
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Investigational medicinal product code |
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Other name |
Negative control
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
One drop in duplicate on the forearm.
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Investigational medicinal product name |
Cupressus arizonica allergen extract
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection/skin-prick test
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Routes of administration |
Cutaneous use
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Dosage and administration details |
An allergen extract of Cupressus arizonica with a concentration of 100 µg/mL. Two dilutions of 20 and 4 µg/mL were prepared from the allergen extract. One drop in duplicate of each concentration on the forearm was tested.
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Baseline characteristics reporting groups
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Reporting group title |
Prick test Juniperus oxycedrus
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Reporting group description |
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Reporting group title |
Prick test Cupressus arizonica
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Reporting group description |
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End points reporting groups
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Reporting group title |
Prick test Juniperus oxycedrus
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Reporting group description |
- | ||
Reporting group title |
Prick test Cupressus arizonica
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Reporting group description |
- | ||
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End point title |
Size of the wheal induced by each concentration [1] | |||||||||
End point description |
The size of the wheal produced by each different concentration of the allergen extract and the controls through the prick test were measured to determine biological potency.
15 minutes after the application of each solution onto the skin, the contour of every wheal was encircled using the Prick-Film® System.
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End point type |
Primary
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End point timeframe |
The total duration of the study for a patient was approximately 2 hours (visit 1).
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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: Statistical results were not relevant for publish |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
The total duration of the study for a patient was approximately 2 hours.
No adverse events during the reporting period.
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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 |
27.0
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| Frequency threshold for reporting non-serious adverse events: 0% | |||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: No adverse events during the reporting period |
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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. | |||
| Not applicable | |||
