ClinicalTrials.gg
RecruitingNCT05532566Updated May 1, 2025

Quercus Ilex and Quercus Robur Allergen Extracts Standardisation

An interventional study of Allergenic extract in Allergic Reaction, Allergic Skin Reaction and Allergy Pollen, sponsored by Inmunotek S.L.. Recruiting at 1 site in Spain. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-05-01.

Primary conditionRhinitis, Allergic, SeasonalRegistry: HypersensitivityReclassifiedWhy we changed it
Registry
Hypersensitivity — the first condition term the registry derived for this study.
ClinicalTrials.gg
Rhinitis, Allergic, Seasonal
Why
  1. The study's listed conditions name Rhinitis, Allergic, Seasonal, a narrower term within Hypersensitivity.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Inmunotek S.L. · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Nov 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 9 months later.

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Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 64 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 10 studies in Rhinitis, Allergic, Seasonal with a site in Spain — 1 open to participants now, 1 under way, none of them phase 3. Rhinitis, Allergic, Seasonal · Spain.

Planned enrollment
5th of 10
30 · median 30
Started
2023
with 1 other
No phase
3 of 10
1 open now
Registered
8th of 10
by date
Lead sponsor
4 of 10
Inmunotek S.L.

Among the 10 studies in Rhinitis, Allergic, Seasonal with a site in Spain, this one is the 5th largest by planned enrollment, is one of 2 that started in 2023, is one of 3 with no phase, and was the 8th registered.

Rhinitis, Allergic, Seasonal

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

Browse Rhinitis, Allergic, Seasonal studies →

Open to participants now

1 of the 10 studies in Rhinitis, Allergic, Seasonal with a site in Spain is open now.

A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →

Who these studies take

Of the 17 Rhinitis, Allergic, Seasonal studies recruiting now, 2 (12%) set no upper age limit and 15 (88%) stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 18 Years to 64 Years · all sexes · no healthy volunteers.

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02

Study summary

The objective of this study is to determine the biological activity of Quercus illex and Quercus robur allergen extracts in histamine equivalent prick (HEP) units, in order to be used as in-house reference preparation (IHRP).

Read the detailed description

The trial will consist of a single visit, in which the following procedures will be carried out:

  • Demographic data.
  • Clinical history.
  • Inclusion/exclusion criteria.
  • General examination.
  • Performance of prick-tests (3 concentrations of Quercus ilex allergenic extract, 3 concentrations of Quercus robur allergenic extract, positive control and negative control).
  • Obtaining a blood sample from the patient to create a pool of sera for the "in vitro" standardization of the allergenic extract. This pool of sera is necessary for the characterization of the Company's standard. Each serum sample will be stored in a tube that will be labeled with the subject number and frozen. These serum samples will remain in the freezer until the study is completed. When the study is completed, they will be transported to the laboratory, where all sera will be pooled. This "pool" of sera will be used to perform the complementary in vitro standardization tests. These include ELISA for measurement of inhibition against specific IgE, etc. These serum samples are not destroyed. They are pooled together to form a pool that will be used, as described in the previous paragraph, in all the in vitro tests necessary to standardize and characterize this extract and produce its corresponding HIRP (In-house reference preparation), as indicated by the Royal Spanish Pharmacopoeia and the European Pharmacopoeia. This pool of sera is not destroyed, it is used in the in vitro analyses necessary for the standardization of new batches of this allergenic extract. Once the pool has been formed, the tubes containing the original serum samples are destroyed.
  • Evaluation of adverse events.
03

Conditions studied

  • Allergic Reaction
  • Allergic Skin Reaction
  • Allergy Pollen

Browse trials for

Keywords

  • Allergy
04

In context

Rhinitis, Allergic, Seasonal Reclassified

404 studies on the registry are indexed under Rhinitis, Allergic, Seasonal; 24 are open to participants now.

This study's planned enrollment of 30 is below the median of 131 across 366 interventional studies indexed under Rhinitis, Allergic, Seasonal.

Browse Rhinitis, Allergic, Seasonal studies →

Lead sponsor

Inmunotek S.L. is the lead sponsor of 26 studies on the registry; 13 are open to participants now.

Compared within Rhinitis, Allergic, Seasonal, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypersensitivity. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Subjects must live in a geographical area where allergic problems caused by Quercus ilex and Quercus robur are relevant.
  • Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to asthma) to Quercus ilex and Quercus robur.
  • A positive prick-test (mean papule diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE against that allergen.
  • The mean papule area obtained with Histamine dichlorhydrate at 10 mg/mL should be ≥ 7 mm2.
  • Age: Between 18 and 64 years old.
  • Subjects must be able to give .

Exclusion criteria

Exclusion Criteria:

  • Subjects should not be excluded in terms of low or high sensitivity to Quercus ilex and Quercus robur.
  • Subjects outside the age range.
  • Subjects who have previously received immunotherapy in the last 5 years for the treatment of asthma or rhinoconjunctivitis for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Quercus ilex and Quercus robur extracts.
  • Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in which the suspension of the systemic antihistamine treatment is .
  • Subjects who have previously presented a severe secondary reaction during the performance of diagnostic skin tests by prick test.
  • Subjects under treatment with ß-blockers.
  • Subjects clinically unstable (acute asthma, febrile, etc.).
  • Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
  • Subjects with active viral infection by herpes simplex or herpes varicella zoster in the area where the prick test is performed.
  • Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, HTA, cardiopathy, etc.).
  • States of the subject in which he/she cannot offer cooperation and severe psychiatric disorders.
  • Pregnant women or women at risk of pregnancy and lactating women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

06

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Extract Q. ilex + extract Q. robur + positive control + negative control

    There is only one treatment arm. In each subject, one drop of each of the 3 concentrations of each allergenic extract (2 extracts) will be applied in addition to the positive control (histamine 10mg/mL) and the negative control, with prick test. Quercus ilex: 2,500, 500 and 100 μg/mL Quercus robur: 2,500, 500 and 100 μg/mL

    Other: Allergenic extract

Interventions

  • OtherAllergenic extract

    In each subject a drop of each of the 3 concentrations of both allergenic extracts will be applied in addition to the positive control (histamine) and the negative control. The application will be made in duplicate on the anterior face of the subject's arm. The distance between each application should be approximately 4 cm.

    Also known as: Allergenic Quercus ilex and Quercus robur extract

07

What researchers measure

Primary outcomes

  1. Size of the induced papule on the skin

    Size of the induced papule on the skin when applying each of the concentrations of the allergenic extracts and the positive (histamine) and negative controls, using the prick test.

    Time frame: 15 minutes

  2. Adverse reactions

    Mild secondary reactions such as pruritus, erythema, local edema, etc. There is a risk, infrequent and exceptional, of systemic reactions, sometimes severe (urticaria, asthma, anaphylactic shock, etc.).

    Time frame: 30 minutes

08

Study locations

1 of 1 sites recruiting
  • Clínica Subiza, centro de asma y alergia
    Madrid, Spain
    Recruiting
    • Javier Subiza, DM · Principal investigator
09

References and documents

Publications

  • Sjoholm I. Standardisation of allergens in Europe. Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M. 1997;(91):107-10. PubMed 9383897 ↗
  • Larsen JN, Dreborg S. Standardization of Allergen Extracts. Methods Mol Biol. 2019;2020:63-76. doi: 10.1007/978-1-4939-9591-2_5. PubMed 31177492 ↗
  • Arntzen FC. Progress in common Nordic Guidelines for the Registration of Allergen Preparations. Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M. 1983;(78):25-8. No abstract available. PubMed 6625583 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2023 (actual). Primary completion is estimated for Nov 2025, 34 months after the start.

Of 22 interventional studies with no phase under Rhinitis, Allergic, Seasonal, half reached primary completion within 7 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 22. This study's planned 34 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2022
First posted
Sep 8, 2022
StartActual
Jan 24, 2023
Primary completionEst.
Nov 30, 2025
CompletionEst.
Nov 30, 2025
Last update
May 1, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05532566
Lead sponsor
Inmunotek S.L.
Responsible party
Sponsor
First posted
Sep 8, 2022
Start date
Jan 24, 2023
Primary completion
Nov 30, 2025 (estimated)
Completion
Nov 30, 2025 (estimated)
Last update
May 1, 2025

Study contacts

Miguel Casanovas, MD
Contact
mcasanovas@inmunotek.com
+34912908942
Raquel Caballero, BSc
Contact
rcaballero@inmunotek.com
+34607600638
Javier Subiza, MD
principal investigator · Clinica Subiza, centro de asma y alergia

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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