In vivo biological standardization of Olea europaea allergen extracts.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Asac Pharmaceutical Inmunology S.A.

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

Decision date (initial)

2026-02-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

ASAC PHARMACEUTICAL INMUNOLOGY SA

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

Biological standardization of the allergenic extract of Olea europaea

Conditions and MedDRA coding

Allergies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Patient residing in a geographic area where Olea europaea is prevalent
2. Age between 18 and 50 years, regardless of gender.
3. Patient diagnosed with IgE-mediated allergy to the Olea europaea allergen, meeting both of the following criteria: 1. Positive skin prick test to the allergen, with a wheal whose mean diameter is at least ≥ 3 mm greater than that produced by the negative control included in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) to the allergen, class 1 or higher.
4. Mean wheal diameter ≥ 4 mm induced by a 10 mg/mL histamine dihydrochloride solution (positive control).
5. The patient must be capable of understanding the purpose and scope of the study and must have signed the informed consent form to participate.

Exclusion criteria 8

1. The patient has received specific allergen immunotherapy with the extract to be standardized and/or with other allergen(s) that may interfere with the skin reactivity to the extract being standardized (cross-reactivity/homologous groups) within the past 5 years.
2. Use of medications that may interfere with the results of the skin prick test (SPT), including antihistamines (H1 and H2 receptor antagonists) or cromolyn sodium, and that cannot be discontinued prior to skin testing.
3. Presence of lesions or tattoos on the skin area where the tests are to be performed, which at the time of testing may interfere with accurate assessment.
4. Any condition that may alter the patient’s response to the SPT, such as: pregnancy (in case of suspicion, a pregnancy test should be performed), breastfeeding, dermographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests are to be conducted for standardization.
5. Inability of the patient to understand the purpose or objectives of the study.
6. Inability or refusal of the patient to sign the informed consent to participate in the study.
7. Hypersensitivity to any of the excipients included in the investigational product.
8. Treatment with beta-blockers or angiotensin-converting enzyme (ACE) inhibitors, as well as chronic treatment with tricyclic antidepressants and/or systemic corticosteroids (excluding inhaled corticosteroids).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. The area of the wheal (mm2) that occurs at the cutaneous level after the administration of the extracts in the prick test for the calculation of the primary endpoint.
2. Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
3. Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml

Secondary endpoints 1

1. Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Asac Pharmaceutical Inmunology S.A.

Sponsor organisation

Asac Pharmaceutical Inmunology S.A.

Address

Calle Capricornio 3-5

City

Alicante

Postcode

03006

Country

Spain

Scientific contact point

Organisation

Asac Pharmaceutical Inmunology S.A.

Contact name

FLAVIA TAMARA HERNÁNDEZ

Public contact point

Organisation

Asac Pharmaceutical Inmunology S.A.

Contact name

FLAVIA TAMARA HERNÁNDEZ

Third parties 1

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications