OLEA EUROPAEA POLLEN EXTRACT for Allergies

Inclusion criteria

• {"criterion_text":"- Patient residing in a geographic area where Olea europaea is prevalent"}
• {"criterion_text":"- Age between 18 and 50 years, regardless of gender."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Mean wheal diameter ≥ 4 mm induced by a 10 mg/mL histamine dihydrochloride solution (positive control)."}
• {"criterion_text":"- 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

• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Inability of the patient to understand the purpose or objectives of the study."}
• {"criterion_text":"- Inability or refusal of the patient to sign the informed consent to participate in the study."}
• {"criterion_text":"- Hypersensitivity to any of the excipients included in the investigational product."}
• {"criterion_text":"- 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)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measurement: area of the wheal in mm2 measured at the cutaneous level after administration of extracts in the prick test."}
• {"endpoint_text":"- Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.","definition_or_measurement_approach":"Measurement: regression analysis of wheal area values versus extract concentration (PNU/ml) to estimate dose/response relationship."}
• {"endpoint_text":"- Determination of the theoretical concentration of extract that produces a papule equivalent to that produced by a solution of histamine at 10 mg/ml","definition_or_measurement_approach":"Measurement: calculation/estimation of the extract concentration producing an equivalent papule to histamine 10 mg/ml based on dose-response data."}

Secondary endpoints

• {"endpoint_text":"- Safety assessment through descriptive analysis of adverse reactions that could occur during the course of the study","definition_or_measurement_approach":"Measurement: descriptive analysis of adverse reactions occurring during the study (safety reporting)."}

Spain

Earliest CTIS Part Ii Submission Date

11-10-2025

Latest Decision Or Authorization Date

25-02-2026

Processing Time Days

137

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Asac Pharmaceutical Inmunology S.A.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain

Contract research organisations

Name

Advanced Outcomes Research S.L.

Responsibilities

Sponsor duties codes: [1,10,12,5,6]; contact csantos@aorsl.com

Third parties

• {"country":"Spain","full_name":"Advanced Outcomes Research S.L.","duties_or_roles":"Sponsor duties codes: [1,10,12,5,6]","organisation_type":"Pharmaceutical company"}