In vivo biological standardization of Blomia tropicalis allergen extract.

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)

2025-08-14

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 Blomia tropicalis

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 Blomia tropicalis is prevalent
2. Age between 18 and 50 years, regardless of gender.
3. Patient diagnosed with IgE-mediated allergy to Blomia tropicalis allergen, meeting both of the following criteria: 1. Skin prick test with a wheal diameter at least ≥ 3 mm larger than that produced by the negative control used in the diagnostic panel. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher
4. Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
5. The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate

Exclusion criteria 8

1. That the patient has received treatment with specific immunotherapy with an extract of the allergen to be standardized and/or with other allergen(s) that may interfere with skin reactivity to the extract to be standardized (cross-reactivity/homologous groups) in the last 5 years
2. The administration of drugs capable of interfering with the results of the SPT, including antihistamines (H1 and H2 blockers) or cromoglycate, which cannot be discontinued for the skin tests
3. That the patient has lesions or tattoos on the skin area where the tests will be performed, and at the time of the tests, these could influence the proper evaluation of the same
4. Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), breastfeeding, dermatographism, atopic dermatitis (affecting the test area), urticaria, or any other skin disease affecting the area where the skin tests for standardization should be performed.
5. Patient's inability to understand the objective/purpose of the study.
6. Patient's inability/refusal to sign the informed consent for participation in the study.
7. Hypersensivity to any of the excipients 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 (not inhaled).

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

Flava Tamara Hernandez

Public contact point

Organisation

Asac Pharmaceutical Inmunology S.A.

Contact name

Monica Escorial

Third parties 1

Sponsor responsibilities

Contact point sponsor

Asac Pharmaceutical Inmunology S.A.

Locations

1 EU/EEA country · 2 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

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