In vivo biological standardization of Dermatophagoides 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]

Trial duration

11 Apr 2025 → ongoing

Decision date (initial)

2025-03-14

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To evaluate the sensitivity and specificity of standardised Dermatophagoides pteronyssinus and Dermatophagoides farinae allergenic extracts for the diagnosis of IgE-mediated sensitisation.

Conditions and MedDRA coding

Allergies

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Adult subjects aged 18 to 60 years, regardless of sex.
2. Subjects able to understand the nature and purpose of the study and who have provided written informed consent.
3. Subjects residing in a geographic area where Dermatophagoides pteronyssinus and Dermatophagoides farinae allergens are prevalent
4. For sensitivity assessment: Subjects with confirmed IgE-mediated allergy to Dermatophagoides pteronyssinus and D. farinae, demonstrated by positive skin prick tests performed according to routine diagnostic procedures at the investigational site.
5. For specificity assessment: Subjects without clinical manifestations suggestive of allergy to Dermatophagoides pteronyssinus and D. farinae, and with negative skin prick tests to both allergens performed according to routine diagnostic procedures at the investigational site.

Exclusion criteria 7

1. Previous treatment with specific immunotherapy with Dermatophagoides extracts or other allergens that may interfere with skin reactivity within the last 5 years.
2. Use of medications that may interfere with skin prick testing, such as antihistamines or cromoglycate, that cannot be discontinued prior to testing.
3. Presence of skin lesions, tattoos or dermatological conditions at the test site that may interfere with the proper evaluation of skin prick test results.
4. Presence of conditions that may alter skin test responses, including pregnancy or lactation, dermographism, atopic dermatitis affecting the test area, urticaria or other relevant skin diseases.
5. Known hypersensitivity to any excipient of the investigational medicinal product.
6. Treatment with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, tricyclic antidepressants or systemic corticosteroids (non-inhaled).
7. Inability to understand the purpose of the study or refusal to provide written informed consent.

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 2

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

Mónica Escorial

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

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

Documents 6 files

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

Application history

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