Biological Standardisation of Allergenic Extracts of Mites to Determine Biological Activity (in Hep Units) in Sensitivised Patients.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas 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

1 Oct 2024 → 23 Jul 2025

Decision date (initial)

2024-08-29

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

The main objective is to evaluate in vivo the concentration of allergenic extracts of mites (Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis and Lepidoglyphus destructor) that cause a papule of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/ml.
Standardize mite allergenic extracts in biological units.

Secondary objectives 2

1. To determine the in vitro biological potency of the concentration of mite extracts that induce a wheal equivalent in size to that produced by a 10 mg/ml histamine dihydrochloride solution, ensuring consistency and reproducibility.
2. Evaluation of the tolerability and safety of the drugs under study

Conditions and MedDRA coding

Allergies

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. The age of the patients will range between 18 and 65 years, both inclusive.
2. Patient who has provided informed consent to participate in the study.
3. Previous medical history supporting the diagnosis of allergy
4. Demonstrated sensitization to allergens (at least to one of the following allergens: Dermatophagoides pteronyssinus, Dermatophagoides farinae, Blomia tropicalis, and Lepidoglyphus destructor responsible for the patient's clinical symptoms) through:    - Skin prick test (Prick test), with a positivity criterion when the largest diameter of the wheal obtained with a standardized commercial extract is ≥ 3 mm compared to the negative control.    - Specific IgE serum to the allergen equal to or greater than 3.5 kUA/L (CAP).   Both the skin prick test and the specific IgE will be valid if performed within the 18 months prior to study inclusion.
5. Negative pregnancy test in urine for potentially fertile women (fertile is understood from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy).

Exclusion criteria 14

1. Having received previous immunotherapy treatment during the 5 years prior to study inclusion with an allergenic extract of any type of mites.
2. Having taken oral H1 antihistamines (first or second generation) in the 7 days prior to study inclusion
3. Psychiatric disorder that prevents adequate compliance with the immunotherapy program. If taking psychiatric medication that interferes with the diagnostic test (e.g., tricyclic antidepressants), it should not be discontinued to be included in the study.
4. Use of beta-blockers or any medication contraindicating the use of adrenaline. If the drug is necessary to preserve the patient's health, it should not be discontinued to be included in the study.
5. Chronic use of oral corticosteroids, or oral or parenteral corticosteroid use in repeated and intermittent regimens (> 10 mg/day of prednisone or equivalent).
6. Dermographism, lesions, and/or any cutaneous pathology (including dermatitis and urticaria) affecting the area where skin tests are performed.
7. Hypersensitivity to any component of the skin prick test
8. Treatment with pimecrolimus and/or topical corticosteroids in the area where skin tests are performed in the last 21 days prior to study inclusion
9. Clinically relevant immune system diseases, both autoimmune and immunodeficiencies, at the investigator's discretion
10. Uncontrolled severe diseases that may increase the risk to the safety of patients participating in this study.
11. Patients with a history of severe reactions during previous skin tests.
12. Patients receiving anti-IgE, anti-IL 5, anti-IL 4 or IL-13 biological therapy, or anti-eosinophil (Omalizumab, Dupilumab, Benralizumab, Reslizumab, Mepolizumab) or have been receiving it in the last 6 months.
13. Simultaneous participation in another clinical trial.
14. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

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

Secondary endpoints 2

1. To determine the in vitro biological potency expressed as HEP (1 HEP = 10,000 biological units) of the concentration of the investigational product that elicits a wheal of a size equivalent to that produced by a solution of histamine dihydrochloride at 10 mg/ml.
2. Safety assessment through descriptive analysis of adverse reactions that may occur during the course of the study.

Investigational products

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

Test 4

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Sponsor organisation

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Address

Avenida De Gregorio Peces Barba 2

City

Leganes

Postcode

28919

Country

Spain

Scientific contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Dra. Carmen Santos

Public contact point

Organisation

Advanced Outcomes Research S.L.

Contact name

Dra. Carmen Santos

Third parties 1

Sponsor responsibilities

Contact point sponsor

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Locations

1 EU/EEA country · 3 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 2 files

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

Application history

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