Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Not authorised
Participants planned
96
Countries
1
Sites
2
Allergies
• Biological standardization of the allergenic extract of Dermatophagoides pteronyssinus, representative of the homologous group of Dermatophagoides mites – 1st PHASE • Based on the concentration of Dermatophagoides pteronyssinus determined in the 1st phase, assess the sensitivity and specificity of the Dermatophagoide…
Key facts
- Sponsor
- Advanced Outcomes Research S.L., 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)
- 2024-09-09
- 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
• Biological standardization of the allergenic extract of Dermatophagoides pteronyssinus, representative of the homologous group of Dermatophagoides mites – 1st PHASE
• Based on the concentration of Dermatophagoides pteronyssinus determined in the 1st phase, assess the sensitivity and specificity of the Dermatophagoides pteronyssinus extract and the Dermatophagoides farinae extract. – 2nd PHASE
Conditions and MedDRA coding
Allergies
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- 1st PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).
- 2nd PHASE: Mean wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 2nd PHASE: Mean wheal diameter < 3 mm induced by the negative control.
- 1st PHASE: Age between 18 and 50 years, regardless of gender.
- 1st PHASE: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus 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.
- 1st PHASE: Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 1st PHASE: The patient must be able to understand the purpose and scope of the study and must have signed the informed consent to participate
- 2nd PHASE: Patient residing in a geographic area where Dermatophagoides pteronyssinus and/or Dermatophagoides farinae is prevalent (e.g., Mediterranean coast due to its humidity and mild temperatures).
- 2nd PHASE: Age between 18 and 50 years, regardless of sex.
- 2nd PHASE: To determine the sensitivity of the extract: Patient diagnosed with IgE-mediated allergy to the Dermatophagoides pteronyssinus allergen and/or any allergen from its homologous group (Dermatophagoides farinae), meeting both of the following criteria: 1. Positive skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Positive specific IgE (in vitro diagnostic test) of class 1 or higher.mm larger than that produced by the negative control used in the diagnostic battery. 2. Positive specific IgE (in vitro diagnostic test) class 1 or higher.
- 2nd PHASE : To determine the specificity of the extract: Patient in whom possible IgE-mediated sensitization to Dermatophagoides pteronyssinus or any allergen from its homologous group (Dermatophagoides farinae) has been ruled out, meeting both of the following criteria: 1. Negative skin prick test according to the standard diagnostic procedures of the investigator's center. 2. Negative specific IgE (in vitro diagnostic test).
- 2nd PHASE: 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
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: 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.
- 1st and 2nd PHASE: Any process that may alter the patient's response to the SPT, such as: pregnancy (in case of suspicion, perform a pregnancy test), 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.
- 1st and 2nd PHASE : Patient's inability to understand the objective/purpose of the study.
- 1st and 2nd PHASE: Patient's inability/refusal to sign the informed consent for participation in the study.
- 1st and 2nd PHASE: Hypersensivity to any of the excipients in the investigational product.
- 1st and 2nd PHASE: 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
- 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.
- Estimation of the dose/response relationship in each patient; regression analysis of area values versus concentration in PNU/ml.
- 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 2
- Evaluation of the sensitivity and specificity of the extract concentration defined in the main objective of the study.
- 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
Diagnóstico prick Dermatophagoides pteronyssinus
PRD11295922 · Product
- Active substance
- Dermatophagoides Pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Diagnóstico prick Dermatophagoides pteronyssinus
PRD11470750 · Product
- Active substance
- Dermatophagoides Pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Diagnóstico prick Dermatophagoides pteronyssinus
PRD11470674 · Product
- Active substance
- Dermatophagoides Pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Diagnóstico prick Dermatophagoides pteronyssinus
PRD11470617 · Product
- Active substance
- Dermatophagoides Pteronyssinus
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
Diagnóstico prick control positivo
PRD11295687 · Product
- Active substance
- Histamine Dihydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Diagnóstico prick control negativo
PRD11295652 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 10 mg/ml milligram(s)/millilitre
- Max total dose
- 10 mg/ml milligram(s)/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- ASAC PHARMACEUTICAL INMUNOLOGY
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Advanced Outcomes Research S.L.
- Sponsor organisation
- Advanced Outcomes Research S.L.
- Address
- Calle De Tarragona 84-90 Esc C 2ª-7
- City
- Barcelona
- Postcode
- 08015
- 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
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 Hernández
Public contact point
- Organisation
- Advanced Outcomes Research S.L.
- Contact name
- Carmen Santos
Sponsor responsibilities
- Contact point sponsor
- Advanced Outcomes Research S.L.
- Article 77 implementation
- Advanced Outcomes Research S.L.
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Not authorised | 96 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Centro Médico Quirónsalud Alicante
Alergología, Calle Cruz de piedra, 4, Alicante
Hospital General Universitario De Castellon
Alergología, Avenida De Benicasim S/n, 12004, Castello De La Plana
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-14 | Spain | Not acceptable 2024-09-05
|
2024-09-09 |