Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
36
Countries
1
Sites
1
Allergies
Biological standardization of the allergenic extract of Lepidoglyphus destructor
Key facts
- Sponsor
- Asac Pharmaceutical Inmunology S.A., Advanced Outcomes Research S.L.
- 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)
- 2025-08-13
- 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 Lepidoglyphus destructor
Conditions and MedDRA coding
Allergies
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 5
- Patient residing in a geographic area where Lepidoglyphus destructor is prevalent
- Age between 18 and 50 years, regardless of gender.
- Patient diagnosed with IgE-mediated allergy to Lepidoglyphus destructor 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.
- Wheal diameter ≥ 4 mm induced by a solution of histamine dihydrochloride at 10 mg/ml (positive control).
- 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
- 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.
- 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.
- 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.
- 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.
- Patient's inability to understand the objective/purpose of the study.
- Patient's inability/refusal to sign the informed consent for participation in the study
- Hypersensivity to any of the excipients in the investigational product
- 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 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 3
Diagnóstico prick Lepidoglyphus destructor
PRD11854147 · Product
- Active substance
- Lepidoglyphus Destructor
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- INTRAEPIDERMAL 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 Lepidoglyphus destructor
PRD11854400 · Product
- Active substance
- Lepidoglyphus Destructor
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- INTRAEPIDERMAL 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 Lepidoglyphus destructor
PRD11854417 · Product
- Active substance
- Lepidoglyphus Destructor
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- INTRAEPIDERMAL 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
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
- Advanced Outcomes Research S.L.
- Contact name
- Dra. Carmen Santos
Public contact point
- Organisation
- Advanced Outcomes Research S.L.
- Contact name
- Dra. Carmen Santos
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
Sponsor responsibilities
- Article 77 compliance
- Asac Pharmaceutical Inmunology S.A.
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 36 | 1 |
| Rest of world | — | 0 | — |
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.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2025-520753-37-00 | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitmen arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults_public | 2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES 2025-520753-37-00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-12 | Spain | Acceptable 2025-07-30
|
2025-08-13 |