Overview
Sponsor-declared trial summary
Allergy to Quercus ilex and Quercus robur
The main objective is to evaluate the concentration of allergenic extract from Quercus ilex and Quercus robur that causes a papule of a size equivalent to that produced by a solution of histamine dihydrochlorohydrochloride at 10 mg/mL.
Key facts
- Sponsor
- Inmunotek S.L.
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20]
- Trial duration
- 26 Jan 2023 → 28 Jan 2025
- Decision date (initial)
- 2024-10-03
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- INMUNOTEK, S.L.
External identifiers
- EU CT number
- 2024-515189-14-00
- EudraCT number
- 2020-005388-30
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Diagnosis
The main objective is to evaluate the concentration of allergenic extract from Quercus ilex and Quercus robur that causes a papule of a size equivalent to that produced by a solution of histamine dihydrochlorohydrochloride at 10 mg/mL.
Conditions and MedDRA coding
Allergy to Quercus ilex and Quercus robur
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | PT | 10053462 | Allergy test | 100000004848 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Subjects with a positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Quercus ilex and Quercus robur.
- Subjects with a positive n prick-test (mean papule diameter >= 3 mm) with an extract of the same allergen and/or presence of specific IgE to that allergen.
- The mean papule area obtained with Histamine dichlorohydrate at 10 mg/mL should be >= 7 mm2.
- Age: between 18 and 64 years.
- Both sexes.
- Must be able to give informed consent.
- Women of childbearing age (from menarche) must present a negative urine pregnancy test at the time of entry into the trial.
Exclusion criteria 12
- Subjects outside the age range.
- Subjects who have previously received immunotherapy within the last 5 years for the treatment of allergic asthma or allergen-induced allergic rhinoconjunctivitis that may interfere with Quercus ilex and Quercus robur extract.
- Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
- Subjects who have previously had a severe secondary reaction during diagnostic skin prick tests.
- Subjects under treatment with ß-blockers.
- Subjects who are clinically unstable (acute asthma, febrile, etc.).
- Subjects with active urticaria lesions, severe active dermographism, severe atopic dermatitis, sunburn, eczema, psoriasis lesions in the area where the prick test is performed (risk of false positives).
- Subjects with active herpes simplex virus infection or varicella zoster herpes in the area where the prick test is performed.
- Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
- Conditions in which the subject is unable to cooperate and severe psychiatric disorders.
- Pregnant women or women at risk of pregnancy and breastfeeding women.
- Subjects with known allergy to phenol.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary and single variable is the size of the induced skin papule on application of each of the concentrations of the allergenic extracts and of the positive (histamine) and negative controls, using the prick test.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Prick test of Quercus robur allergen extract
PRD11535540 · Product
- Active substance
- Quercus Robur Pollen Extract
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 Gtt drop(s)
- Max total dose
- 6 nl nanolitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA05 — TREE POLLEN
- MA holder
- INMUNOTEK S.L.
- Paediatric formulation
- No
- Orphan designation
- No
Prick test of Quercus ilex allergen extract
PRD11535505 · Product
- Active substance
- Quercus Ilex Allergen Extract
- Substance synonyms
- T525
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 Gtt drop(s)
- Max total dose
- 6 nl nanolitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V01AA05 — TREE POLLEN
- MA holder
- INMUNOTEK S.L.
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
Skin Prick Test Negative control
PRD11276451 · Product
- Active substance
- Sodium Chloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 Gtt drop(s)
- Max total dose
- 2 nl nanolitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- V04CL — TESTS FOR ALLERGIC DISEASES
- MA holder
- INMUNOTEK S.L.
- Paediatric formulation
- No
- Orphan designation
- No
Skin Prick Test Positive control
PRD11269985 · Product
- Active substance
- Histamine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR SKIN-PRICK TEST
- Route of administration
- CUTANEOUS USE
- Max daily dose
- 2 Gtt drop(s)
- Max total dose
- 2 nl nanolitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- L03AX14 — -
- MA holder
- INMUNOTEK S.L.
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Inmunotek S.L.
- Sponsor organisation
- Inmunotek S.L.
- Address
- Calle Punto Mobi 5
- City
- Alcala De Henares
- Postcode
- 28805
- Country
- Spain
Scientific contact point
- Organisation
- Inmunotek S.L.
- Contact name
- Miguel Casanovas
Public contact point
- Organisation
- Inmunotek S.L.
- Contact name
- Raquel Caballero
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ended | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Spain | 2023-01-26 | 2025-01-28 | 2023-02-08 | 2024-11-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Summary of results Art. 37(4) CTR
| Title | Submission date | Status | Type |
|---|---|---|---|
| Quercus ilex and Quercus robur allergen extracts. Determination of the in vivo allergenic potency in SUM-107033
|
2025-12-01T12:49:29 | Submitted | Summary of Results |
Layperson summary Annex V
| Title | Submission date | Status | Type |
|---|---|---|---|
| Extracto alergénico de Quercus ilex y Quercus robur. Determinación de la potencia alergénica in vivo | 2025-12-01T12:49:48 | Submitted | Laypersons Summary of Results |
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Laypersons summary of results (for publication) | Clinical Study Report_Layperson summary_SP_20250912 | NA |
| Protocol (for publication) | D1_Protocol ES_2024-515189-14-00_Redacted | 03.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF general redacted | 02 |
| Summary of results (for publication) | Clinical Study Report_Summary of results_20251106 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis ES_2024-515189-14-00_Redacted | 03.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_EN_2024-515189-14-00_Redacted | 03.1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-06 | Spain | Acceptable 2024-10-03
|
2024-10-03 |