Allergen extract of Lepidoglyphus destructor. Study of the sensitivity and specificity of the diagnostic preparation in prick tests

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmunotek S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-06-01

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Inmunotek S.L.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

The main objective is to determine the sensitivity and specificity of the different concentrations of the allergenic extract L. destructor, as well as
other parameters (efficiency, positive and negative predictive value, and probability ratio of a positive and negative test) that will be used for the
prick test.The results will provide the data necessary to choose the optimal concentration of each allergen extract to be used for each preparation.

Secondary objectives 2

1. To evaluate the safety and tolerability of the L. destructor allergen extract.
2. To determine the allergenic profile (ALEX technique) of each participant.

Conditions and MedDRA coding

Allergy to Lepidoglyphus destructor

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Participants who have signed and dated the informed consent form.
2. Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to other perennial allergens or pollens, but not to L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
3. Participants aged between 12 and 70 years, both sexes included
4. Positive prick test with the positive control (histamine dihydrochloride at 10 mg/mL). The mean wheal diameter induced by this control must be ≥ 3 mm.
5. Negative prick test with the negative control. The mean wheal diameter induced by this control must be < 3 mm.
6. Women of childbearing age (from menarche to postmenopause, defined as the absence of menstruation for 12 months without an alternative medical cause, or not undergoing permanent sterilization methods, such as hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) must present a negative urine pregnancy test and confirmation of their last menstrual period at the time of enrollment in the trial.
7. Women of childbearing age must commit to using a highly effective and adequate contraception method during the trial and up to 72 hours after the end of treatment with the investigational medicinal product. Such methods include combined (estrogen and progestogen containing) hormonal; contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized partner or sexual abstinence.
8. Positive clinical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor).
9. Positive prick test (mean wheal diameter ≥ 3 mm) to a standardized extract of L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor)).
10. Specific IgE with a value > 0.35 kU/L to whole extract of L. destructor (Inclusion criteria for CH+ participants (true positives for L. destructor)).
11. Negative prick test (mean wheal diameter < 3 mm) to a standardized extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).
12. Specific IgE with a value < 0.35 kU/L to an extract of L. destructor (Inclusion criteria for CH- participants (true negatives for L. destructor)).

Exclusion criteria 12

1. Participants 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).
2. Participants with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
3. Participants who have previously exhibited a severe adverse reaction during diagnostic skin prick testing.
4. Participants with active viral infection by herpes simplex or herpes zoster in the area where the prick test is performed.
5. Participants who are clinically unstable at the time of inclusion in the trial (acute asthma, fever, etc.).
6. Participants with any severe psychiatric disorder.
7. Participants on treatment with beta-blockers.
8. Use of drugs that may interfere with the skin response (e.g., antihistamines) (see Section 8.6.1).
9. Participants with any condition in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
10. Participants with a known allergy to phenol.
11. Pregnant or breastfeeding women.
12. Participants who have received previous immunotherapy in the last 5 years or are being treated with an allergen extract of L. destructor (Exclusion criteria for HC+ participants (true positives for L. destructor)).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Area (mm²) of wheals induced by different concentrations of the L. destructor allergen extract, as well as the areas of wheals induced by the positive control and negative control, using the prick test

Secondary endpoints 2

1. Safety parameters: • Overall rate, seriousness, and ratio of any adverse event (AE) by administration and by subject • Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of adverse reaction (AR)
2. Allergen profiling (ALEX technique)

Investigational products

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

Test 1

Auxiliary 2

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

Raquel Caballero Valentín

Public contact point

Organisation

Inmunotek S.L.

Contact name

Raquel Caballero Valentín

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

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

Documents 12 files

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

Application history

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