Lepidoglyphus destructor extract. Determination of in vivo allergenic potency in histamine equivalent prick testing units (HEP).

Overview

Sponsor-declared trial summary

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

23 Oct 2024 → 13 Feb 2026

Decision date (initial)

2024-08-14

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: Dose response, Diagnosis

Assessment of the concentration of Lepidoglyphus destructor extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution.

Conditions and MedDRA coding

Allergy to Lepidoglyphus destructor

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Lepidoglyphus destructor.
2. A positive prick-test (mean wheal diameter ≥ 3 mm) with an extract of the same allergen and/or presence of specific IgE to the allergen.
3. The mean area of the wheal obtained with 10 mg/mL Histamine dihydrochloride should be ≥ 7 mm².
4. Age between 18 and 64 years.
5. Must be able to provide informed consent.
6. * Women of childbearing age (i.e following menarche and until postmenopause, defined as no menses for 12 months without an alternative medical cause, or non-subject to permanent sterilization methods, such as hysterectomy, bilateral salpingectomy and bilateral oophorectomy) must present a negative urine pregnancy test at the time of enrollment in the trial, as well as a confirmed menstrual period.
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, intrauterine hormone-releasing system, male condom, diaphragm used with spermicide, bilateral tubal occlusion, vasectomized partner or sexual abstinence.

Exclusion criteria 11

1. Subjects outside the age range.
2. Subjects who have previously received immunotherapy within the last 5 years for the treatment of asthma or allergic rhinoconjunctivitis induced by allergens that may interfere with Lepidoglyphus destructor extracts.
3. Subjects with significant symptoms of rhinoconjunctivitis and/or bronchial asthma in whom discontinuation of systemic antihistamine treatment is contraindicated.
4. Subjects who have previously exhibited a severe adverse reaction during diagnostic skin prick tests.
5. Subjects on treatment with ß-blockers.
6. Clinically unstable subjects (acute asthma, febrile, etc.).
7. 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).
8. Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.
9. States in which the subject is unable to offer cooperation and severe psychiatric disorders.
10. Pregnant or potentially pregnant women and breastfeeding women.
11. Subjects with known phenol allergy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To assess the concentration of Lepidoglyphus destructor extract that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution.

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

Miguel Casanovas

Public contact point

Organisation

Inmunotek S.L.

Contact name

Miguel Casanovas

Locations

1 EU/EEA country · 1 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

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 8 files

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

Application history

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