Phleum pratense and Dactylis glomerata allergen extracts. Determination of the in vivo histamine equivalent prick test units.

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

26 Nov 2024 → 7 Feb 2025

Decision date (initial)

2024-11-06

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, Dose response

The primary objective is to assess the concentration of each allergen extract (Phleum pratense and Dactylis glomerata) that induces a wheal of size equivalent to that produced by a 10 mg/mL histamine dihydrochloride solution.

Secondary objectives 1

1. The secondary objective is to assess the safety and tolerability of each allergen extract (Phleum pratense and Dactylis glomerata)

Conditions and MedDRA coding

Allergy to Phleum pratense and Dactylis glomerata.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Subjects who have signed and dated informed consent form
2. Female or male aged 18 to 64 years, both included
3. Subjects must reside in a geographical area where allergic problems caused by Phleum pratense and Dactylis glomerata are relevant
4. Positive medical history of inhalant allergy (rhinitis and/or rhinoconjunctivitis and/or asthma) to Phleum pratense and Dactylis glomerata
5. A positive prick-test (mean wheal diameter ≥ 3 mm) with extracts of the same allergens and/or presence of specific IgE against complete extract or any molecular component to the allergenic sources.
6. The area of the wheal obtained with 10 mg/mL histamine dihydrochloride should be ≥ 7 mm², which corresponds to a mean wheal diameter ≥ 3 mm.
7. The area of the wheal obtained with negative control should be < 7 mm², which corresponds to a mean wheal diameter < 3 mm.
8. 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.
9. 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 13

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 the extracts of Phleum pratense and Dactylis glomerata.
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. Use of drugs that could interfere with skin prick test reactions (e.g., antihistamines)
7. Clinically unstable subjects (acute asthma, febrile, etc.).
8. 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)
9. Subjects with active herpes simplex viral infection, or herpes varicella zoster in the area where the prick test is performed.
10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.)
11. States in which the subject is unable to offer cooperation and severe psychiatric disorders.
12. Pregnant or potentially pregnant women and breastfeeding women.
13. Subjects with known phenol allergy.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The primary efficacy endpoint involves measuring the area (mm2) of the induced wheal on the skin upon applying each of the 3 concentrations of each allergenic extract (Phleum pratense and Dactylis glomerata), as well as those induced by positive (histamine) and negative controls, through the prick test.

Secondary endpoints 2

1. Overall rate, seriousness, and ratio of any adverse event (AE) by administration and by subject.
2. Assessment of administration site reactions, systemic reactions and any medication administered for the treatment of adverse reaction (AR).

Investigational products

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

Test 2

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

Raquel Caballero

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

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