Clinical trial to assess the efficacy and safety of a vaccine for dust mite allergy

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]

Trial duration

5 Aug 2020 → 27 Apr 2026

Decision date (initial)

2024-08-16

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

INMUNOTEK, S.L.

External identifiers

EU CT number

2024-514090-21-00

EudraCT number

2018-004262-34

ClinicalTrials.gov

NCT04435990

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy, Efficacy

The main objective of this trial is to evaluate the clinical efficacy of subcutaneously administered polymerised allergen extracts compared to placebo in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis according to the ARIA classification with or without mild-moderate controlled intermittent or persistent asthma as defined by GEMA 5.0.

Secondary objectives 1

1. To assess the safety and efficacy of the polymerised extracts under the above conditions by comparing the active and placebo groups both at the beginning and at the end of the study on all secondary variables.

Conditions and MedDRA coding

Aetiological treatment of moderate - severe intermittent or persistent allergic rhinitis/rhinoconjunctivitis with or without controlled mild - moderate intermittent or persistent allergic asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 12

1. Subjects who have signed the informed consent form.
2. Subjects of both sexes aged between 12 and 65 years old.
3. Subjects with a confirmed clinical history of inhalant allergy (intermittent or persistent moderate-severe rhinitis and/or rhinoconjunctivitis according to the ARIA classification with or without controlled intermittent or persistent mild-moderate asthma according to the GEMA 5.0 definition) caused by allergy to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae.
4. Subjects who have had a prick test result ≥ 5 mm in diameter greater for Dermatophagoides pteronyssinus and/or for Dermatophagoides farinae. Positive and negative control test results must be consistent.
5. Subjects with a specific IgE value > 3.5 KU/L (ImmunoCAP® or Immulite) for complete extract of Dermatophagoides pteronyssinus and/or for Dermatophagoides farinae or for some of the molecular components of these allergenic sources
6. Subjects shall preferably be monosensitised to the study allergens. In the case of subjects sensitised to other aeroallergens, only those with the following characteristics (results valid 12 months prior to signing the informed consent) may be included in the study: (a) Subjects with positive skin test to Blomia tropicalis and Lepidoglyphus destructor, whose maximum specific IgE values are 3.5 KU/L. b) Subjects with negative skin test. Subjects with positive skin tests for epithelia may be included in the study, provided that they have occasional exposure and symptomatology. c) Subjects with positive skin tests for pollens, whose specific IgE values do not exceed or equal the values for the study allergens and who, in addition, do not present exacerbations in the pollen season. The maximum value of specific IgE for these allergens is 17.5 KU/L.
7. Subjects with negative skin test for fungus.
8. Women of childbearing age (since menarche) should submit a negative urine pregnancy test at the time of entry into the trial, prior to administration of the first dose of investigational medicinal product.
9. Women of childbearing potential participating in the trial should agree to use an adequate method of contraception, defined as any act, device, or medication to prevent conception or a viable pregnancy, during the trial if sexually active.
10. Subjects diagnosed with asthma according to GEMA 5.0.
11. Subjects able to comply with the dosing regimen.
12. Subjects owning a smartphone to record symtom and medication.

Exclusion criteria 15

1. Subjects who have received previous immunotherapy in the previous 5 years to epithelia, fungi and mites.
2. Subjects in whom immunotherapy may be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.
3. Subjects with severe or uncontrolled persistent asthma, with an FEV1 < 70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial.
4. Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick tests.
5. Subjects on ß-blocker treatment.
6. Subjects who are clinically unstable at the time of inclusion in the trial (acute asthmatic exacerbation, respiratory infection, febrile process, acute urticaria, etc).
7. Subjects with active chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin testing will be performed, or a history of hereditary angioedema.
8. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
9. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but potentially serious and which may interfere with treatment and follow-up (epilepsy, psychomotor alteration, uncontrolled diabetes, malformations, multioperative, nephropathy, etc.).
10. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
11. Subjects whose condition prevents them from cooperating or who present severe psychiatric disorders.
12. Subjects with known allergy to components of the investigational medicinal product other than the allergen.
13. Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.
14. Subjects who are immediate family relatives of researchers.
15. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. To evaluate the efficacy of allergen extracts in subjects with moderate-severe intermittent or persistent rhinitis/rhinoconjunctivitis with or without controlled mild to moderate intermittent or persistent asthma sensitised to Dermatophagoides pteronyssinus and/or Dermatophagoides farinae, aged 12-65 years, by assessing the combined symptom score and medication intake, between baseline and end of the trial.

Secondary endpoints 15

1. Rhinitis/rhinoconjunctivitis symptom score (RSS)
2. Rhinitis/rhinoconjunctivitis medication score (RMS)
3. Asthma combined symptom and medication score (ACSMS)
4. Asthma symptom score (ASS)
5. Asthma Medication Score (AMS)
6. Asthma and Rhinitis/Rhinoconjunctivitis Symptom Score (ARSS)
7. Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS)
8. Combined symptom and medication score for asthma and rhinitis/rhinoconjunctivitis (ARCSMS)
9. Symptom-free days and medication-free days for rhinitis/rhinoconjunctivitis and for asthma
10. Time since first onset of asthma exacerbation, number, severity, and duration of asthma exacerbations
11. Quality of life using the ESPRINT-15 questionnaire in rhinitis and asthma monitoring using the asthma symptom control questionnaire (GINA)
12. Visual Analogue Scale (VAS)
13. Serum immunological parameters (total IgE, specific IgE and specific IgG4)
14. Consumption of health resources
15. Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse events (AEs) per administration and per subject and assessment of administration site reactions, systemic reactions and any concomitant medication administered for the treatment of AEs)

Investigational products

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

Test 2

Placebo 1

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

Medical Department

Public contact point

Organisation

Inmunotek S.L.

Contact name

Medical Department

Locations

1 EU/EEA country · 27 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

Documents 7 files

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

Application history

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