Clinical trial to asses the efficacy and safety of a vaccine for grasses and cupressaceae allergy

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Inmunotek S.L.

Participant type

Pediatric, Patients

Age range

0-17 years, 18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

11 May 2021 → ongoing

Decision date (initial)

2024-08-14

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514524-16-00

EudraCT number

2019-002865-37

ClinicalTrials.gov

NCT04898283

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The main objective of this clinical trial is to evaluate the clinical efficacy of subcutaneously administered polymerized allergen extracts compared to placebo in subjects with rhinitis/rhinoconjunctivitis according to the ARIA classification, with or without controlled intermittent or persistent (mild-moderate) asthma, as defined by GEMA 5.0 during pollen season and pollen peak of grasses and cupressaceae.

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 intermitent 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 11

1. 1. Subject who has signed the informed consent form.
2. 2. Subjects of both sexes aged between 12 and 65 years.
3. 3. Subjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.
4. 4. Subjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract. In addition, the wheal major diameter must be greater than or equal to that of the histamine.
5. 5. Specific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and cupressaceae or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L.
6. 6. Women of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.
7. 7. Women of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligations), barrier methods, or the use of oral contraceptives.
8. 8. Subjects able to comply with the dosing regimen.
9. 9. Subjects with a smartphone to record symptoms and medication consumption.
10. 10. Subjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.
11. 11. Subjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.

Exclusion criteria 17

1. 1. Subjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.
2. 2. Subjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae.
3. 3. Subjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.
4. 4. 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.
5. 5. 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. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated.
6. 6. Subjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test.
7. 7. Subjects on treatment with ß-blockers.
8. 8. Clinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.).
9. 9. Subjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.
10. 10. Subjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).
11. 11. Subjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathies).
12. 12. Subjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.
13. 13. Subject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.
14. 14. Subjects with known allergy to components of the investigational medicinal product other than the allergen.
15. 15. Subjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.
16. 16. Subjects who are immediate family members of investigators.
17. 17. Pregnant or breastfeeding women.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).

Secondary endpoints 17

1. Symptom free days in rhinitis/rhinoconjunctivitis and asthma
2. Medication-free days in rhinitis/rhinoconjunctivitis and asthma
3. Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae.
4. Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae.
5. Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae.
6. Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae.
7. Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae.
8. Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae.
9. Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae
10. Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae.
11. Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity.
12. Visual Analogue Scale (VAS)
13. Immunological parameters (total IgE, specific IgE and specific IgG4).
14. Asthma Control Questionnaire (ACQ-6).
15. Rhinitis Follow-up Questionnaire (ESPRINT-15).
16. Register of consumption of health resources.
17. Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)

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

Miguel Casanovas

Public contact point

Organisation

Inmunotek S.L.

Contact name

Raquel Caballero Valentín

Locations

1 EU/EEA country · 23 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

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