Clinical trial developed at various hospitals where each patient randomly receive in parallel groups either placebo or treatment. Nor patients or investigators will know what the patient it's being given. This clinical trial evaluates efficacy and safety of the immunotherapy with allergen "Cup a 1" (major protein in Cupressus arizónica) in patients with allergic rhinoconjunctivitis with or without asthma sensitized to Cupressaceae pollen

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

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

9 Jun 2022 → 7 May 2025

Decision date (initial)

2024-12-19

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

External identifiers

EU CT number

2024-519527-14-00

EudraCT number

2022-000615-31

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety

Assessment of efficacy of specific immunotherapy with the purified and isolated protein Cup a 1 administered subcutaneously in patients sensitized to the allergen under study

Secondary objectives 8

1. Analysis of additional efficacy parameters to the combined index of symptom frequency and severity score together with rescue medication consumption score
2. Evaluate the variation of follow-up skin tests with Cupressaceae and Cup a 1 extracts
3. Control of asthma and allergic rhinitis assessment, using the ACT and the modified ARIA scale
4. Patient's health status assessment using the VAS scale
5. Quality of life evaluation according to rhinitis (ESPRINT-15)
6. Evaluate the immunological markers related to efficacy: IL-10, IL-13, INF-ƴ, IgG4, total IgE and specific IgE against Cupressus arizonica and Cup a 1.
7. Evaluate the degree of tolerance against conjunctival provocation with Cupressaceae extract
8. Evaluation of the safety of the treatment, through the registry of AA and AAG

Conditions and MedDRA coding

Allergic rhinoconjunctivitis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Male or female from 12 to 65 years of age included
2. Obtaining informed consent to participate in the study, as well as legal guardians or legal representatives, if it is a minor
3. Moderate or severe allergic rhinitis or rhinoconjunctivitis, according to the modified ARIA classification, with or without asthma controlled by demonstrated sensitization to Cupresaceae
4. Cupressus or Cup a 1 IgE levels greater or equal than 2 kU/l (classes 3 to 6)
5. Positive skin prick test (≥3 mm in diameter) for Diater extract of Cupressaceae arizónica and Cup a 1, carried out in V0
6. Clinically relevant symptoms against cupresaceae.
7. Willingness to comply with all protocol requirements and availability for follow-up throughout the duration of the trial
8. Negative urine pregnancy test for women of childbearing potential (fertile from menarche to postmenopause, unless sterilized due to hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) and willing to use effective contraception from 14 days before the first administration until 30 days after the last investigational product administration.

Exclusion criteria 15

1. Clinically relevant polysensitization: epithelia if they coexist with animals, mites, fungi and pollens at the investigator's discretion
2. Nasal or paranasal recent or scheduled pathology or surgery that may interfere with the trial, such as polyposis, at the investigator's discretion
3. Uncontrolled serious systemic diseases, such as autoimmune, cardiovascular, hyperthyroidism, liver disease or kidney failure, malignant tumours or chronic infection
4. Uncontrolled asthma despite optimal pharmacological treatment
5. Having received immunotherapy to cupresaceae or phylogenetically related allergens in the 5 years prior to the start of the trial
6. Being receiving immunotherapy against other different allergens than Cupressaceae concomitantly during the trial
7. Adrenaline use contraindication
8. Active tuberculosis
9. Severe atopic eczema
10. Dermographism, pathologies or skin alterations that interfere with the evaluation of skin tests
11. Psychiatric disorder that prevents adequate compliance with the immunotherapy program
12. Pregnant or lactating woman
13. Simultaneous participation in another clinical trial
14. Any disease that interferes with the absorption or elimination of the investigational products
15. Chronic abuse of alcohol or any other type of substance that, in the opinion of the investigator, may interfere with the trial

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The efficacy of the treatment will be evaluated based on the symptom frequency and severity score together with the Combined Symptom and Medication Score (CSMS), which will be obtained through a questionnaire completed by the patient during 2 successive pollen seasons

Secondary endpoints 12

1. Symptom frequency and severity score. Results are compared between treatment arms and between pollen seasons
2. Score for Rescue medication use
3. Symptom-free days
4. Medication-free days
5. Extra visits and/or emergencies during the period of the clinical trial related to the pathology under study
6. Skin follow-up skin test with Cupressaceae extract and Cup a 1
7. Asthma and allergic rhinitis control assessed by ACT and modified ARIA
8. Visual Analog Scale (VAS) for the state of health performed by the patient
9. ESPRINT-15 questionnaire evaluation
10. Evaluation of immunological markers: IL-10, IL-13, INF-ƴ, specific IgE and specific IgG4 against Cupressus arizonica and Cup a 1
11. Conjunctival provocation against cupresaceae
12. Frequency of adverse events (AEs), serious AAs (SAEs) and ADRs, particularly systemic events according to the World Allergy Organization (WAO) 2010 classification

Investigational products

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

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Sponsor organisation

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Address

Avenida De Gregorio Peces Barba 2

City

Leganes

Postcode

28919

Country

Spain

Scientific contact point

Organisation

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Contact name

Aída Gómez Cardeñosa

Public contact point

Organisation

Diater Laboratorio De Diagnostico Y Aplicaciones Terapeuticas S.A.

Contact name

Aída Gómez Cardeñosa

Locations

1 EU/EEA country · 19 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 16 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