Grass Immunotherapy for Rhinitis and Asthma (GIRA)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

LETI Pharma S.L.U.

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], Diseases [C] - Respiratory Tract Diseases [C08]

Decision date (initial)

2026-03-25

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

LETI Pharma S.L.U.

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

Double-Blind, Randomised,Controlled Phase
Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy for each concentration, evaluated by the combined symptom and medication score (0-6 collected through a mobile App) during the peak grass pollen compared with placebo after at least 8 injections of treatment.
Open-label Phase
Primary Efficacy: Assessment of the clinical efficacy of grasses allergen immunotherapy, evaluated by the change in the amount of allergen necessary to obtain a positive CPT (after the pollen season) compared to baseline.

Secondary objectives 2

1. Double-Blind, Randomised, Controlled Phase Secondary Efficacy: -Assessment of the clinical efficacy, quality of life, treatment satisfaction, use of resources and immunological parameters, of grasses allergen immunotherapy for each concentration, measured during whole grass pollen season compared between active (each concentration independently) and placebo groups; -Efficacy of AIT in the subset of participants with asthma, during the pollen peak and throughout the pollen season;
2. Open-label Phase Secondary Efficacy: -Assessment of clinical efficacy, quality of life, treatment satisfaction, use of resources and immunological parameters of grasses allergen immunotherapy, measured during whole grass pollen season; -Efficacy of AIT in the subset of participants with asthma, during the pollen peak and throughout the pollen season

Conditions and MedDRA coding

Allergic rhinoconjunctivitis with or without controlled asthma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 9

1. Participants aged ≥5 years of age at the time of signing consent or assent.
2. Participants suffering from moderate or severe allergic rhinoconjunctivitis (ARIA)
3. Asthmatic participants must be, in the Investigator’s judgement, with controlled disease according to Global Initiative on Asthma (GINA) guidelines
4. Participants/legal representatives who have understood and signed the informed consent or informed assent (see Section 10.1.4).
5. Participants or guardians need to have a mobile phone which can support the cSMS App and access to internet and/or mobile service.
6. Participants who are able to remain at their usual place of residence for the majority of the pollen season.
7. Participants are capable of complying with the study protocol.
8. Preexisting stable disease is allowed unless otherwise specified in the exclusion criteria in Section 5.2, as established by medical history and physical examination and as determined by the Investigator. Preexisting stable disease is defined as not requiring significant change in therapy or hospitalization for worsening disease during the 28 days before enrolment.
9. Agree to actively stay in contact with the trial site for the duration of the trial for the participant’s own safety

Exclusion criteria 23

1. Previous treatment with any type of AIT in the previous 5 years
2. Sensitisation to Alternaria alternata
3. Sensitisation to mites if clinically relevant
4. Sensitisation to epithelia if the participant lives or has frequent contact with animals.
5. Sensitisation to other co-seasonal allergens
6. Participants receiving treatment with biologics
7. Uncontrolled asthma at the time of immunotherapy administration, according to the GINA guidelines or unstable asthma
8. Female participants of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy. Female participants of childbearing potential may be enrolled in the study, if the participant: o has practiced adequate contraception for 1 month prior to study intervention administration, and o has a negative pregnancy test on the first day of study intervention administration, and o has agreed to continue adequate contraception during the entire study treatment period (see Section 10.4).
9. Lactating.
10. Any contraindication for treatment with SC allergen specific immunotherapy according to information of product use.
11. Participants who have required systemic corticosteroids in the 12 weeks prior to the inclusion (screening) in the trial.
12. Participants who have previously suffered a serious secondary reaction during the skin prick test (systemic reactions after SPT, which can be classified using World Allergy Organisation 2010 (WAO-2010) reactions and serious according to regulatory definition of serious adverse reaction).
13. Participants clinically unstable at the time of the inclusion (screening) in the trial (acute asthmatic exacerbation, respiratory infection, febrile fever, acute urticaria, etc); rescreening is permitted (see Section 5.4).
14. Any other clinical condition that, in the opinion of the Investigator, might pose additional risk to the participant due to participation in the study.
15. Participants with Investigator-determined chronic urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin tests will be performed, or a history of hereditary angioedema.
16. Participants with any condition that represents an absolute contraindication to the administration of adrenaline (heart disease, etc).
17. Participants undergoing immunosuppressive treatment (except topical immunosuppressants).
18. Participants with any other disease not associated with the moderate or severe rhinoconjunctivitis or asthma, but of potential severity and that could interfere with the treatment and follow-up (epilepsy, psychomotor deterioration, malformations, multi-operated, kidney diseases, etc).
19. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
20. Participants whose status prevents them from providing cooperation and/or who presents with severe psychiatric disorders.
21. Participants with known allergy to other vaccine components different from grass allergen extract.
22. Participants with chronic lower airway diseases other than asthma such as emphysema or bronchiectasis.
23. Direct relatives of the Investigator.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Double-Blind, Randomised, Controlled Phase: Mean cSMS (0-6) at peak grass pollen season comparing active and placebo groups after at least 8 injections of treatment. o Medication score: 0 no medication, 0.5 antihistamine eye drops, 1 oral antihistamine, 1.5 intranasal corticoid o Symptom score:Please refer to the protocol for further details

Secondary endpoints 1

1. Double-Blind, Randomised, Controlled Phase: Absolute values and changes from baseline (if applicable) during active pollen season comparing active and placebo groups after at least 8 injections: - Mean cSMS during the whole grass pollen season-Asthma symptoms and asthma medication score. Please refer to the Protocol for further details.Open-label Phase:Please refer to the Protocol for further details

Investigational products

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

Test 2

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

LETI Pharma S.L.U.

Sponsor organisation

LETI Pharma S.L.U.

Address

Calle Del Sol 5, Zona Industrial Tres Cantos Zona Industrial Tres Cantos

City

Tres Cantos

Postcode

28760

Country

Spain

Scientific contact point

Organisation

LETI Pharma S.L.U.

Contact name

Mónica Ruiz García

Public contact point

Organisation

LETI Pharma S.L.U.

Contact name

LETI Pharma S.L.U.

Third parties 6

Locations

2 EU/EEA countries · 32 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 46 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