Intralymphatic Allergen Immunotherapy (ILIT) in grass pollen allergy: a randomized controlled trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

University Of Foggia

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune System Phenomena [G13], Diseases [C] - Respiratory Tract Diseases [C08], Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2025-10-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

MIUR_PRIN: PROGETTI DI RICERCA DI RILEVANTE INTERESSE NAZIONALE – Bando 2022 Prot. 20228YERZP

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

Efficacy and safety of ILIT, in adolescents and adults with allergic rhino-conjunctivitis, with or without asthma, due to grass pollen, using currently available commercial allergen extracts (for ILIT administration), will be assessed and will represent the primary outcomes of this RCT.

Secondary objectives 1

1. Some of the biological effects of ILIT in the study population will be investigated. Since it has been known for many years that AIT modifies the IgE-mediated immune response to allergens, the effects on mast cell-bound specific IgE as well as on circulating unbound specific IgE will be assessed. Total IgE levels will also be measured. Moreover, serum allergen specific IgG4 levels will be assayed, as a predictor of clinical response to treatment.

Conditions and MedDRA coding

allergic diseases (allergic rhinosinusitis, allergic asthma, allergy to Hymenoptera venoms)

Study design 2 periods

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. • Patients aged 18 or older
2. Patients affected by moderate to severe allergic rhino-conjunctivitis (according to ARIA definition) diagnosed through a positive skin prick test - wheal, 3 mm larger than negative control-, and circulating specific IgE (minimum 0.5 kU/l) to grass pollen)
3. • History of moderate-to-severe allergic rhinitis during the previous pollen season, documented at screening by a Symptom Score ≥ 7, or, if a previous Symptom Score is unavailable, by a self-reported retrospective visual analogue scale (VAS) rating of nasal and/or ocular symptoms ≥ 4/10 cm (0 = no symptoms; 10 = worst imaginable symptoms), obtained using a standardized questionnaire (VAS question: ‘Considering the period of worst symptoms during last pollen season, how severe were your nasal and/or ocular symptoms?’) and referring to the two-week period of peak symptom severity during the previous season (April–June).
4. • Provision of signed and dated informed consent form approved from IRB/IEC

Exclusion criteria 10

1. • Significant year-round allergy symptoms or minor year-round symptoms without worsening during grass pollen seasons
2. • Clinically relevant allergy to Parietaria pollen
3. • Pregnant or nursing
4. • Significant cardiovascular, hepatic, renal, autoimmune, hematological, psychiatric or active infectious disease
5. • Pulmonary disease, other than seasonal asthma but including perennial asthma, with perennial use of inhaled corticosteroids
6. • Previous grass pollen AIT
7. • No readily accessible inguinal lymph nodes
8. • Chronic therapy with corticosteroids (≥10 mg/day of prednisone or equivalent for >2 weeks)
9. • Immunosuppressive drugs
10. • Contraindications to the use of the Investigational Medicinal Product (i.e. hypersensitivity to any of the excipients of the standardized allergen extract modified with glutaraldehyde (allergoid) adsorbed onto L-tyrosine for delayed subcutaneous specific immunotherapy, severe chronic and inflammatory diseases, multiple sclerosis, autoimmune diseases, immunodeficiencies, active pulmonary and ocular tuberculosis, severe psychiatric disorders, cardiovascular insufficiency, chronic heart and/or lung diseases, malignant diseases, current concomitant treatment with beta-blockers or ACE inhibitors, febrile infections of the respiratory tract), or of the placebo (i.e. hypersensitivity to phenol or to any of the other excipients).

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 3

1. 1. Symptom scores (SS) (primary endpoint), ranging from 0 to 18 points, with 3 nasal and 3 ocular symptoms (runny nose, blocked nose, sneezing, red eyes, itchy eyes and watery eyes), each of which scored from 0 (no symptoms) to 3 (severe symptoms);
2. 2. Medication scores (MS), taking into account the exact number of anti-histamine tablets, nasal corticosteroid puffs, eye drops
3. 3. Rhino-conjunctivitis Quality of Life Questionnaire (RQLQ)

Investigational products

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

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

University Of Foggia

Sponsor organisation

University Of Foggia

Address

Via Antonio Gramsci 89/91

City

Foggia

Postcode

71122

Country

Italy

Scientific contact point

Organisation

University Of Foggia

Contact name

Maria Filomena Caiaffa

Public contact point

Organisation

University Of Foggia

Contact name

Maria Filomena Caiaffa

Third parties 1

Locations

1 EU/EEA country · 2 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 15 files

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

Application history

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