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Intralymphatic Allergen Immunotherapy (ILIT) in grass pollen allergy: a randomized controlled trial
EU CTIS ID: 2025-522376-82-00
What this study is testing
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.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- • Patients aged 18 or older
- 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)
- • 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).
- • Provision of signed and dated informed consent form approved from IRB/IEC
You likely can't join if
- • Significant year-round allergy symptoms or minor year-round symptoms without worsening during grass pollen seasons
- • 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).
- • Clinically relevant allergy to Parietaria pollen
- • Pregnant or nursing
- • Significant cardiovascular, hepatic, renal, autoimmune, hematological, psychiatric or active infectious disease
- • Pulmonary disease, other than seasonal asthma but including perennial asthma, with perennial use of inhaled corticosteroids
See the full eligibility criteria
- • Patients aged 18 or older
- 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)
- • 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).
- • Provision of signed and dated informed consent form approved from IRB/IEC
- • Significant year-round allergy symptoms or minor year-round symptoms without worsening during grass pollen seasons
- • 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).
- • Clinically relevant allergy to Parietaria pollen
- • Pregnant or nursing
- • Significant cardiovascular, hepatic, renal, autoimmune, hematological, psychiatric or active infectious disease
- • Pulmonary disease, other than seasonal asthma but including perennial asthma, with perennial use of inhaled corticosteroids
- • Previous grass pollen AIT
- • No readily accessible inguinal lymph nodes
- • Chronic therapy with corticosteroids (≥10 mg/day of prednisone or equivalent for >2 weeks)
- • Immunosuppressive drugs
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.