glutaraldehyde-modified L-tyrosine adsorbed grass pollen extract (Phleum pratense, Poa pratensis, Cynodon dactylon) for Allergic rhinoconjunctivitis|Grass pollen allergy|Allergic asthma

Inclusion criteria

• {"criterion_text":"- Patients aged 18 or older\n- 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)\n- 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).\n- Provision of signed and dated informed consent form approved from IRB/IEC"}

Exclusion criteria

• {"criterion_text":"- Significant year-round allergy symptoms or minor year-round symptoms without worsening during grass pollen seasons\n- 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).\n- Clinically relevant allergy to Parietaria pollen\n- Pregnant or nursing\n- Significant cardiovascular, hepatic, renal, autoimmune, hematological, psychiatric or active infectious disease\n- Pulmonary disease, other than seasonal asthma but including perennial asthma, with perennial use of inhaled corticosteroids\n- Previous grass pollen AIT\n- No readily accessible inguinal lymph nodes\n- Chronic therapy with corticosteroids (≥10 mg/day of prednisone or equivalent for >2 weeks)\n- Immunosuppressive drugs"}

Primary endpoints

• {"endpoint_text":"- 1.\tSymptom 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);","definition_or_measurement_approach":"Symptom score (SS) ranging 0–18 composed of 3 nasal and 3 ocular symptoms each scored 0–3."}
• {"endpoint_text":"- 2.\tMedication scores (MS), taking into account the exact number of anti-histamine tablets, nasal corticosteroid puffs, eye drops","definition_or_measurement_approach":"Medication score (MS) based on the exact count of antihistamine tablets, nasal corticosteroid puffs and eye drops used."}
• {"endpoint_text":"- 3.\tRhino-conjunctivitis Quality of Life Questionnaire (RQLQ)","definition_or_measurement_approach":"Patient-reported outcome measured using the RQLQ instrument."}

Italy

Earliest CTIS Part Ii Submission Date

16-10-2025

Latest Decision Or Authorization Date

11-12-2025

Processing Time Days

56

Number Of Sites

2

Number Of Participants

70

Primary sponsor

Full Name

University Of Foggia

Organisation Type

Educational Institution

Country Of Registered Address

Italy

Contract research organisations

Name

Center For Outcomes Research And Clinical Epidemiology S.r.l.

Responsibilities

sponsorDuties codes: 1,10,11,12,5,6; contact email core@coresearch.it, phone 0859047114

Third parties

• {"country":"Italy","full_name":"Center For Outcomes Research And Clinical Epidemiology S.r.l.","duties_or_roles":"sponsorDuties codes: 1,10,11,12,5,6","organisation_type":"Pharmaceutical company"}