ALLERGENIC EXTRACT OF JUNIPERUS OXYCEDRUS POLLEN POLYMERIZED WITH GLUTARALDEHYDE; ALLERGEN EXTRACT FROM PHLEUM PRATENSE POLLEN, GLUTARALDEHYDE-MODIFIED; FESTUCA PRATENSIS POLLEN ALLERGOID, GLUTARALDEHYDE-MODIFIED; HOLCUS LANATUS POLLEN ALLERGOID, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM POA PRATENSIS POLLEN, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM DACTYLIS GLOMERATA POLLEN, GLUTARALDEHYDE-MODIFIED; ALLERGEN EXTRACT FROM LOLIUM PERENNE POLLEN, GLUTARALDEHYDE-MODIFIED for Allergic rhinitis | Allergic rhinoconjunctivitis | Allergic asthma | Pollen allergy

Inclusion criteria

• {"criterion_text":"- 1.\tSubject who has signed the informed consent form.\n- 2.\tSubjects of both sexes aged between 12 and 65 years.\n- 3.\tSubjects with a confirmed clinical history of inhalation allergy (moderate-severe intermittent or persistent rhinitis and/or rhinoconjunctivitis according to the ARIA classification, with or without mild-moderate controlled intermittent or persistent asthma according to the GEMA 5.0 classification) caused by grass and cupressaceae allergy. The diagnosis of asthma will be valid from 12 months prior to signing the informed consent.\n- 4.\tSubjects with a positive skin prick test (wheal major diameter ≥ 5 mm) to a standardised extract mixture of grass pollen (Phleum pratense, Holcus lanatus, Dactylis glomerata, Poa pratensis, Festuca elatior, Lolium perenne), or to one of the components of the mixture and a cupressaceae extract. In addition, the wheal major diameter must be greater than or equal to that of the histamine.\n- 5.\tSpecific IgE (CAP or Immulite) to a grass mixture or to one of the components of the grass mixture, preferably to Phleum pratense and cupressaceae or to one of the molecular components of the allergenic sources with a value > 3.5 KU/L.\n- 6.\tWomen of childbearing age (from menarche) must present a urine pregnancy test with negative result at the time of entry into the trial.\n- 7.\tWomen of childbearing age participating in the trial must agree to use an appropriate method of contraception. Medically acceptable methods of contraception are intrauterine devices inserted at least 3 months in advance, surgical sterilisation (e.g., tubal ligations), barrier methods, or the use of oral contraceptives.\n- 8.\tSubjects able to comply with the dosing regimen.\n- 9.\tSubjects with a smartphone to record symptoms and medication consumption.\n- 10.\tSubjects with negative skin test for co-seasonal pollens. In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs.\n- 11.\tSubjects with negative skin test for other aeroallergens (mites, dander, and fungi). In case specific IgE determination has been performed, the result must be < 3.5 kU/L and without relevant clinical signs."}

Exclusion criteria

• {"criterion_text":"- 1.\tSubjects with positive skin prick test to other aeroallergens, except for dander with occasional exposure and symptomatology.\n- 2.\tSubjects with positive skin prick test for other aeroallergens, except for non-co-seasonal pollens with grasses and cupressaceae.\n- 3.\tSubjects who have received immunotherapy to pollens in the last 5 years or are currently receiving immunotherapy with any allergen.\n- 4.\tSubjects in whom immunotherapy may be subject to absolute general contraindication according to the criteria of the Immunotherapy Committee of the Spanish Society of Allergy and Clinical Immunology and the European Allergy and Clinical Immunology Immunotherapy Subcommittee.\n- 5.\tSubjects with severe or uncontrolled persistent asthma, with an FEV1<70% of baseline despite adequate pharmacological treatment at the time of inclusion in the trial. Also subjects with intermittent or persistent rhinitis/rhinoconjunctivitis with severe symptoms in whom discontinuation of oral or systemic antihistamine treatment is contraindicated.\n- 6.\tSubjects who have previously exhibited a severe secondary reaction during diagnostic skin prick test.\n- 7.\tSubjects on treatment with ß-blockers.\n- 8.\tClinically unstable subjects at the time of inclusion in the trial (acute asthma exacerbation, respiratory infection, febrile process, acute urticaria, etc.).\n- 9.\tSubjects with chronic active urticaria, severe dermographism, severe atopic dermatitis, sunburn, active psoriasis with lesions in areas where skin prick test will be performed, or a history of hereditary angioedema.\n- 10.\tSubjects with any pathology in which the administration of adrenaline is contraindicated (hyperthyroidism, hypertension, heart disease, etc.).\n- 11.\tSubjects with any other disease not related to moderate rhinoconjunctivitis or asthma, but of potential severity and that may interfere with treatment and follow-up (epilepsy, psychomotor impairment, uncontrolled diabetes, malformations, multiple surgeries, nephropathies).\n- 12.\tSubjects with autoimmune disease (thyroiditis, lupus, etc.), tumour diseases or diagnosed with immunodeficiencies.\n- 13.\tSubject whose condition prevents him/her from offering cooperation and/or who has severe psychiatric disorders.\n- 14.\tSubjects with known allergy to components of the investigational medicinal product other than the allergen.\n- 15.\tSubjects with lower respiratory tract diseases other than asthma such as emphysema or bronchiectasis.\n- 16.\tSubjects who are immediate family members of investigators.\n- 17.\tPregnant or breastfeeding women."}

Primary endpoints

• {"endpoint_text":"- Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) during the pollen season and pollen peak of cupressaceae (January, February and March) and grasses (May and June).","definition_or_measurement_approach":"Measured as the Combined symptom and medication score in rhinitis/rhinoconjunctivitis (RCSMS) recorded during the pollen seasons/pollen peaks (Cupressaceae: January–March; Grasses: May–June)."}

Secondary endpoints

• {"endpoint_text":"- Symptom free days in rhinitis/rhinoconjunctivitis and asthma\n- Medication-free days in rhinitis/rhinoconjunctivitis and asthma\n- Symptom score in rhinitis/rhinoconjunctivitis (RSS) during pollen season and pollen peak of grasses and cupressaceae.\n- Medication score in rhinitis/rhinoconjunctivitis (RMS) during pollen season and pollen peak of grasses and cupressaceae.\n- Combined symptom and medication score (ACSMS) during pollen season and pollen peak of grasses and cupressaceae.\n- Asthma symptom score (ASS) during pollen season and pollen peak of grasses and cupressaceae.\n- Asthma Medication Score (AMS) during pollen season and pollen peak of grasses and cupressaceae.\n- Asthma and rhinitis/rhinoconjunctivitis symptom score (ARSS) during pollen season and pollen peak of grasses and cupressaceae.\n- Asthma and rhinitis/rhinoconjunctivitis medication score (ARMS) during pollen season and pollen peak of grasses and cupressaceae\n- Combined symptom and medication score in asthma and rhinitis/rhinoconjunctivitis (ARCSMS) during pollen season and pollen peak of grasses and cupressaceae.\n- Asthmatic exacerbations: time to first occurrence of asthmatic exacerbation, number, duration and severity.\n- Visual Analogue Scale (VAS)\n- Immunological parameters (total IgE, specific IgE and specific IgG4).\n- Asthma Control Questionnaire (ACQ-6).\n- Rhinitis Follow-up Questionnaire (ESPRINT-15).\n- Register of consumption of health resources.\n- Safety of specific immunotherapy (Overall rate, severity, and ratio of any adverse event (AE) by administration and by subject; Evaluation of administration site reactions, systemic reactions and any medication administered for the treatment of AE)","definition_or_measurement_approach":"Secondary endpoints comprise symptom and medication-based scores and clinical outcomes measured during pollen season/pollen peaks (various scores defined in protocol: RSS, RMS, ASS, AMS, ARSS, ARMS, ARCSMS), symptom-free and medication-free days, VAS, immunological parameters (total IgE, specific IgE, specific IgG4), ACQ-6, ESPRINT-15, health resource use register, and safety assessments (AE rates, severity, administration-site and systemic reactions). Timing: during pollen season/pollen peaks as specified."}

Spain

Latest Decision Or Authorization Date

05-09-2025

Number Of Sites

23

Number Of Participants

180

Primary sponsor

Full Name

Inmunotek S.L.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Spain