Allergic rhinoconjunctivitis induced by Cupressus arizonica pollen. MedDRA version: 16.1 Level: PT Classification code 10039085 Term: Rhinitis allergic System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Name: AVANZ® Cupressus arizonica
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Cupressus arizonica
Other descriptive name: CUPRESSUS ARIZONICA WHOLE
Concentration unit: SQ
Sponsors
ALK-Abelló, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female aged 18-65 years. A documented clinically relevant history of Cupressus arizonica pollen induced allergic rhinoconjunctivitis with or without asthma for at least one year prior to trial entry. Positive Skin Prick Test (SPT) response to Cupressus arizonica pollen (wheal diameter ? 3 mm) . Documenting in the last 5 years a positive specific IgE against Cupressus arizonica pollen (? Class 2; ?0.70 KU/L). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: A clinical history of uncontrolled asthma within 3 months prior to screening . Reduced lung function (FEV1 < 70% of predicted value) after adequate pharmacologic treatment. History of severe asthma exacerbation or emergency room visit or admission for asthma in the previous 12 months. Previous treatment with immunotherapy with Cupressus arizonica pollen extract within the last 5 years Ongoing treatment with any allergen-specific immunotherapy product. At screening, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant process. A history of anaphylaxis with cardiorespiratory symptoms. A history of recurrent generalised urticaria during the last 2 years. A history of drug-induced facial angioedema or a family history of hereditary angioedema. Any clinically relevant chronic disease A systemic disease affecting the immune system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica.;Secondary Objective: To assess the tolerability of the up-dosing phase of AVANZ® Cupressus arizonica based on the incidence of systemic adverse reactions. To evaluate the changes in IgG4 and IgE for Cupressus arizonica. To evaluate the reduction in immediate skin reactivity for Cupressus arizonica.;Primary end point(s): The primary endpoint will be the frequency of patients with IMP-related AEs.;Timepoint(s) of evaluation of this end point: After updosing phase and one maintenance dose (6 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of systemic adverse reactions (grade I or higher) occurred after AIT, classified according to the EAACI Immunotherapy Task Force. Changes in Cupressus arizonica specific IgG4 and IgE from baseline to end of treatment. Changes in immediate skin response to Cupressus arizonica from baseline to end of treatment as measured by parallel line assay (PLA).;Timepoint(s) of evaluation of this end point: After updosing phase and one maintenance dose (6 weeks) | — |
Countries
Spain
Contacts
Public ContactDepartamento Médico
ALK-Abelló S.A.
Outcome results
None listed