Allergic Rhinitis and/or Rhinoconjunctivitis with or without Intermittent Asthma MedDRA version: 14.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 14.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 MedDRA version: 14.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Product Name: Depigoid® Phleum 100 DPP/ml
Product Code: Depigoid® Phleum
Pharmaceutical Form: Suspension for injection
Current Sponsor code: Depigoid® Phleum
Other descriptive name: Chemically modifie
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must meet ALL the following inclusion criteria to be considered for admission to the study: 1. Has provided appropriately signed and dated informed consent. 2. Is a male or female aged = 18 years and = 70 years of age at Visit 1. 3. Has a perception of disease activity of at least 30 mm on a 100 mm VAS. 4. Has an FEV1 or a PEFR value > 80% of predicted normal value. 5. Has complained about allergic rhinitis and/or rhinoconjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The IgE-mediated sensitisation must be verified by the following: suggestive medical history AND specific IgE against grass pollen using an ImmunoCAP specific IgE radioallergosorbent test (CAP-RAST) = 2 AND a positive SPT AND a positive CPT for grass pollen. An SPT will be considered positive if the test results in a wheal diameter that is at least 3 mm. A CPT will be considered positive if a score of 5 is achieved after treatment with any one of the following concentrations: 0.03, 0.1, 0.3, 1, or 3 HEP/mL. Patients with co-allergies are allowed to enter the study: • being asymptomatic against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]), ? with specific IgE CAP-RAST and SPT co-allergen, as specified below: o Pollen co-allergen and house dust mites: specific IgE CAP-RAST =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: Patients presenting any one of the following exclusion criteria must not be included in the study: 1. Acute or chronic infectious conjunctivitis. 2. Has a history of significant clinical manifestations of allergy as a result of sensitisation against trees or weed pollen and perennial allergens (e.g., house dust mites). Patients are not allowed to enter into the study: ? with typical symptoms against co-allergens such as tree or weed pollen, house dust mites, cat and dog, and other country specific allergens (e.g. but not limited to Olea europaea [olive tree], Parietaria judaica [wall pellitory], Ambrosia elatior [ragweed]), ? with CAP-RAST co-allergen = grass, except animal dander if not exposed CAP-RAST animal dander > grass. 3. Has persistent asthma, according to Global Initiative for Asthma (GINA) Guidelines32. 4. Has acute or chronic inflammatory or infectious airways disease. 5. Has chronic structural disease of the lung (e.g., emphysema or bronchiectasis). 6. Has an autoimmune and/or immune deficiency. 7. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism). 8. Has a severe uncontrolled disease that could increase the risk to the patients while participating in the study, including but not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders. 9. Has had active malignant disease during the previous 5 years. 10. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient. 11. Has abused alcohol, drugs or medications within the past year. 12. Has a severe psychiatric, psychological or neurological disorder. 13. Has used immunotherapy against grass pollen within the last 5 years. 14. Has used systemic and/or topical treatment with ß-blockers within 1 week prior to Visit 2. 15. Is using any medication that may interfere with the immune system or has been using any medication which might still have an influence on the immune system at Visit 2. 16. Has used tranquiliser or psychoactive drugs within 1 week prior to Visit 1. 17. Has used systemic corticosteroids within 3 months prior to Visit 1. 18. Has been immunised with vaccines within 7 days prior to Visit 2. 19. Is expected to be non-compliant and/or not cooperative. 20. Has participated in another clinical study within 30 days prior to Visit 2. 21. Has already participated in this study. 22. Is an employee at the investigational centre or first degree relative or partner of the investigator. 23. Plans to donate germ cells, blood, organs or bone marrow during the course of the study. 24. Is not contractually capable. 25. Has a positive pregnancy test at Visit 1. 26. Is jurisdictionally or governmentally institutionalised.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of effective dose range and the optimum dose of Depigoid® Phleum administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.;Secondary Objective: Assessment of safety and tolerability of 4 different concentrations of Depigoid® Phleum administered subcutaneously during an up to 20-week treatment period. Exploration of mechanism of action of the treatment with Depigoid® Phleum administered subcutaneously by measuring immunology laboratory parameters in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. Assessment of the influence of baseline vitamin D levels on the efficacy of an up to 20-week treatment period with Depigoid® Phleum administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma.;Primary end point(s): Percentage of patients who need an increased amount of allergen to elicit a positive CPT performed after up to 20 weeks of treatment in comparison to baseline (i.e.; comparing the results from follow-up Visit 8 with those at baseline (Visit 1).;Timepoint(s) of evaluation of this end point: CPT baseline to visit 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary safety endpoints are: • Patients (%) suffering from systemic reactions (Grades 1 to 4) during the treatment period, • Patients (%) suffering from local reactions during the treatment period, • Patients (%) withdrawn from the study due to systemic reactions (Grades 1 to 4) during the build-up phase, • Patients (%) withdrawn from the study due to local reactions during the build-up phase, • Patients (%) suffering from different severity levels of systemic reactions during the treatment period, • Patients (%) suffering from different severity levels of local reactions during the treatment period, • Patients (%) withdrawn from the study due to systemic reactions during the treatment period, • Patients (%) withdrawn from the study due to local reactions during the treatment period, • Change from baseline to the end of the treatment period in the clinical chemistry and haematological parameters, • Change of lung function parameters before and after the administration of the IMP, • Physician’s overall tolerability assessment, • Patients’ overall tolerability assessment. • Immunology laboratory parameters: total and specific IgE, specific IgG1 and IgG4 and FAB assay, • Baseline vitamin D levels versus efficacy outcome.;Timepoint(s) of evaluation of this end point: during treatment period | — |
Countries
Czech Republic, Germany, Poland, Spain
Contacts
Public ContactMedical Department
LETI Pharma GmbH
Outcome results
None listed