Allergic rhinitis and/or allergic rhinoconjunctivitis with or without intermittent asthma. MedDRA version: 13.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 10015919 - Eye disorders MedDRA version: 13.1 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 13.1 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class
Conditions
Interventions
Product Name: Depigoid® Phleum
Product Code: Depigoid® Phleum
Pharmaceutical Form: Solution for injection
Current Sponsor code: Depigoid® Phleum
Other descriptive name: chemically modified extract of
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 or - if smaller - equal to the histamine reaction. A CPT will be considered positive if a score of 5 is achieved after treatment with any one of the following concentrations: 100, 330, 1,000, 3,300 or 10,000 SQ-U/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, • with specific IgE CAP-RAST co-allergen =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Patients presenting any one of the following exclusion criteria must not be included in the study: 1. Acute, chronic or 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, • with CAP-RAST co-allergen = grass. 3. Has persistent asthma, according to Global Initiative for Asthma (GINA) Guidelines 32. 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: The primary objective of this study is to assess the 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: To assess the safety and tolerability of 4 different concentrations of Depigoid® Phleum administered subcutaneously during a 20-week treatment period.;Primary end point(s): Percentage of patients who need an increased amount of allergen to elicit a positive CPT performed after 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: At screening and after approx 22 weeks (EoS) Comparison between dosage groups of percentage of patients who need an increased amount of allergen to provoke a positive CPT at the end of the treatment. It is expected that at the end of the study higher doses are necessary to provoke a positive CPT. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All secondary endpoints are safety endpoints.;Timepoint(s) of evaluation of this end point: The safety endpoints with the number and percentage of patients suffering from local or systemic reactions and those being withdrawn due to local or systemic reactions will be presented in an AE summary table together with the corresponding 95% confidence intervals. | — |
Countries
Bulgaria, Czech Republic, Hungary
Contacts
Public ContactMedical Department
LETI Pharma GmbH
Outcome results
None listed