Allergic Rhinitis and / or Rhinoconjunctivitis with or without Intermittent Asthma MedDRA version: 18.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853 MedDRA version: 18.0 Level: LLT Classification code 10001705 Term: Allergic asthma System Organ Class: 100000004855 MedDRA version: 18.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855
Conditions
Interventions
Product Name: Depigoid® Phleum 1000 DPP/mL
Product Code: Depigoid® Phleum
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: see D.3.9.3.
Current Sponsor code: Depigoid® Phleum
Oth
Sponsors
LETI Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient 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 at Visit S1. 3. Has a perception of disease activity of at least 2 on a 4-point Lickert scale(moderate or severe). 4. Has an FEV1 value of > 80% of predicted normal at Visit S2. 5. Has complained about allergic rhinitis and/or rhino-conjunctivitis symptoms for at least 2 years, with or without intermittent asthma symptoms, caused by clinical sensitisation against grass pollen. The immunoglobulin E (IgE)-mediated sensitisation has to be verified by: - suggestive medical history AND - specific IgE against grass pollen using an ImmunoCAP specific IgE radioallergosorbent test (CAP-RAST) = 2 AND - positive skin prick test (SPT). An SPT will be considered positive if the test results in a wheal diameter that is at least 3 mm. The wheal for negative control must be =65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: A patient will NOT be eligible for inclusion in this study if ANY of the following criteria are met: 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], Spanish patients only), - with CAP-RAST co-allergen = grass, except for animal dander if not exposed to animal 3. Has uncontrolled / partly controlled asthma, according to Global Initiative for Asthma (GINA) Guidelines. 4. Has acute or chronic inflammatory or infectious diseases of the airways, sinuses or the conjunctiva. 5. Presence of clinically significant nasalnasal polyps 6. Anatomical deviations of the nasal Septum that significantly impair ventilation/airflow 7. Has chronic structural diseases of the lung (e.g., emphysema or bronchiectasis). 8. Has an autoimmune and/or immune deficiency. 9. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism). 10. Has a severe uncontrolled disease that could increase the risk of the patients participating in the study, which include, but are not limited to, the following: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases or haematological disorders. 11. Has had active malignant disease during the previous 5 years. 12. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient. 13. Has abused alcohol, drugs or medications within the past year. 14. Has a severe psychiatric, psychological or neurological disorder. 15. Has used immunotherapy against grass pollen within the last 5 years. 16. Has used systemic and/or topical treatment with ß blockers within 1 week prior to Visit T1. 17. 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 S1. 18. Has used tricyclic antidepressants or monoamine oxidase inhibitors within 1 week prior to Visit S3. 19. Has used systemic corticosteroids within 3 months prior to Visit S3. 20. Has been immunised with any vaccine within 7 days prior to Visit T1. 21. Is expected to be non-compliant and/or not co-operative. 22. Has participated in another clinical study within 30 days prior to Visit T1. 23. Has already participated in this study. 24. Is an employee at the investigational centre or first degree relative or partner of the investigator. 25. Plans to donate germ cells, blood, organs or bone marrow during the course of the study. 26. Is not contractually capable. 27. Has a positive pregnancy test at Visit S2. 28. Is jurisdictionally or governmentally institutionalised
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assessment of the effective dose range and the optimum dose of Depigoid® Phleum (vs. placebo) administered subcutaneously in adult patients with allergic rhinitis and/or rhinoconjunctivitis with or without intermittent asthma. Efficacy parameters will be assessed in an Environmental Challenge Chamber (ECC).;Secondary Objective: Assessment of additional efficacy parameters, safety and tolerability of 4 concentrations of Depigoid® Phleum (vs. placebo) administered subcutaneously during a treatment period of up to 20-weeks, and to gain some insight of the allergenic profile of the study patients before and after treatment with Depigoid® Phleum at different concentrations vs. placebo by component resolved diagnosis (sIgE patterns).;Primary end point(s): The primary endpoint is the reduction of the Total Nasal Symptoms Score (TNSS) assessed after provocation in an Environmental Challenge Chamber (ECC) in patients with grass pollen induced allergic rhinitis after treatment with up to 6*0,5 mL of IMP (4 different doses of Depigoid Phleum and Placebo) at intervals of 4 weeks versus baseline. The difference in reduction of the TNSS between the 4 doses of Depigoid Phleum versus placebo will be calculated. ;Timepoint(s) of evaluation of this end point: The results from the End of Study visit (Visit E1) will be compared to those at baseline (Visit S3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy endpoints will include: • Single symptoms during ECC •Nasal secretion during ECC •Change of lung function parameters before and after the administration of the IMP Secondary safety endpoints will include: • Patients (%) suffering from systemic reactions (Grades 1 to 5 WAO) 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 5 WAO) 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 • Physician’s overall tolerability assessment • Patient’s overall tolerability assessment Additional exploratory endpoints will include immunology laboratory parameters: total and specific IgE, specific IgG1 and IgG4 and component resolved diagnosis. ;Timepoint(s) of evaluation of this end point: During the treatment period | — |
Countries
Germany, Poland, Spain
Contacts
Public ContactMedical Department
LETI Pharma GmbH
Outcome results
None listed