Patients with allergic rhinitis or rhinoconjunctivitis, with or without asthma, controlled by triple sensitization to grass pollen, Olea europaea and Salsola kali, susceptible to treatment with immunotherapy. MedDRA version: 17.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870
Conditions
Interventions
Product Name: Depigoid GrassesMix/Olea europaea/Salsola kali 3000 DPP/ml
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Depigmented modified 34% GrassesMix/33% Olea europaea/33% Sa
Sponsors
Laboratorios LETI, S.L. Unipersonal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who have dated and signed informed consent and are able to comply with study procedures. 2. Patients aged over 18 years and under 70 years of age at selection visit. 3. Has an FEV1 or a PEFR value equal or superior to 80% of predicted normal value at selection Visit. 4. Individuals suffering from allergic rhinitis and/or rhinoconjunctivitis for at least the preceding year, with or without controlled asthma, caused by triple sensitization against Grasses, Olea europaea and Salsola kali. - The IgE-mediated sensitization must be verified by the following: Suggestive medical history, and Specific IgE to GrassesMix, Olea europaea and Salsola kali > class II; and positive skin prick test (SPT) to GrassesMix, Olea europaea and Salsola kali. A SPT will be considered positive when it produces a wheal whose diameter is at least 3 mm. - Asthmatic subjects can be included in the trial only if allergic asthma is controlled according to the Global Initiative for Asthma (GINA 2010) - Asthmatic subjects must be stable within 3 months prior to Visit 1 and on a stable inhaled steroid dose within 6 weeks prior to Visit 1 and throughout the study. 5. If a female is of non-childbearing potential, the subject must be postmenopausal for at least 1 year or surgically sterile (e.g., bilateral tubal ligation, bilateral oophorectomy, or hysterectomy). 6. If a female is of childbearing potential, the subject must be non-lactating and non-pregnant (with a negative pregnancy test result at Visit 1) and must correctly use an effective method of contraception during the study. An effective method of contraception is defined as one that results in a failure rate of less than 1% per year. The following are allowed methods of contraception when used continuously and properly: hormonal contraceptives administered by implant, injection, or orally; complete abstinence; partner?s vasectomy if the female has not more than one partner. Barrier methods (e.g., preservatives) are only considered effective if used together with one of the above. 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 71 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 71
Exclusion criteria
Exclusion criteria: 1. Any contraindication for treatment with allergen immunotherapy. 2. Subjects with a previous history of anaphylaxis. 3. Patients with hospital admission due to asthma exacerbations within 1 year prior to V1. 4. Has uncontrolled allergic asthma, according to Global Initiative for Asthma Guidelines (GINA 2014f). 5. Acute or chronic infectious conjunctivitis. 6. Has acute or chronic inflammatory or infectious airways disease. 7. Has chronic structural diseases of the affected organ (e.g. eye, nose, lung). 8. History or presence of confirmed or potential diseases of the immune system including autoimmune diseases and immune deficiencies of actual clinical relevance. 9. Has any disease that prohibits the use of adrenaline (e.g., hyperthyroidism). 10. Has a severe uncontrolled disease that could increase the risk to the subjects 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. 11. Subjects with chronic urticaria. 12. Subjects with moderate-severe atopic dermatitis (subjects with a SCORAD value >30 can not participate in the study). 13. Has had active malignant disease during the previous 5 years. 14. Has a significant abnormal laboratory parameter or alteration in vital signs that could increase the risk to the study patient. 15. Has used immunotherapy with allergen extracts from Grasses, Olea europaea or Salsola kali within the last 5 years or is receiving allergen specific immunotherapy with other allergens during the study period. 16. Has used systemic and/or topical treatment with beta-blocker drugs within 1 week prior to Visit 2 (first IMP administration). 17. Used psychotropic, tricyclic, tetracyclic and MAOI antidepressants within 1 month prior to Visit 1. It will not be allowed to perform a washout period of psychotropic or antidepressants to enter the study because of the risks of interrupting the treatment. 18. Used systemic corticosteroids within 3 months prior to Visit 1. 19. Treatment with substances interfering with the immune system 2 weeks before Visit 2 (first IMP administration). 20. Immunization with prophylactic (bacterial or viral) vaccines within 7 days prior to Visit 2 (first IMP administration). Prophylactic vaccines are allowed during the administration of IMP period provided they are administered at least one week after immunotherapy and the next immunotherapy dose is administered at least 14 days later. 21. Exposure to any investigational drug within one month or 6 half lives of the drug (whichever is longer). 22. Has abused alcohol, drugs or medications within the past year prior to Visit 1. 23. Lack of cooperation or compliance with study procedures. 24. Subjects with severe psychiatric, psychological, neurological disorders or mental condition which unable the subject to understand the nature, scope and possible consequences of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of two different doses of Depigoid 34% GrassesMix, 33% Olea europaea and 33% Salsola kali at 3000 DPP/ml in subjects with allergic rhinitis or rhinoconjunctivitis, with or without controlled asthma.;Secondary Objective: Evaluating the mechanism of action of treatment administered subcutaneously DP/MG/14-13 by measuring immunoserological laboratory parameters: specific IgE and IgG4.;Primary end point(s): Number of subjects (%) suffering from immediate or delayed systemic ? grade 2 reactions, according to EACCI 2006 classification, along the study.;Timepoint(s) of evaluation of this end point: During study visits. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points: - Patients (%) sufering from immediate or delayed local reactions classified by the diameter of induration and dose received - Patients (%) suffering from immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received - Patients (%) withdrawn from the study due to local reactions classified by dose received - Patients (%) withdrawn from the study due to local reactions classified by dose received during the build-up phase - Patients (%) withdrawn from the study due to systemic reactions classified by dose received - Patients (%) withdrawn from the study due to systemic reactions classified by dose received during the build-up phase - Patients (%) with adverse events (AE) classified by dose received - Number of immediate or delayed local reactions classified by diameter of induration and dose received - Number of immediate or delayed systemic reactions classified by grade (EACCI classification) and dose received - Change of lung function parameters before and after each administration of the IMP. - Change from baseline to Visit 4 in laboratory parameters Exploratory end points: - Immunologic response measured by immunology laboratory parameters: specific IgE and IgG4 to the complete allergenic extracts of GrassMix, Olea europaea and Salsola kali.;Timepoint(s) of evaluation of this end point: During study visits. | — |
Countries
Spain
Contacts
Public ContactLiana de Plasencia Mascuñana
Dynamic Science S.L.
Outcome results
None listed