Treatment of seasonal allergic rhinitis to grass pollen.
Conditions
Interventions
Product Name: Microencapsulated grass pollen extract
Product Code: MGPE
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Grass Pollen Extract (GPE)
CAS Number: N/A
Current Sponsor code: GPE
Oth
Sponsors
Curalogic A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Signed informed consent; 2. 18 to 65 years old; both inclusive; 3. Have a history of two consecutive seasons of summer, seasonal allergic rhinitis from the end of May with a maximum during June and July that has required repeated treatment with antihistamines, leukotriene antagonists, nasal steroids, or topical cromones; 4. Have a positive skin prick test (SPT) to a standardized grass pollen extract (Phleum pratense) performed within the last six months before screening, which is defined as: • Diameter of the weal of at least the size of the positive control (histamine-dihydrochloride) and • Diameter of weal of at least 5 mm; 5. Have a grass-specific (Phleum pratense) IgE concentration of at least 0.7 kU/L using the Phadia ImmunoCAP assay (Freiburg, Germany); 6. Will be available for visits at the Clinical pharmacology research unit (CPRU) for the duration of the study; 7. Have a negative blood pregnancy test (women of childbearing potential). Women of childbearing potential, who are sexually active, must be consistently using a highly effective double method of contraception. 8. Are able to understand the study requirements and comply with study instructions. 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 F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have a chronic or acute disease that, in the opinion of the Investigator, might interfere with the evaluation of the data for the IMP or might place the subject at additional risk; 2. Have a severe autoimmune disease or a severe immunodeficiency; 3. Have a neoplastic malignancy with present clinical relevance; 4. Have perennial or structurally related rhinitis, including vasomotor rhinitis, i.e., require treatment of the allergic symptoms with antihistamines or nasal steroids during the months of December and January; 5. Unable to comply with the study schedule and procedures; 6. Are currently receiving immunotherapy to any allergens or have received grass immunotherapy within three years before the Screening Visit (immunotherapy to other allergens than grass discontinued within 90 days before the Screening Visit is allowed); 7. Have moderate to severe persistent asthma (Global Initiative for Asthma, GINA, criteria III and IV) requiring daily "controller" medications (moderate to high doses of inhaled corticosteroids, long-acting bronchodilators, leukotriene antagonists) or use "rescue" medication (salbutamol for inhalation or similar short-acting bronchodilators) more than four times weekly at any time during the year; 8. Have insufficiently treated asthma and/or irreversible airway obstruction with a value of forced expiratory volume (FEV1) <70% of predicted (mean out of three acceptable values) despite of asthma medication 9. Repeated or daily use of proton pump inhibitors within one week before the Screening Visit and throughout the study; 10. Use prohibited medications or have inadequate washout periods before the start of the study. The following medications are prohibited during the study and if taken before the study, the required wash-out periods are indicated in brackets: • Oral corticosteroids (one month); • Antihistamines: o H1-blocker (three days), • Anti-lgE medication (six months), • Tricyclic antidepressants (14 days); 11. Have significant chronic sinusitis as assessed by the Investigator; 12. Have Rhinitis medicamentosa from excessive use of nasal decongestants (e.g., oxymetazoline); 13. History of hypersensitivity to the IMP or its excipients (subjects enrolled in this study are expected to be allergic to grass). Hypersensitivity to the IMP means that the subject has had a previous systemic or severe local reaction to grass extract previously used for SPT or immunotherapy; 14. Are pregnant or lactating; 15. Participation in another study with any IMP in the three months before the study; 16. Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ; 17. Blood or plasma donation of more than 500 mL during the month before the study and more than 50 mL within the two weeks before Day 1; 18. Positive test results for HIV1 and HIV2 virus, or for Hepatitis B surface-antigen (HBsAg ) or Hepatitis C virus antibody; 19. Current evidence of drug abuse or history of drug abuse within 18 months before the study, including history of alcohol abuse or active alcoholism; 20. Inability to understand the protocol requirements, instructions and study-related restrictions; the nature, scope, and possible consequences of the study; 21. Unlikely to comply with the protocol requirements, instructions and study-related restrictions; e.g., uncooperative attitude, inability to return for Follow-up Visits, and improbability of completing the study; 22. Subject is the Investi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To establish the maximal tolerated dose of Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE) in subjects allergic to grass pollen.;Secondary Objective: To evaluate safety and tolerability of escalating doses of Microencapsulated Grass (Phleum pratense) Pollen Extract (MGPE).;Primary end point(s): Adverse events • Allergic serious adverse event • Severe systemic reaction • Diarrhea >40% of the subjects on active IMP with =Grade I (definite/possible/probable causality to the IMP) o >30% of the subjects on active IMP with =Grade II (definite/possible/probable causality to the IMP) o >10% of the subjects on active IMP with =Grade III (definite/possible/probable causality to the IMP) • Nausea/Vomiting o >10% of the subjects on active IMP with =Grade II (definite/possible/probable causality to the IMP) Immunoglobulin Grass specific immunoglobulin (IgG and IgG4) Cellular immune response by grass specific T-cell proliferation | — |
Countries
Germany
Outcome results
None listed