Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy

Launched by HAL ALLERGY · Sep 21, 2015

Keywords

ClinConnect Summary

The current dose range finding study with SP has been designed to test three different concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000 AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the minimal effective dose of SP. The study will be conducted in the target population of seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system. The EEC system is a facility that has temporal uniformity of airborne allergen (pollen) exposure to subjects. Use of the EEC ensures exposure to relat...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects who signed informed consent.
• • 2. Subjects aged ≥18 and ≤65 years at signing of informed consent.
• • 3. Subjects with at least two-year clinical history of allergic rhinitis/rhinoconjunctivitis to grass pollen, with or without concomitant asthma (asthma must be controlled).
• • 4. Subjects with a forced expiratory volume at one second (FEV1) \>70% of the predicted value as measured during screening or documented within 1 year of study start.
• • 5. Subjects with a positive skin prick test (SPT) (mean wheal diameter of at least 3 mm larger than the negative control; negative control should be \<2 mm, histamine control should be positive (mean wheal diameter of at least 3 mm larger than the negative control)) for grass pollen assessed during screening or a documented positive response obtained within 1 year before screening.
• • 6. Subjects with a grass pollen specific IgE greater than or equal to 0.7 kiloUnits (kU)/L assessed during screening or a documented positive result obtained within 1 year before screening.
• • 7. Subjects with a TSS of at least 10/24 during baseline EEC challenge (V2) in combination with a staff assessed score of at least 2/3 for two objective TSS symptoms (i.e. running nose, sneezing or red eyes), during the baseline EEC challenge.
• Exclusion Criteria:
• • 1. Subjects with (expected) clinically relevant symptoms at the timing of the scheduled EEC assessments at Visit 2 and Visit 6 due to concomitant sensitization i.e. positive SPT (mean wheal diameter of at least 3 mm larger than the negative control) and a history of allergic response to the causative allergen, at the discretion of the investigator.
• • 2. Patients with grass pollen induced asthma.
• • 3. Subjects who cannot tolerate the Baseline Challenge in the EEC.
• • 4. Subjects who received immunotherapy (SCIT or SLIT) with grass pollen allergens within the past 5 years.
• • 5. (Ongoing) allergen-specific immunotherapy with any allergen(s) during the study period.
• • 6. Subjects with unsuccessful allergen-specific immunotherapy within the past 5 years (e.g., but not limited to, prematurely stopped immunotherapy due to non-compliance, AEs or lack of therapeutic effect), at the discretion of the investigator.
• • 7. Subjects undergoing anti-IgE therapy within the 6 months prior to inclusion and/or during the study.
• • 8. Subjects suffering from severe immune disorders (including auto-immune diseases) and/or diseases requiring immunosuppressive drugs.
• • 9. Subjects suffering from active malignancies or any malignant disease (except for localized basal cell cancers of the skin as long as they have been adequately treated and no recurrence within 3 months of screening visit) during 5 years prior to screening.
• • 10. Subjects suffering from severe uncontrolled diseases that could increase the risk for participating in the study, including but not limited to: cardiovascular insufficiency, any severe or unstable lung diseases, endocrine diseases, clinically significant renal or hepatic diseases, or haematological disorders at the discretion of the Investigator.
• • 11. Subjects who have active inflammation or infection of the target organs (nose, eyes or lower airways) at Visit 1.
• • 12. Subjects suffering from diseases with a contraindication for the use of adrenaline (e.g. hyperthyroidism, glaucoma).
• • 13. Subjects receiving vaccination within one week before start of therapy or during the up-dosing phase.
• • 14. Subjects receiving treatment with systemic steroids within 4 weeks before visit 1 and/or during the study.
• • 15. Subjects receiving treatment with systemic or local β-blockers anytime during the study.
• • 16. Subjects who participated in a clinical study within the last 3 months (e.g. new investigational drug or biological) or within the last 30 days (e.g. bio-equivalent drug), at the discretion of the Investigator.
• • 17. Female subjects of child-bearing potential who are pregnant, lactating or using inadequate contraceptive measures (adequate contraceptive measures will be: sexual abstinence; oral contraceptives, trans dermal patches or depot injection of a progestogen drug (starting at least 4 weeks prior to investigational medicinal product (IMP) administration); double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent; intrauterine device (IUD), intrauterine system (IUS), implant, or vaginal ring (placed at least 4 weeks prior to IMP administration); or male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into trial and is the sole sexual partner for that female subject.
• • 18. Subjects that have a history of alcohol, drug or medication abuse within the past year before study start.
• • 19. Subjects with any clinically relevant abnormal laboratory parameter at screening.
• • 20. Subjects that lack cooperation or compliance, as judged by the investigator.
• • 21. Subjects suffering from severe psychiatric, psychological, or neurological disorders.
• • 22. Subjects who are employees of the sponsor or contract research organisation and/or 1st grade relatives or partners of the (principal) investigator.