HAL-MRE1 Subcutaneous Immunotherapy in Ragweed Allergic Patients First-in-human
Canada45 participantsStarted 2018-11-21
Plain-language summary
The aim of this first-in-human phase I study is to assess the safety and tolerability of HAL-MRE1 subcutaneous immunotherapy in subjects suffering from ragweed pollen-induced allergic rhinitis/rhinoconjunctivitis with or without asthma.
The study has 4 treatment groups: 1 placebo group and 3 groups treated with different doses of HAL-MRE1.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Signed informed consent.
✓. Male or female subjects aged ≥18 and ≤65 years.
✓. Documented diagnosis of allergic rhinitis/rhinoconjunctivitis (ARC) to ragweed pollen. A documented diagnosis is a documented medical history of ARC symptoms that required treatment after ragweed pollen exposure. Subjects experienced allergy symptoms that required treatment during the previous 2 ragweed seasons, with or without concomitant asthma (asthma must be controlled).
✓. Positive nasal provocation test for ragweed pollen at screening or within the last 6 months.
✓. Positive skin prick test to ragweed allergen at screening or within the last 6 months.
✓. Positive serum specific IgE test for ragweed allergen (IgE level ≥0.7 U/mL).
✓. Forced expiratory volume \>70 % or peak expiratory flow \>80 % of predicted value.
✓. For asthmatic subjects: asthma control test (ACT) score ≥20.
Exclusion criteria
✕. History of anaphylaxis with cardio respiratory symptoms (food allergy, venom allergy, drugs or/and idiopathic reaction).
✕. Alcohol, drug or medication abuse in the past.
✕. Any clinically significant abnormal laboratory parameter at screening as per investigator's discretion.
✕
What they're measuring
1
Occurence of local and systemic reactions
Timeframe: Through study completion, approximately 10 weeks
. Clinically relevant sensitization to other allergens if clinical symptoms are expected during the study.
✕. Uncontrolled asthma.
✕. Participation in a clinical interventional study within the last 3 months (e.g. new investigational drug or biological), or plans to participate in another clinical trial during this study, or participation in an observational study (e.g. post marketing study) within the last 30 days unless the observational study aimed to investigate the intradermal test.
✕. Subjects who received immunotherapy for any specific allergen 3 years prior to screening or during the study period.
✕. Subjects who were ever treated with any ragweed allergen specific immunotherapy.