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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Occurence of local and systemic reactions
Timeframe: Through study completion, approximately 10 weeks
. 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.
. 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.