Welcome to the GRADUATE Study
GRADUATE is a clinical research trial, which will test whether a novel drug called Dupixent® given with grass pollen immunotherapy will help the immunotherapy work in a shorter treatment period and remain effective after the completion of treatment. Immunotherapy not only reduces symptoms of hay fever, but modifies the allergic disease by increasing tolerance to the grass pollen.
Participating in GRADUATE
We want to hear from volunteers at any time of year. Participants in the GRADUATE study will be asked to start treatment a while before the hay fever season begins, and will be randomly assigned to one of three groups who will be given:
- Grazax® plus Dupixent®
- Grazax® plus placebo (an inactive substance made to look like the study drug)
- placebo plus placebo
You cannot pick your group. A computer randomly picks who will be in which group. Neither you nor the study team will know your group. After all participants have finished the study, we will tell you which group you were in.
The total study length is 3 years. The study visits are summarized below:
|Treatment Period||2 years||Visits every 4 weeks to provide treatment and monitor your general health and hayfever symptoms|
|Follow-up Period||1 year||Monthly phone calls and 5 visits throughout the year to check on progress|
If eligible, you will receive medical advice about your hay fever and rescue medications (like antihistamines and nasal sprays) in season as needed, as well as compensation for your expenses.
About the Investigational Study Drugs
Grazax® is a sublingual (placed under the tongue) daily tablet for treatment of moderate to severe seasonal grass pollen allergy. It has been approved for use in the UK, Europe and USA. Studies have demonstrated that Grazax® is effective at reducing seasonal symptoms of hay fever during 3 years of daily treatment.
Dupixent (also known as dupilumab) is an antibody, like the ones your body makes when you have an infection. This antibody has been made in the laboratory to interrupt the immune system's allergic response. While Dupixent has not been studied in grass allergy, it is currently approved by the European Medicines Agency (EMA) for treatment of severe asthma, atopic dermatitis and nasal polyps.