Grass Pollen Immunotherapy Plus Dupilumab For Tolerance Induction (GRADUATE)

Principal Investigator

Stephen R. Durham, MD | Imperial College, London

Locations

Royal Brompton Hospital | London, UK

Study Code

ITN084AD

Study Status

Active

Abstract

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 reduces symptoms of hay fever and modifies the allergic disease by increasing tolerance to the grass pollen.

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

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 general health and hayfever symptoms
Follow-up Period	1 year	Monthly phone calls and 5 visits throughout the year to check on progress

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If eligible, participants will receive medical advice about their hay fever and rescue medications (like antihistamines and nasal sprays) in season as needed, as well as compensation for expenses.