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Grass Immunotherapy plus Dupilumab for Tolerance Evaluation

  • Research type

    Research Study

  • Full title

    Grass Pollen Sublingual Tablet Immunotherapy plus Dupilumab for Induction of Tolerance in Adults with Moderate to Severe Seasonal Allergic Rhinitis

  • IRAS ID

    275309

  • Contact name

    Stephen Durham

  • Contact email

    s.durham@imperial.ac.uk

  • Sponsor organisation

    DAIT NIAID NIH

  • Eudract number

    2018-003456-20

  • Duration of Study in the UK

    3 years, 10 months, 8 days

  • Research summary

    45 million people in Europe have allergic rhinitis (hay fever), an allergic irritation of the nasal passages caused by inhaling pollen. Hay fever impairs quality of life with reduced sleep quality, interference with daily activities and impairment of school or work performance.

    Grazax® is a medicine approved for use in the UK that stimulates the immune system to build up a tolerance to grass pollen and relieves symptoms of hay fever during the pollen season. Grazax® is a fast dissolving tablet that is placed under the tongue on a daily basis.

    Dupilumab (Dupixent®) is a treatment that is given by injection under the skin every two weeks and has been shown to be effective in patients with allergic eczema and allergic asthma as well as in patients with chronic rhinosinusitis with nasal polyps.

    In this study, participants will receive one of the following treatments for 2 years: Grazax® plus Dupilumab, Grazax® plus Dupilumab placebo (a treatment that contains no active ingredients) or Grazax® placebo plus Dupilumab placebo. Participants will not know what treatment they have been assigned to. Researchers believe that giving Grazax® and dupilumab together for 2 years will offer long-term benefits after treatment is discontinued.

    About 108 patients will be enrolled in the study. Participants will be asked to visit the clinic at least 68 times over a total duration of approximately 3 and a half years. Study procedures include physical examinations, a procedure called "nasal allergen challenge" where grass pollen extract will be sprayed inside the nose to test whether it will cause a local allergic reaction, vital signs, lung function tests, skin prick tests and questionnaires.

    Blood samples and nasal fluid/brushings will be taken before and at intervals during the study to explore the underlying biological mechanisms of long-term tolerance to grass pollen after immunotherapy.

  • REC name

    North West - Greater Manchester South Research Ethics Committee

  • REC reference

    20/NW/0089

  • Date of REC Opinion

    17 Feb 2020

  • REC opinion

    Favourable Opinion