Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction (NCT04502966) | Clinical Trial Compass
CompletedPhase 2
Grass Pollen Immunotherapy Plus Dupilumab for Tolerance Induction
United Kingdom199 participantsStarted 2020-11-05
Plain-language summary
The primary objective of this study is to assess whether the combination of grass allergen sublingual immunotherapy (SLIT) and dupilumab for 2 years is more effective than double placebo in suppressing the nasal allergen challenge (NAC) response to grass pollen at 1 year after completion of study medication.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Participant must be able to understand and provide informed consent
* A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years, with peak symptoms in May, June, or July
* A clinical history of moderate to severe rhinoconjunctivitis symptoms for at least 2 years, interfering with usual daily activities or with sleep as defined according to the Allergic Rhinitis and Its Impact on Asthma (ARIA) classification of rhinitis
* A clinical history of inadequately controlled rhinoconjunctivitis symptoms, despite treatment with antihistamines and/or nasal corticosteroids during the grass pollen season, for at least 2 years
* Positive skin prick test response at screening, defined as wheal diameter ≥3 mm to Phleum pratense
* Positive specific immunoglobulin E (IgE) at screening, defined as IgE class 2 (e.g., ≥ 0.7 kilounits per liter \[kU/L\]) against Phleum pratense
* A woman of childbearing potential (WOCBP), regardless of birth control history, must:
* have a negative serum pregnancy test at screening,
* not be breast-feeding or lactating, and ---is required to consistently use one of the following highly effective methods of contraception throughout the study:
* hormonal (e.g. oral, transdermal, intravaginal, implant, or injection),
* intrauterine device (IUD) or system (IUS),
* vasectomized partner,
* bilateral tubal occlusion, or
* sexual abstinence.
Exclusion Criteria:
* Inability or unwillingne…
What they're measuring
1
TNSS Area Under Curve (AUC) Post Nasal Allergen Challenge (NAC) Over the First Hour After the Challenge (0-1 Hour (hr) at Year 3
Timeframe: 0 to 1 hour of the NAC at Year 3 (One Year After Completion of Treatment)
Trial details
NCT IDNCT04502966
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)