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

Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease0 sites108 target enrollmentNovember 15, 2019

DrugsGRAZAX 75,000 SQ-T oral lyophilisate Dupixent

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease
Enrollment: 108
Status: Active, not recruiting
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 15, 2019

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease

Eligibility Criteria

Inclusion Criteria

•Individuals who meet all of the following criteria are eligible for enrollment as study participants:
•1\.Participant must be able to understand and provide informed consent.
•2\.Adults age 18 to 65 years.
•3\.A clinical history of grass pollen\-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July.
•4\.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.
•5\.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.
•6\.Positive skin prick test response at screening, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense.
•7\.Positive specific IgE at screening, defined as greater than or equal to IgE class 2 (0\.7 kU/L) against Phleum pratense.
•8\. A positive response to NAC with Phleum pratense defined as a TNSS greater than or equal to 5 of 12 points.
•9\.Female participants of childbearing potential, regardless of birth control history, must have a negative serum pregnancy test at screening, must not be breast\-feeding or lactating, and are 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); double barrier (i.e., latex condom, diaphragm with spermicide); intrauterine device (IUD) or system (IUS); vasectomized partner (6 months minimum); or bilateral tubal ligation (if no conception post\-procedure).

Exclusion Criteria

•Individuals who meet any of these criteria are not eligible for enrollment as study participants:
•1\.Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
•2\.Prebronchodilator forced expiratory volume (FEV1\) less than 70% of predicted value at either screening or baseline visit.
•3\.A clinical history of asthma requiring regular inhaled corticosteroids for \> 4 weeks per year outside of the grass pollen season.
•4\.A clinical history of moderate to severe allergic rhinitis, as defined according to the ARIA classification of rhinitis, caused by either:
•a.an allergen to which the participant is regularly exposed OR
•b.tree pollen during tree pollen season treated with regular antihistamine or intranasal corticosteroids.
•5\.History of emergency visit or hospital admission for asthma in the previous 12 months.
•6\.History of chronic obstructive pulmonary disease.
•7\.History of recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.