Grass Pollen Immunotherapy plus Dupilumab for Tolerance Induction.

Phase 1

• Conditions: Moderate to Severe Seasonal Allergic Rhinitis; MedDRA version: 20.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004870; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2018-003456-20-GB
• Lead Sponsor: Division of Allergy, Immunology, and Transplantation; National Institute of Allergy and Infectious Disease

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-11-15
• Last Update Posted: 23 March 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 108

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).

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.
8.History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
9.History of systemic disease affecting the immune system such as autoimmune diseases, immune complex disease or immunodeficiency.
10.At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified