Dupilumab Effects Against Aeroallergen Challenge

• Status: Not yet recruiting
• Trial end date: 2027-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Regeneron Pharmaceuticals
• Treatments: Antibodies, Monoclonal

Criteria

Inclusion Criteria:

1. Will demonstrate understanding of the study and will provide a signed and dated informed consent.

2. Will be male or female, 18 to 65 years of age at the time of the screening visit.

3. Will be vaccinated with at least one primary COVID-19 vaccination and at least one booster and/or will provide proof of infection with COVID-19 in the last 6 months.

4. Will have symptoms consistent with perennial nasal allergy for a minimum of 2 years prior to the screening visit.

5. Will have a positive standard skin prick test (SPT) to D. pteronyssinus within the past 12 months. A positive SPT is defined as a wheal diameter of at least 5 mm larger than the negative control (normal saline).

6. Will have asthma with a documented reversibility of FEV1 of ≥10% within the past 12 months and an Asthma Control Questionnaire-7 (ACQ-7) Score of ≥1.0 at selection visit.

7. Will have a negative SARS-CoV-2 rapid antigen nasopharyngeal swab test before each HDM exposure visit. Note: Participation of individuals who pass eligibility criteria but are disqualified due to a positive SARS-CoV2 test and/or COVID-19 questionnaire will be deferred for the following study year.

8. Will not display COVID-19 symptoms, based on a questionnaire before each HDM exposure visit.

9. A woman of childbearing potential, must have a negative urine pregnancy test at Visit 1 and prior to each exposure in the ACC. All women of childbearing potential must agree to a medically acceptable form of birth control throughout the study duration and for at least 2 months prior to Visit 1. Acceptable methods of birth control for this study include:

1. oral, patch, or intra-vaginal contraceptives

2. Norplant System®

3. Depo-Provera®

4. Intrauterine device (IUD)

5. double barrier method

6. abstinence

7. surgical sterility (hysterectomy or tubal ligation) Women who are at least 1-year post-menopausal qualify as non-childbearing for this study.

10. Will have never smoked or will be an ex-smoker (<20 packs years and no cigarette or smokeless tobacco use in the past year).

Exclusion Criteria:

1. Have a chronic lung disease other than asthma.

2. Have atopic dermatitis

3. Have any ocular disease that is not associated with allergic rhinoconjunctivitis

4. Are on home oxygen requirement.

5. Have a history of rebound nasal congestion (brought on by extended use of topical decongestants), chronic rhinosinusitis with or without nasal polyps, nasal septal perforation, or severe nasal tract malformations noted on physical exam.

6. Have Forced Expiratory volume/Forced vital capacity (FEV1/ FVC) of <70% predicted as determined by baseline pre-bronchodilator spirometry.

7. Are unwilling/unable to withhold intranasal steroids or asthma medications before specified visits.

8. Are unwilling/unable to abstain from protocol-defined prohibited medications for the protocol-specified times before and during screening/selection and ACC HDM exposure visits.

9. Have received any oral or other form of systemic glucocorticosteroids within 1 month prior to the screening visit.

10. Have received Janus kinase-1 (JAK-1) inhibitors within 3 months prior to the screening visit.

11. Have known hypersensitivity to dupilumab or any of its excipients.

12. Have an ongoing helminth infection.

13. Have received a live vaccine within 30 days of screening or are planned to receive one during study participation.

14. Are pregnant or nursing.

15. Have a history of keratoconjunctivitis sicca.

16. Have indoor pet exposure causing upper or lower symptoms.

17. Have received allergen immunotherapy of any form within 12 months of screening visit.

18. Have received biologics for any indication within 12 months of screening visit.

19. Have participated in a trial with an investigational drug in the past 6 months.

20. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, that, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.