Dupilumab Effects Against Aeroallergen Challenge

Last updated: March 4, 2026
Sponsor: The University of Texas Health Science Center at San Antonio
Overall Status: Active - Recruiting

Phase

2

Condition

Asthma

Treatment

House Dust Mites (HDM)

Dupilumab

Placebo

Clinical Study ID

NCT05720325
HSC20220665H
1U01AI158460-01A1
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

  3. Will have symptoms consistent with perennial nasal allergy for a minimum of 2 yearsprior to the screening visit.

  4. Will have a positive standard skin prick test (SPT) to D. pteronyssinus within 24months of screening. A positive SPT is defined as a wheal diameter of at least 5 mmlarger than the negative control (normal saline).

  5. Will have asthma with a documented FEV1 reversibility of ≥10% within 18 months ofscreening.

  6. If a participant manifests symptoms suggestive of COVID-19, the participant musthave a negative SARS-CoV-2 rapid antigen nasopharyngeal swab test before each HDMexposure visit.

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

  8. oral, patch, or intra-vaginal contraceptives

  9. Norplant System® or other implant system

  10. Depo-Provera®

  11. IUD

  12. double barrier method

  13. abstinence

  14. surgical sterility (hysterectomy, tubal ligation, or uterine ablation) Post-menopausal women defined as women without a menstrual cycle for at least 12consecutive months qualify as non-childbearing for this study.

  15. Will have never smoked or will be an ex-smoker (<20 pack year history and nocigarette or smokeless tobacco use in the past year).

Exclusion

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 topicaldecongestants), chronic rhinosinusitis with or without nasal polyps, nasal septalperforation, or severe nasal tract malformations noted on physical exam.

  6. Have FEV1 <70% predicted as determined by pre-bronchodilator spirometry at visit 1.

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

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

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

  10. Have received 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 receiveone during study participation.Note: Participant can receive a live vaccine > 30days after final study investigational product injection (visit 14)

  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 screeningvisit.

  18. Received biologics, other than anti-obesity or diabetes medications (such astirzepatides, semaglutides), for any indication within 12 months of screening visit.

  19. Have participated in a trial with an investigational drug in the past 30 days.

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

Study Design

Total Participants: 88
Treatment Group(s): 3
Primary Treatment: House Dust Mites (HDM)
Phase: 2
Study Start date:
March 29, 2023
Estimated Completion Date:
November 30, 2027

Study Description

(i)Intervention #1: HDM exposures in the ACC This trial utilizes exposures to House dust mites (HDM) in the Aeroallergen Challenge Chamber (ACC) as a two-pronged tool for (i) precision phenotyping of HDM+PARC+AA+ persons to identify those with the adaptive and maladaptive phenotypes and (ii) assessment of symptoms intermittently throughout the clinical trial to monitor effects of dupilumab/placebo on symptom severity .

(ii) Participants classifying to the adaptive and maladaptive phenotypes are then randomized to 18-weeks dupilumab vs. placebo, with ACC HDM visits during this phase.

Connect with a study center

  • Biogenics Research Chamber

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas 78229
    United States

    Active - Recruiting

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