Actively Recruiting
Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber
Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-03-06
88
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center at San Antonio
Lead Sponsor
N
National Institute of Allergy and Infectious Diseases (NIAID)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to study adults aged 18 to 65 with allergic asthma linked to house dust mites (HDM). The trial evaluates how dupilumab, a drug targeting immune response, affects symptoms and gene expression after controlled HDM exposure in an Aeroallergen Challenge Chamber (ACC). The trial focuses on differentiating adaptive and maladaptive response types to HDM and monitors changes during treatment. Participants first undergo HDM exposure in the ACC to identify their response phenotype. Those identified with adaptive or maladaptive phenotypes are then randomly assigned to receive either dupilumab or a placebo for 18 weeks. During this period, participants continue to have HDM exposure visits in the ACC to assess how dupilumab influences their symptoms and immune response compared to placebo. Throughout the study, participants are closely monitored with symptom assessments and gene expression tests from nasal airway and blood samples. The primary outcome is the change in nasal airway gene expression from baseline to 18 weeks. Additional measures include symptom scoring and blood gene expression changes. Safety and adherence are tracked regularly, with all procedures and exposures carefully controlled over the course of the trial.
CONDITIONS
Brief Title
Dupilumab Effects Against Aeroallergen Challenge
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understands the study and provides signed informed consent
- Male or female, aged 18 to 65 at screening
- Has perennial nasal allergy symptoms for at least 2 years
- Positive skin prick test to Dermatophagoides pteronyssinus within 24 months
- Asthma with documented FEV1 reversibility of 10% or more within 18 months
- Negative COVID-19 test before each allergen exposure if symptoms present
- Women of childbearing potential must have negative pregnancy tests and agree to acceptable birth control methods during the study
- Never smoked or ex-smoker with less than 20 pack years and no tobacco use in past year
You will not qualify if you...
- Chronic lung diseases other than asthma
- Atopic dermatitis
- Ocular diseases unrelated to allergic rhinoconjunctivitis
- Home oxygen requirement
- History of rebound nasal congestion from extended decongestant use, chronic rhinosinusitis, nasal polyps, septal perforation, or severe nasal malformations
- FEV1 less than 70% predicted at screening
- Unwilling or unable to withhold intranasal steroids or asthma medications as required
- Use of prohibited medications before or during study visits
- Use of systemic glucocorticosteroids within 1 month prior to screening
- Use of JAK-1 inhibitors within 3 months prior to screening
- Known allergy to dupilumab or its ingredients
- Ongoing helminth infection
- Live vaccine within 30 days before screening or planned during study
- Pregnant or nursing
- History of keratoconjunctivitis sicca
- Exposure to indoor pets causing symptoms
- Allergen immunotherapy within 12 months
- Use of biologics other than anti-obesity or diabetes meds within 12 months
- Participation in another investigational drug trial within 30 days
- Other medical issues posing risk or interfering with study compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 18 weeks
Participants receive dupilumab or placebo and are exposed to house dust mites in the Aeroallergen Challenge Chamber to assess symptom severity and gene expression changes.
Multiple visits for aeroallergen challenges and assessments during treatment
Trial Site Locations
Total: 2 locations
1
Biogenics Research Chamber
San Antonio, Texas, United States, 78229
Actively Recruiting
2
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
S
Sunil K Ahuja, MD
A
Alisha Smith, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
4
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