Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber
The University of Texas Health Science Center at San Antonio
Summary
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
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 have symptoms consistent with perennial nasal allergy for a minimum of 2 years prior to the screening visit. 4. Will have a positive standard skin prick test (SPT) to D. pteronyssinus within 24 months of screening. A positive SPT is defined as a wheal diameter of at least 5 mm larger than the negative control (normal saline). 5. Will have asthma with a documented FEV1 reversibility…
Interventions
- DrugDupilumab
Dupixent is an interleukin-4 receptor alpha antagonist
- OtherHouse Dust Mites (HDM)
House Dust Mites used to challenge subjects using an aeroallergen challenge chamber
- OtherPlacebo
Inert placebo administered to placebo arms of study.
Locations (2)
- Biogenics Research ChamberSan Antonio, Texas
- University of Texas Health Science Center at San AntonioSan Antonio, Texas