NCT05720325

Dupilumab Effects Against Aeroallergen Challenge

Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Asthma, Allergic

Interventions

Type	Name	Description
DRUG	Dupilumab	Dupixent is an interleukin-4 receptor alpha antagonist
OTHER	House Dust Mites (HDM)	House Dust Mites used to challenge subjects using an aeroallergen challenge chamber
OTHER	Placebo	Inert placebo administered to placebo arms of study.

Timeline

• Start date: 2023-03-29
• Primary completion: 2026-11-01
• Completion: 2027-11-01
• First posted: 2023-02-09
• Last updated: 2026-03-06

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study