Dupilumab Effects Against Aeroallergen Challenge

Part of paid clinical trials in San Antonio, Texas.

Sponsor
The University of Texas Health Science Center at San Antonio
Study ID
NCT05720325
Phase
PHASE2
Status
Recruiting

Conditions

  • Asthma, Allergic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Mar 29, 2023
Status verified
Mar 2026
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
88 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Adaptive Phenotypes randomized to study drug
    This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug.
  • Experimental: Maladaptive Phenotypes randomized to study drug
    This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug.
  • Placebo Comparator: Adaptive Phenotype randomized to placebo
    This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo.
  • Placebo Comparator: Maladaptive Phenotype randomized to placebo
    This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo.

Primary Outcome Measure

Overall change in ACC HDM exposure-induced nasal airway gene expression profile [ Time Frame: Baseline to 18 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Biogenics Research ChamberSan AntonioTexas78229
Robert L Jacobs, MD
Sunil K Ahuja, MD
210-567-4823
University of Texas Health Science Center at San AntonioSan AntonioTexas78229-

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