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 — DRUGDupixent is an interleukin-4 receptor alpha antagonist
- House Dust Mites (HDM) — OTHERHouse Dust Mites used to challenge subjects using an aeroallergen challenge chamber
- Placebo — OTHERInert 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 drugThis 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 drugThis 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 placeboThis 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 placeboThis 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
- Sunil K Ahuja, MD210-567-4823
- Alisha Smith, PhD210-567-3709
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Biogenics Research Chamber | San Antonio | Texas | 78229 | Robert L Jacobs, MD |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78229 | - |