NCT05720325 Dupilumab Effects Against Aeroallergen Challenge
| NCT ID | NCT05720325 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | The University of Texas Health Science Center at San Antonio |
| Condition | Asthma, Allergic |
| Study Type | INTERVENTIONAL |
| Enrollment | 88 participants |
| Start Date | 2023-03-29 |
| Primary Completion | 2026-11 |
Trial Parameters
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Brief Summary
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
Eligibility Criteria
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 of ≥10% within 18 months of screening. 6. If a participant manifests symptoms suggestive of COVID-19, the participant must have a negative SARS-CoV-2 rapid antigen nasopharyngeal swab test before each HDM exposure visit. 7. A woman of childbearing potential, must have a negative urine pregnancy test at Visit 1 and prior to each exposure in the ACC. All women of childbearing potential must agree to
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