RecruitingPhase 2

Dupilumab Effects Against Aeroallergen Challenge

United States88 participantsStarted 2023-03-29

Plain-language summary

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

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Will demonstrate understanding of the study and will provide a signed and dated informed consent.
✓. Will be male or female, 18 to 65 years of age at the time of the screening visit.
✓. Will have symptoms consistent with perennial nasal allergy for a minimum of 2 years prior to the screening visit.
✓. 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).
✓. Will have asthma with a documented FEV1 reversibility of ≥10% within 18 months of screening.
✓. 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.
✓. 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 a medically acceptable form of birth control throughout the study duration and for at least 2 months prior to Visit 1. Acceptable methods of birth control for this study include:
✓. oral, patch, or intra-vaginal contraceptives

✕. Have a chronic lung disease other than asthma.
✕. Have atopic dermatitis.
✕. Have any ocular disease that is not associated with allergic rhinoconjunctivitis.
✕. Are on home oxygen requirement.
✕. Have a history of rebound nasal congestion (brought on by extended use of topical decongestants), chronic rhinosinusitis with or without nasal polyps, nasal septal perforation, or severe nasal tract malformations noted on physical exam.
✕. Have FEV1 \<70% predicted as determined by pre-bronchodilator spirometry at visit 1.
✕. Are unwilling/unable to withhold intranasal steroids or asthma medications before specified visits.
✕. Are unwilling/unable to abstain from protocol-defined prohibited medications for the protocol-specified times before and during screening/selection and ACC HDM exposure visits.

Overall change in ACC HDM exposure-induced nasal airway gene expression profile

Timeframe: Baseline to 18 weeks

NCT IDNCT05720325

SponsorThe University of Texas Health Science Center at San Antonio

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-11

Sunil K Ahuja, MD

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Will demonstrate understanding of the study and will provide a signed and dated informed consent.
✓. Will be male or female, 18 to 65 years of age at the time of the screening visit.
✓. Will have symptoms consistent with perennial nasal allergy for a minimum of 2 years prior to the screening visit.
✓. 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).
✓. Will have asthma with a documented FEV1 reversibility of ≥10% within 18 months of screening.
✓. 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.
✓. 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 a medically acceptable form of birth control throughout the study duration and for at least 2 months prior to Visit 1. Acceptable methods of birth control for this study include:
✓. oral, patch, or intra-vaginal contraceptives

✕. Have a chronic lung disease other than asthma.
✕. Have atopic dermatitis.
✕. Have any ocular disease that is not associated with allergic rhinoconjunctivitis.
✕. Are on home oxygen requirement.
✕. Have a history of rebound nasal congestion (brought on by extended use of topical decongestants), chronic rhinosinusitis with or without nasal polyps, nasal septal perforation, or severe nasal tract malformations noted on physical exam.
✕. Have FEV1 \<70% predicted as determined by pre-bronchodilator spirometry at visit 1.
✕. Are unwilling/unable to withhold intranasal steroids or asthma medications before specified visits.
✕. Are unwilling/unable to abstain from protocol-defined prohibited medications for the protocol-specified times before and during screening/selection and ACC HDM exposure visits.