Dupilumab Effects Against Aeroallergen Challenge (NCT05720325) | Clinical Trial Compass
Active — Not 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is specifically studying how dupilumab affects gene expression in the nasal airways after exposure to house dust mite allergens — is that kind of allergen challenge test something I'd be comfortable doing, and what does it actually involve?
2Since this is a Phase 2 trial, the researchers are still building evidence about how dupilumab works in allergic asthma at the biological level — does that mean there's still uncertainty about the risks or benefits compared to treatments I could start right now?
3The trial is no longer enrolling new participants, so I can't join it — but based on what this study is trying to learn about dupilumab and house dust mite allergy, is dupilumab something worth discussing as a treatment option for my type of asthma?
4This study is measuring changes in nasal airway gene expression, which is a pretty specialized biological marker — can you help me understand what that actually tells us about whether dupilumab might help control my asthma symptoms day-to-day?
5If house dust mite is one of my known triggers, are there other ongoing studies or approved treatments targeting that specific allergen pathway that my care team thinks I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.