Dust mite asthma study aims to uncover how dupilumab works inside the body
NCT ID NCT05720325
First seen Jun 27, 2026 · Last updated Aug 12, 2026 · Updated 2 times
Summary
This study looks at how dupilumab changes the way the nose and blood respond to house dust mites in adults with allergic asthma. Participants will be exposed to dust mites in a special chamber and receive either dupilumab or a placebo. The goal is to understand the drug's effects on gene activity, not to directly treat symptoms.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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96 people
The number who actually took part.
- Started
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Mar 2023
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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: 1. oral, patch, or intra-vaginal contraceptives 2. Norplant System® or other implant system 3. Depo-Provera® 4. IUD 5. double barrier method 6. abstinence 7. surgical sterility (hysterectomy, tubal ligation, or uterine ablation) Post-menopausal women defined as women without a menstrual cycle for at least 12 consecutive months qualify as non-childbearing for this study. 8. Will have never smoked or will be an ex-smoker (\<20 pack year history and no cigarette or smokeless tobacco use in the past year). Exclusion Criteria: 1. Have a chronic lung disease other than asthma. 2. Have atopic dermatitis. 3. Have any ocular disease that is not associated with allergic rhinoconjunctivitis. 4. Are on home oxygen requirement. 5. 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. 6. Have FEV1 \<70% predicted as determined by pre-bronchodilator spirometry at visit 1. 7. Are unwilling/unable to withhold intranasal steroids or asthma medications before specified visits. 8. 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. 9. Have received any oral or other form of systemic glucocorticosteroids within 1 month prior to the screening visit. 10. Have received JAK-1 inhibitors within 3 months prior to the screening visit. 11. Have known hypersensitivity to dupilumab or any of its excipients. 12. Have an ongoing helminth infection. 13. Have received a live vaccine within 30 days of screening or are planned to receive one during study participation.Note: Participant can receive a live vaccine \> 30 days after final study investigational product injection (visit 14) 14. Are pregnant or nursing. 15. Have a history of keratoconjunctivitis sicca. 16. Have indoor pet exposure causing upper or lower symptoms. 17. Have received allergen immunotherapy of any form within 12 months of screening visit. 18. Received biologics, other than anti-obesity or diabetes medications (such as tirzepatides, semaglutides), for any indication within 12 months of screening visit. 19. Have participated in a trial with an investigational drug in the past 30 days. 20. Have past or current medical problems or findings from physical examination or laboratory testing that are not listed above, that, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements, or may impact the quality or interpretation of the data obtained from the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Biogenics Research Chamber
San Antonio, Texas, 78229, United States
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University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
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