Dupilumab Effects Against Aeroallergen Challenge

Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber

Dupilumab Effects Against Aeroallergen Challenge (NCT05720325) is a Phase 2 interventional studying Asthma, Allergic, sponsored by The University of Texas Health Science Center at San Antonio. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Asthma, Allergic and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 88 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Asthma, Allergic subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Will demonstrate understanding of the study and will provide a signed and dated willing to sign a consent form. 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). Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Dupilumab

Dupixent is an interleukin-4 receptor alpha antagonist

OTHER

House Dust Mites (HDM)

House Dust Mites used to challenge subjects using an aeroallergen challenge chamber

OTHER

Placebo

Inert placebo administered to placebo arms of study.

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Biogenics Research Chamber

San Antonio, Texas, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05720325), the sponsor (The University of Texas Health Science Center at San Antonio), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05720325 clinical trial studying?

The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT05720325?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05720325?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05720325. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05720325. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.