Asthma, AllergicPhase 2NCT05720325
Dupilumab Effects Against Aeroallergen Challenge
A Phase 2 study testing Dupilumab and House Dust Mites (HDM) in people with Asthma, Allergic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
Trial summary
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma, Allergic
- What is being tested?
- Dupilumab and House Dust Mites (HDM)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Mar 2023to 1 Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
- Norplant System® or other implant system
- Depo-Provera®
- IUD
- double barrier method
- abstinence
- 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.
- 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 cannot join
- 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.
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- 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.
- Have received any oral or other form of systemic glucocorticosteroids within 1 month prior to the screening visit.
- Have received JAK-1 inhibitors within 3 months prior to the screening visit.
- Have known hypersensitivity to dupilumab or any of its excipients.
- Have an ongoing helminth infection.
- 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)
- Are pregnant or nursing.
- Have a history of keratoconjunctivitis sicca.
- Have indoor pet exposure causing upper or lower symptoms.
- Have received allergen immunotherapy of any form within 12 months of screening visit.
- Received biologics, other than anti-obesity or diabetes medications (such as tirzepatides, semaglutides), for any indication within 12 months of screening visit.
- Have participated in a trial with an investigational drug in the past 30 days.
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Biogenics Research Chamber
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
Read the detailed description
(i)Intervention #1: HDM exposures in the ACC This trial utilizes exposures to House dust mites (HDM) in the Aeroallergen Challenge Chamber (ACC) as a two-pronged tool for (i) precision phenotyping of HDM+PARC+AA+ persons to identify those with the adaptive and maladaptive phenotypes and (ii) assessment of symptoms intermittently throughout the clinical trial to monitor effects of dupilumab/placebo on symptom severity .
(ii) Participants classifying to the adaptive and maladaptive phenotypes are then randomized to 18-weeks dupilumab vs. placebo, with ACC HDM visits during this phase.
- Conditions
- Asthma, Allergic
- Being tested
- Dupilumab, House Dust Mites (HDM), Placebo
- Keywords
- House Dust Mite Allergy, Asthma, Aeroallergen chamber, Dupilumab
- Medical subject headings
- Asthma, Dust Mite Allergy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DupilumabDrug
Also called Dupixent
Dupixent is an interleukin-4 receptor alpha antagonist
House Dust Mites (HDM)Other
House Dust Mites used to challenge subjects using an aeroallergen challenge chamber
PlaceboOther
Also called Placebo for Dupixent
Inert placebo administered to placebo arms of study.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Phenotypes randomized to study drug | Active comparator | This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug. Receives: Drug: Dupilumab; Other: House Dust Mites (HDM) |
| Maladaptive Phenotypes randomized to study drug | Experimental | This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug. Receives: Drug: Dupilumab; Other: House Dust Mites (HDM) |
| Adaptive Phenotype randomized to placebo | Placebo comparator | This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo. Receives: Other: House Dust Mites (HDM); Other: Placebo |
| Maladaptive Phenotype randomized to placebo | Placebo comparator | This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo. Receives: Other: House Dust Mites (HDM); Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall change in ACC HDM exposure-induced nasal airway gene expression profile
The overall (longitudinal) change in the ACC HDM exposure-induced nasal airway gene expression profiles observed during the first HDM exposure (visit 3; pre-randomization) and during the three on-treatment HDM exposures (visits 7, 11, and 15)
Measured: Baseline to 18 weeks
Secondary outcomes (2)
Overall change in ACC HDM during first HDM exposure-induced peripheral blood gene expression
The overall (longitudinal) change in the ACC HDM exposure-induced peripheral blood gene expression profiles observed during the first HDM exposure (Visit 3; pre-randomization) and during the three on-treatment HDM exposures (visits 7, 11, and 15).
Measured: Baseline to 18 weeks
Average symptom scores (Instantaneous Summated Symptom Score-Average: iSSS-AV)
The change in the average symptom scores (iSSS-AV - average of the 10 instantaneous symptom score recordings obtained at 30-minute intervals, from t=30 min to t=300 min, throughout the 5-hour HDM exposure) assessed during the first HDM exposure (Visit 3; pre-randomization) and across the three on-treatment HDM exposures (visits 7, 11, and 15).
Summated Symptom Score (SSS) scoring system Symptom Score range TNSS (Total Nasal Symptom score) 0-12 Rhinorrhea(1) 0-3 Congestion(1) 0-3 Sneezing(1) 0-3 Nasal itching(1) 0-3
TOSS (Total Ocular Symptom Score) 0-9 Ocular redness(2) 0-3 Tearing(2) 0-3 Ocular itching(2) 0-3
TASS (Total Asthma Symptom Score) 0-9 Cough(3) 0-3 Wheeze(3) 0-3 Dyspnea(3) 0-3 Summated symptom score (SSS) = TNSS + TOSS + TASS 0-30
(1),(2),(3)Scored on a Likert-scale of 0=absent, 1=mild, 2=moderate, 3=severe Component of (1)TNSS, (2)TOSS, (3)TASS
Measured: Baseline to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start29 Mar 2023
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma, AllergicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, double-blind, randomized placebo-controlled mechanistic clinical trial to test the effects of an 18-week course of dupilumab on HDM allergen challenge-induced nasal mucosa and peripheral blood traits and symptoms in persons with HDM-associated perennial allergic rhinoconjunctivitis (PARC) with allergic asthma (HDM+PARC+AA+) participants. For each yearly cohort, participants of each phenotype will be randomly selected, resulting in two groups classified as the (i) adaptive, and (ii) maladaptive phenotypes. Using the R package SeqAlloc, a covariate-adjusted randomization will be employed to randomize each of these two groups into two subgroups; the subgroups within each group (phenotype) will be balanced by age and gender. Thus, this will result in the generation of four groups: (i) adaptive-A (ii) adaptive-B (iii) maladaptive-A (iv) maladaptive-B
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Sunil Ahuja, The University of Texas Health Science Center at San Antonio
- Investigators
- Sunil K Ahuja, MD, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720325
- Sponsor's protocol ID
- HSC20220665H
- Other IDs
- 1U01AI158460-01A1
- Status last verified
- Jun 2026
- First submitted
- 27 Jan 2023
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The PI is dedicated to support free exchange of relevant scientific information. The PI agrees to keep all information and results concerning the study and the investigational product confidential as long as the data remain unpublished or have not been presented at a public meeting/conference. The PI also assures that the key design elements of this protocol will be posted in clinicaltrials.gov. Prior to any submission, all manuscripts/abstracts may be presented to Regeneron for review. Before the clinical trial commences, the PI will discuss authorship with the study team. The published international guidelines for authorship (International Committee of Medical Journal Editors, 1997) will be adhered to; i.e., "All persons designated as authors should qualify for authorship. Each author should have participated sufficiently in the work to take public responsibility for the content."
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber
- ClinicalTrials.gov ID
- NCT05720325
- Acronym / sponsor ID
- HSC20220665H
- Conditions
- Asthma, Allergic
- Keywords
- House Dust Mite Allergy, Asthma, Aeroallergen chamber, Dupilumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 96 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Regeneron Pharmaceuticals
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The trial involves two interventions: (i) exposure to HDM in the ACC and (ii) administration of dupilumab/placebo for dupilumab.
Detailed description
(i)Intervention #1: HDM exposures in the ACC This trial utilizes exposures to House dust mites (HDM) in the Aeroallergen Challenge Chamber (ACC) as a two-pronged tool for (i) precision phenotyping of HDM+PARC+AA+ persons to identify those with the adaptive and maladaptive phenotypes and (ii) assessment of symptoms intermittently throughout the clinical trial to monitor effects of dupilumab/placebo on symptom severity .
(ii) Participants classifying to the adaptive and maladaptive phenotypes are then randomized to 18-weeks dupilumab vs. placebo, with ACC HDM visits during this phase.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- This is a prospective, double-blind, randomized placebo-controlled mechanistic clinical trial to test the effects of an 18-week course of dupilumab on HDM allergen challenge-induced nasal mucosa and peripheral blood traits and symptoms in persons with HDM-associated perennial allergic rhinoconjunctivitis (PARC) with allergic asthma (HDM+PARC+AA+) participants. For each yearly cohort, participants of each phenotype will be randomly selected, resulting in two groups classified as the (i) adaptive, and (ii) maladaptive phenotypes. Using the R package SeqAlloc, a covariate-adjusted randomization will be employed to randomize each of these two groups into two subgroups; the subgroups within each group (phenotype) will be balanced by age and gender. Thus, this will result in the generation of four groups: (i) adaptive-A (ii) adaptive-B (iii) maladaptive-A (iv) maladaptive-B
| Arm | Type | Receives |
|---|---|---|
| Adaptive Phenotypes randomized to study drug | Active comparator | Drug: Dupilumab, Other: House Dust Mites (HDM)This group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the study drug. |
| Maladaptive Phenotypes randomized to study drug | Experimental | Drug: Dupilumab, Other: House Dust Mites (HDM)This group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the study drug. |
| Adaptive Phenotype randomized to placebo | Placebo comparator | Other: House Dust Mites (HDM), Other: PlaceboThis group will be comprised of the Adaptive-A and Adaptive-B subgroup and will consist of the adaptive phenotype participants identified during the initial HDM ACC challenge, administered the placebo. |
| Maladaptive Phenotype randomized to placebo | Placebo comparator | Other: House Dust Mites (HDM), Other: PlaceboThis group will be comprised of the Maladaptive-A and Maladaptive-B subgroup and will consist of the maladaptive phenotype participants identified during the initial HDM ACC challenge administered the placebo. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DupilumabAlso: DupixentDupixent is an interleukin-4 receptor alpha antagonist | Drug | Adaptive Phenotypes randomized to study drug, Maladaptive Phenotypes randomized to study drug |
| House Dust Mites (HDM)House Dust Mites used to challenge subjects using an aeroallergen challenge chamber | Other | Adaptive Phenotype randomized to placebo, Adaptive Phenotypes randomized to study drug, Maladaptive Phenotype randomized to placebo, Maladaptive Phenotypes randomized to study drug |
| PlaceboAlso: Placebo for DupixentInert placebo administered to placebo arms of study. | Other | Adaptive Phenotype randomized to placebo, Maladaptive Phenotype randomized to placebo |
Primary outcome
Overall change in ACC HDM exposure-induced nasal airway gene expression profile
Time frame: Baseline to 18 weeks
The overall (longitudinal) change in the ACC HDM exposure-induced nasal airway gene expression profiles observed during the first HDM exposure (visit 3; pre-randomization) and during the three on-treatment HDM exposures (visits 7, 11, and 15)
2 secondary outcomes
Overall change in ACC HDM during first HDM exposure-induced peripheral blood gene expression
Time frame: Baseline to 18 weeks
Average symptom scores (Instantaneous Summated Symptom Score-Average: iSSS-AV)
Time frame: Baseline to 18 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Yes. The PI is dedicated to support free exchange of relevant scientific information. The PI agrees to keep all information and results concerning the study and the investigational product confidential as long as the data remain unpublished or have not been presented at a public meeting/conference. The PI also assures that the key design elements of this protocol will be posted in clinicaltrials.gov. Prior to any submission, all manuscripts/abstracts may be presented to Regeneron for review. Before the clinical trial commences, the PI will discuss authorship with the study team. The published international guidelines for authorship (International Committee of Medical Journal Editors, 1997) will be adhered to; i.e., "All persons designated as authors should qualify for authorship. Each author should have participated sufficiently in the work to take public responsibility for the content."
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunil K Ahuja, MD principal investigator
The University of Texas Health Science Center at San Antonio
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dupilumab and House Dust Mites (HDM) in people with Asthma, Allergic, run by The University of Texas Health Science Center at San Antonio at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall change in ACC HDM exposure-induced nasal airway gene expression profile (time frame: Baseline to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.