Recruiting

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

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What is being tested

Dupilumab

+ House Dust Mites (HDM)

+ Placebo

DrugOther
Who is being recruted

Dust Mite Allergy+12

+ Asthma

+ Bronchial Diseases

From 18 to 65 Years
See all eligibility criteria
How is the trial designed

Basic Science Study

Placebo-ControlledPhase 2
Interventional
Study Start: March 2023
See protocol details

Summary

Principal SponsorThe University of Texas Health Science Center at San Antonio
Study ContactSunil K Ahuja, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 29, 2023

Actual date on which the first participant was enrolled.

(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.

Official TitleMechanistic Trial of Dupilumab in Adults With House Dust Mite-associated Asthma Using an Aeroallergen Challenge Chamber
NCT05720325
Principal SponsorThe University of Texas Health Science Center at San Antonio
Study ContactSunil K Ahuja, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

88 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Basic Science Study

Basic science studies help researchers understand how the body works or how a disease develops. They don't test treatments, but they build the foundation for future therapies.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Dust Mite AllergyAsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveNose DiseasesOtorhinolaryngologic DiseasesRespiratory HypersensitivityRespiratory Tract DiseasesRhinitisRhinitis, Allergic, PerennialRhinitis, Allergic

Criteria

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. Have received biologics, 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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

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.

Group II

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.

Group III

Placebo
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.

Group IV

Placebo
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Biogenics Research Chamber

San Antonio, United StatesOpen Biogenics Research Chamber in Google Maps
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University of Texas Health Science Center at San Antonio

San Antonio, United States
Recruiting
2 Study Centers