RECRUITING

Dupilumab Effects Against Aeroallergen Challenge

Conditions

Asthma, Allergic House Dust Mite Allergy Asthma Aeroallergen chamber Dupilumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2023-03-29

Study Completion:2027-11

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05720325

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 12 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) 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).	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. 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.

Inclusion Criteria

Exclusion 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 12 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)
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).

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.
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.

Contacts and Locations

Study Contact

Sunil K Ahuja, MD

CONTACT

210-567-4823

ahujas@uthscsa.edu

Alisha Smith, PhD

CONTACT

210-567-3709

Smitha22@uthscsa.edu

Principal Investigator

Sunil K Ahuja, MD

PRINCIPAL_INVESTIGATOR

University of Texas Health Science Center San Antonio

Study Locations (Sites)

Biogenics Research Chamber

San Antonio, Texas, 78229

United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229

United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center at San Antonio

Sunil K Ahuja, MD, PRINCIPAL_INVESTIGATOR, University of Texas Health Science Center San Antonio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-29

Study Completion Date2027-11

Study Record Updates

Study Start Date2023-03-29

Study Completion Date2027-11

Terms related to this study

Keywords Provided by Researchers

House Dust Mite Allergy
Asthma
Aeroallergen chamber
Dupilumab

Additional Relevant MeSH Terms

Asthma, Allergic