Dupilumab Effects Against Aeroallergen Challenge

NCT05720325 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HSC20220665H1U01AI158460-01A1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Asthma, Allergic

Keywords

House Dust Mite Allergy; Asthma; Aeroallergen chamber; Dupilumab

Outcome Measures

Primary Outcomes (1)

• 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)

  Baseline to 18 weeks

Secondary Outcomes (2)

• Overall change in ACC HDM during first HDM exposure-induced peripheral blood gene expression

  Baseline to 18 weeks

• Average symptom scores (Instantaneous Summated Symptom Score-Average: iSSS-AV)

  Baseline to 18 weeks

Study Arms (4)

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.

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.

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.

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.

Other: House Dust Mites (HDM); Other: Placebo

Interventions

Dupilumab DRUG

Dupixent is an interleukin-4 receptor alpha antagonist

Also known as: Dupixent

Adaptive Phenotypes randomized to study drug; Maladaptive Phenotypes randomized to study drug

House Dust Mites (HDM) OTHER

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

Adaptive Phenotype randomized to placebo; Adaptive Phenotypes randomized to study drug; Maladaptive Phenotype randomized to placebo; Maladaptive Phenotypes randomized to study drug

Placebo OTHER

Inert placebo administered to placebo arms of study.

Also known as: Placebo for Dupixent

Adaptive Phenotype randomized to placebo; Maladaptive Phenotype randomized to placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Regeneron Pharmaceuticals: collaborator
• The University of Texas Health Science Center at San Antonio: lead

Study Sites (2)

Biogenics Research Chamber

San Antonio, Texas, 78229, United States

RECRUITING

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Asthma; Dust Mite Allergy

Interventions

dupilumab; Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Sunil K Ahuja, MD

  The University of Texas Health Science Center at San Antonio

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunil K Ahuja, MD

CONTACT

210-567-4823; ahujas@uthscsa.edu

Alisha Smith, PhD

CONTACT

210-567-3709; Smitha22@uthscsa.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The designated unblinded biostatisticians will allocate dupilumab or placebo for dupilumab to each participant. The designated unblinded biostatisticians will develop the final unblinded randomization key for coding of study drug that will be filed in a secure location in the event that unblinding is necessary at any point during the study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 9, 2023
• Study Start: March 29, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: At the time of publication in a peer reviewed journal.

Locations

US (2)