Actively Recruiting

Phase 2
Age: 18Years - 65Years
All Genders
NCT05720325

Dupilumab Effects Against Aeroallergen Challenge

Led by The University of Texas Health Science Center at San Antonio · Updated on 2026-03-06

88

Participants Needed

2

Research Sites

239 weeks

Total Duration

On this page

Sponsors

T

The University of Texas Health Science Center at San Antonio

Lead Sponsor

N

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Dupilumab Effects Against Aeroallergen Challenge

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Understand and provide signed informed consent
  • Male or female aged 18 to 65 years at screening
  • Symptoms consistent with perennial nasal allergy for at least 2 years prior to screening
  • Positive skin prick test to D. pteronyssinus within 24 months of screening (wheal diameter at least 5 mm larger than control)
  • Asthma with documented FEV1 reversibility of at least 10% within 18 months of screening
  • Negative SARS-CoV-2 test if symptoms suggestive of COVID-19 before each HDM exposure
  • Women of childbearing potential must have negative pregnancy tests and agree to acceptable birth control methods during study and 2 months prior
  • Never smoked or ex-smoker with less than 20 pack-years and no tobacco use in past year
Not Eligible

You will not qualify if you...

  • Chronic lung disease other than asthma
  • Atopic dermatitis
  • Ocular disease not linked to allergic rhinoconjunctivitis
  • Home oxygen requirement
  • History of rebound nasal congestion or severe nasal conditions
  • FEV1 less than 70% predicted at screening
  • Unable or unwilling to withhold intranasal steroids or asthma medications as required
  • Unable or unwilling to avoid prohibited medications during screening and exposure visits
  • Use of systemic glucocorticosteroids within 1 month prior to screening
  • Use of JAK-1 inhibitors within 3 months prior to screening
  • Known allergy to dupilumab or its ingredients
  • Ongoing helminth infection
  • Recent or planned live vaccine within 30 days of screening
  • Pregnant or nursing
  • History of keratoconjunctivitis sicca
  • Indoor pet exposure causing symptoms
  • Allergen immunotherapy within 12 months of screening
  • Use of biologics other than certain anti-obesity or diabetes medications within 12 months
  • Participation in investigational drug trial within 30 days
  • Any other medical conditions or findings that increase risk or interfere with study compliance according to investigator judgment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 2 locations

1

Biogenics Research Chamber

San Antonio, Texas, United States, 78229

Actively Recruiting

2

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States, 78229

Actively Recruiting

Loading map...

Research Team

S

Sunil K Ahuja, MD

CONTACT

A

Alisha Smith, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

4

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here