Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
University of California, San Diego
Study ID
NCT06385236
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Moderate to Severe Asthma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — BIOLOGICAL
    Dupilumab, an interleukin-4 receptor treatment, will be administered through a subcutaneous injection, the initial dose of 600 mg will be administered at two different injection sites (300 mg per injection), followed by a single dose of 300 mg administered every other week (Q2W). Participants may self-administer injection after proper training.
  • Benralizumab — BIOLOGICAL
    Benralizumab, an interleukin-5 receptor treatment, will be administered through a subcutaneous injection every 4 weeks (Q4W). Participants may self-administer injection after proper training.

Study Details

In this study, a new method will be used to evaluate response to 2 approved biologic therapies, and assess how well each patient responds to each asthma treatment. This study will measure the response to these treatments using genomic and biologic measurements obtained from participants biosamples. By evaluating response to 2 different biologic therapies, this study has the potential to provide an in-depth understanding of the mechanisms underlying severe asthma that will inform and change treatment decisions, and may ultimately lead to a change in the way that asthma patients are evaluated for potential personalized therapies and maximize the probability that the subject will respond to treatment.

Key Dates

Start date
Feb 19, 2024
Status verified
Aug 2024
Primary completion
Jun 30, 2027
Completion
Jan 31, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: Dupilumab
    600 mg once subcutaneously (given as two 300 mg injections), followed by 300 mg subcutaneously every other week.
  • Active Comparator: Benralizumab
    30 mg subcutaneously every 4 weeks.

Primary Outcome Measure

Predicting asthma outcomes and therapeutic responses [ Time Frame: After 16 weeks (for each biologic) ]

Central Contacts

  • Clinical Trial Operations and Data Management Specialist UA-DCC
    520-626-9552
    [email protected]

Locations (3)

FacilityCityStateZIPSite coordinators
Mayo ClinicScottsdaleArizona85259
Karalyn Folmes, Ph.D.
[email protected]
480-301-4298
Gene R Bleecker, MD (PRINCIPAL_INVESTIGATOR)
Deborah A Meyers, PhD (PRINCIPAL_INVESTIGATOR)
University of California, San DiegoLa JollaCalifornia92093
Asthma Research Team
[email protected]
619-431-0995
Kelan Tantisira, MD (PRINCIPAL_INVESTIGATOR)
Praveen Akuthota, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06520
Katherine Spaulding
[email protected]
203-737-5572
Geoffrey L Chupp, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Mayo Clinic· Scottsdale, AZUniversity of California, San Diego· La Jolla, CAYale University· New Haven, CT

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