Recruiting

Pharmacogenomics

Sponsor:

UCLA

Code:

NCT06385236

Conditions

Moderate to Severe Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Dupilumab

Benralizumab

Study Details

Brief summary:

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.

Conditions

Moderate to Severe Asthma

Study ID

NCT06385236

Start date

Feb 19, 2024

Status verified date

Aug, 2024

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Stated willingness to comply with all study procedures and availability for the duration of the study.
  • Stable asthma medications: No change in asthma medications for the past 2 months:

1. Use of medium or high dose inhaled corticosteroids (ICS) AND
2. Use of an additional asthma controller medication.
  • Baseline poor or uncontrolled asthma.
  • Evidence of asthma demonstrated by either bronchodilator reversibility (either at screening or by historical evidence) or methacholine responsiveness (by historical evidence).
  • Agreement to adhere to Lifestyle Considerations throughout study duration.

Exclusion Criteria:

  • Current participation in an interventional trial (e.g. drugs, diets, etc.).
  • Currently on an asthma biologic or having been on biologic within 3 months of screening.
  • Enrollment in a clinical trial where the study medication was administered within the past 60 days or within 5 half-lives (whichever is greater).
  • Physician diagnosis of other chronic pulmonary disorders associated with asthma-like symptoms, including, but not limited to, cystic fibrosis (CF), chronic obstructive pulmonary disease (COPD), chronic bronchitis, emphysema, severe scoliosis or chest wall deformities that affect lung function, or congenital disorders of the lungs or airways.
  • Receiving one or more immune-modulating therapies for diseases other than asthma. This includes biologics that are also approved for asthma.
  • Receiving methotrexate, mycophenolate (CellCept®), or azathioprine (Imuran®).
  • Receiving aero allergen immunotherapy and not on at least 3 months of maintenance allergen immunotherapy.
  • Underwent a bronchial thermoplasty within the last two years.
  • Born before 30 weeks of gestation.
  • Uncontrolled hypertension, defined as systolic blood pressure > 160 mm/Hg or diastolic blood pressure > 100 mm/Hg.
  • History of malignancy except non-melanoma skin cancer within the last five years.
  • History of smoking:

1. If <45 years old: Smoked for ≥5 pack-years\*
2. If ≥45 years old: Smoked ≥ 10 pack years.
  • Active use of any inhalant >1 time per month in the past year.
  • Substance abuse within the last year.
  • Unwillingness to practice medically acceptable birth control or complete abstinence during the study, current pregnancy, or lactation.
  • Requirement for daily systemic corticosteroids at the time of screening.
  • Respiratory infection within 1 month of screening.
  • Intubation for asthma in the last 12 months.
  • Any clinically significant abnormal findings in the history, physical examination, vital signs, electrocardiogram, hematology or clinical chemistry during run-in period, which in the opinion of the site investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
  • BMI > 38.
  • Allergic to any of the drugs, biologics or chemicals used in this study.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Dupilumab

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

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.

Primary outcome measure

  • Predicting asthma outcomes and therapeutic responses [ Time Frame: After 16 weeks (for each biologic) ]
  • Responses to the biologic therapies at the single cell level [ Time Frame: After 16 weeks (for each biologic) ]
  • Unique asthma subgroups clinical and molecular endotype approaches [ Time Frame: After 16 weeks (for each biologic) ]

Central Contacts and Locations

Central contacts

Clinical Trial Operations and Data Management Specialist UA-DCC

520-626-9552bio5-epiphanydcc@arizona.edu

Locations

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Karalyn Folmes, Ph.D.

480-301-4298folmes.karalyn@mayo.edu

Principal Investigator:

Gene R Bleecker, MD

University of California, San Diego

Recruiting

La Jolla, California, United States, 92093

Contacts

Asthma Research Team

619-431-0995asthma@health.ucsd.edu

Principal Investigator:

Kelan Tantisira, MD

Yale University

Recruiting

New Haven, Connecticut, United States, 06520

Contacts

Katherine Spaulding

203-737-5572katherine.spaulding@yale.edu

Principal Investigator:

Geoffrey L Chupp, MD

More Information

Sponsor

University of California, San Diego

Last update posted

Aug 19, 2024

Last verified

Aug, 2024

Keywords

  • Asthma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2024-08-19.