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Evaluating Dupilumab and Benralizumab for Moderate to Severe Asthma

This study is looking at how two approved medications, Dupilumab and Benralizumab, work in people with moderate to severe asthma. Dupilumab is given as an injection, with an initial dose of 600 mg followed by 300 mg every other week. Benralizumab is also an injection, given every 4 weeks. The study aims to understand how well each patient responds to these treatments by looking at genetic and biological information from your samples. This research could help doctors better predict which treatment will work best for individual patients. You may be able to join if you are 18 to 75 years old, use medium or high-dose inhaled corticosteroids and another asthma controller medication, and have uncontrolled asthma. The study's success will be measured by how well it predicts asthma outcomes and treatment responses after 16 weeks for each medication. The current recruitment status is unclear.

Study design
This interventional study plans to enroll 120 participants with moderate to severe asthma. It will evaluate responses to two different biological therapies in a random order.
What's involved
You will receive injections of either Dupilumab or Benralizumab, and may self-administer injections after training. The study will involve pre- and post-therapy characterizations and collection of biological samples.
Compensation
Not stated in the trial record.
Follow-up
Responses to the therapies will be measured after 16 weeks for each biologic treatment.

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NCT06385236

Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping

Recruiting
PHASE4Ages 18–75InterventionalTreatment
University of California, San Diego
~120 participants
Updated 2024-08-19 on ClinicalTrials.gov
What's tested:DupilumabBenralizumab

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Predicting asthma outcomes and therapeutic responses
Measured over After 16 weeks (for each biologic)
+2 more outcomes measured

Conditions

Moderate to Severe Asthma

Explore related trials

Asthma

Where it's being run

3 sites across 3 states
Arizona1
California1
Connecticut1

Study leadership

  • Kelan Tantisira, MD · PRINCIPAL_INVESTIGATOR · University of California, San Diego

Who to contact

Clinical Trial Operations and Data Management Specialist UA-DCC
[email protected]
520-626-9552
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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:
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

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:
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.

What this trial measures

  • Predicting asthma outcomes and therapeutic responsesAfter 16 weeks (for each biologic)

    The primary outcomes of our therapeutic assessments are the genomic signatures that will identify novel predictive biomarkers and provide mechanistic insights to the heterogeneous response to a specific therapy. Our genomic signatures will focus on global gene expression using RNA sequencing (RNA-Seq).

  • Responses to the biologic therapies at the single cell levelAfter 16 weeks (for each biologic)

    Single cell (sc) RNA-Seq on sputum and blood samples will be assayed at baseline and after each evoked (drug) phenotype.

  • Unique asthma subgroups clinical and molecular endotype approachesAfter 16 weeks (for each biologic)

    Clinical and molecular endotype will be independently assessed for their prognostic association with treatment response through scRNA-seq and RNA-sequencing data at baseline and following therapy.