NCT06385236 · University of California, San Diego
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
(EPIPHANY)
What this study is about
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.
View original scientific description
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.
Interventions
BIOLOGICAL
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.
BIOLOGICAL
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 measures
Predicting asthma outcomes and therapeutic responses
Time frame: After 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 level
Time frame: After 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 approaches
Time frame: After 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 ch
Where
- Scottsdale, Arizona
- La Jolla, California
- New Haven, Connecticut
Collaborators
Mayo Clinic, Yale University, University of Arizona, Harvard University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2024 · Source of record for eligibility and locations