NCT06385236 Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
| NCT ID | NCT06385236 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | University of California, San Diego |
| Condition | Moderate to Severe Asthma |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-19 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-02-19 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Clinical Trial Operations and Data Management Specialist UA-DCC
✉ bio5-epiphanydcc@arizona.edu📞 520-626-9552
Kelan Tantisira, MD
PRINCIPAL INVESTIGATOR
University of California, San Diego
Frequently Asked Questions
Who can join the NCT06385236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Moderate to Severe Asthma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06385236 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06385236 currently recruiting?
Yes, NCT06385236 is actively recruiting participants. Contact the research team at bio5-epiphanydcc@arizona.edu for enrollment information.
Where is the NCT06385236 trial being conducted?
This trial is being conducted at Scottsdale, United States, La Jolla, United States, New Haven, United States.
Who is sponsoring the NCT06385236 clinical trial?
NCT06385236 is sponsored by University of California, San Diego. The principal investigator is Kelan Tantisira, MD at University of California, San Diego. The trial plans to enroll 120 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.