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NCT06385236 · ClinicalTrials.gov registry record · Phase 4
Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
A Phase 4 study of Moderate to Severe Asthma, sponsored by University of California, San Diego.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 3
- Study locations
NCT06385236: Recruiting Phase 4 study of Moderate to Severe Asthma, sponsored by University of California, San Diego.
NCT06385236 is a Phase 4 study of Moderate to Severe Asthma that is actively recruiting participants, run by University of California, San Diego. The registered enrollment target is 120 participants, below the 755-participant average among 3 other Moderate to Severe Asthma trials with a reported enrollment target (84% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06385236, a Phase 4 study of Moderate to Severe Asthma, is actively recruiting participants, sponsored by University of California, San Diego.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 3
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL Dupilumab
- BIOLOGICAL Benralizumab
Study Locations (3)
Arizona
- Mayo Clinic - Scottsdale
California
- University of California, San Diego - La Jolla
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-02-19 |
| Est. Completion | 2028-01-31 |
| Phase | Phase 4 |
What NCT06385236 shows while recruiting
NCT06385236 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 755-participant average among 3 other Moderate to Severe Asthma trials with a reported enrollment target (84% lower).
The record links to 1 condition, with Moderate to Severe Asthma appearing as the primary indexed condition, and to 2 interventions - of which Dupilumab is the first listed.
NCT06385236 reports a single indexed study location in Arizona, California, Connecticut.
Frequently Asked Questions
What is clinical trial NCT06385236 about?
NCT06385236 is a clinical study titled "Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping". 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. ...
What is the current status of trial NCT06385236?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2024-02-19. Estimated completion is 2028-01-31.
What conditions does trial NCT06385236 study?
This clinical trial studies the following conditions: Moderate to Severe Asthma.
What interventions are being tested in trial NCT06385236?
The interventions under investigation include: Dupilumab (BIOLOGICAL), Benralizumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT06385236?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06385236 being conducted?
This trial has 3 study locations across Arizona, California, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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