protocolSection identificationModule nctId: NCT06385236, orgStudyIdInfo id: 804913, secondaryIdInfos id: R01HL161362, type: NIH, link: https://reporter.nih.gov/quickSearch/R01HL161362, briefTitle: Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping, acronym: EPIPHANY, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-19, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2028-01-31, studyFirstPostDateStruct date: 2024-04-26, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: University of California, San Diego, class: OTHER, collaborators name: Mayo Clinic, collaborators name: Yale University, collaborators name: University of Arizona, collaborators name: Harvard University, collaborators name: Brigham and Women's Hospital, collaborators name: National Heart, Lung, and Blood Institute (NHLBI), descriptionModule briefSummary: 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., conditionsModule conditions: Moderate to Severe Asthma, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: The study is significant in determining molecular disease endotypes in a large group of moderate to severe asthmatics. By evaluating within-person genomic level changes and 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., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Dupilumab, interventions name: Benralizumab, outcomesModule primaryOutcomes measure: Predicting asthma outcomes and therapeutic responses, primaryOutcomes measure: Responses to the biologic therapies at the single cell level, primaryOutcomes measure: Unique asthma subgroups clinical and molecular endotype approaches, secondaryOutcomes measure: Asthma Control Questionnaire (ACQ), secondaryOutcomes measure: CompEx events, secondaryOutcomes measure: Asthma Quality of Life Questionnaire (AQLQ), secondaryOutcomes measure: Forced expiratory volume in 1 second (FEV1), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic, status: RECRUITING, city: Scottsdale, state: Arizona, zip: 85259, country: United States, contacts name: Karalyn Folmes, Ph.D., role: CONTACT, phone: 480-301-4298, email: folmes.karalyn@mayo.edu, contacts name: Gene R Bleecker, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Deborah A Meyers, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.50921, lon: -111.89903, locations facility: University of California, San Diego, status: RECRUITING, city: La Jolla, state: California, zip: 92093, country: United States, contacts name: Asthma Research Team, role: CONTACT, phone: 619-431-0995, email: asthma@health.ucsd.edu, contacts name: Kelan Tantisira, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Praveen Akuthota, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: Yale University, status: RECRUITING, city: New Haven, state: Connecticut, zip: 06520, country: United States, contacts name: Katherine Spaulding, role: CONTACT, phone: 203-737-5572, email: katherine.spaulding@yale.edu, contacts name: Geoffrey L Chupp, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.30815, lon: -72.92816, hasResults: False