protocolSection identificationModule nctId: NCT06339008, orgStudyIdInfo id: 18789, secondaryIdInfos id: J2T-MC-KGBT, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2023-508817-18-00, type: OTHER, domain: EU Clinical Trial Number, briefTitle: A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-12, primaryCompletionDateStruct date: 2025-05-30, completionDateStruct date: 2026-05-01, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months, conditionsModule conditions: Perennial Allergic Rhinitis (PAR), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 450, type: ESTIMATED, armsInterventionsModule interventions name: LY3650150, interventions name: Placebo, interventions name: Standard therapy for INCS, outcomesModule primaryOutcomes measure: Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16, secondaryOutcomes measure: Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16, secondaryOutcomes measure: Mean CFBL in RQLQ(S) at week 56, secondaryOutcomes measure: Mean CFBL in TNSS at Week 4, secondaryOutcomes measure: Mean CFBL in TNSS at Week 56, secondaryOutcomes measure: Mean CFBL in Postnasal drip score at Week 16, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Southern California Research, city: California City, state: California, zip: 92691, country: United States, contacts role: CONTACT, phone: 949-276-4917, contacts name: Warner Carr, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.1258, lon: -117.9859, locations facility: 310 Clinical Research, city: Inglewood, state: California, zip: 90301, country: United States, contacts role: CONTACT, phone: 310-878-2636, contacts name: Soheil Hekmat, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.96168, lon: -118.35313, locations facility: Allergy and Asthma, city: San Diego, state: California, zip: 92123, country: United States, contacts role: CONTACT, phone: 858-268-2368, phoneExt: 143, contacts name: Bob Geng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.71533, lon: -117.15726, locations facility: Asthma and Allergy Associates, PC, city: Colorado Springs, state: Colorado, zip: 80907-6231, country: United States, contacts role: CONTACT, phone: 719-473-8330 x5, contacts name: Luke Webb, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.83388, lon: -104.82136, locations facility: Florida Center For Allergy & Asthma Care Aventura, city: Aventura, state: Florida, zip: 33180, country: United States, contacts role: CONTACT, phone: 305-931-7583, contacts name: Jaime Landman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.95648, lon: -80.13921, locations facility: Bluegrass Allergy Research, city: Lexington, state: Kentucky, zip: 40509, country: United States, contacts role: CONTACT, phone: 859-303-7191, contacts name: William Greisner, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: Allergy, Asthma & Sinus Center, city: Greenfield, state: Massachusetts, zip: 53228, country: United States, contacts role: CONTACT, phone: 414-529-8519, contacts name: Gary Steven, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.58759, lon: -72.59953, locations facility: Respiratory Medicine Research Institute of Michigan, PLC, city: Ypsilanti, state: Michigan, zip: 48197, country: United States, contacts role: CONTACT, phone: 734-528-0477, contacts name: Jeffrey Leflein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.24115, lon: -83.61299, locations facility: Clinical Research Institute, city: Minneapolis, state: Minnesota, zip: 55402, country: United States, contacts role: CONTACT, phone: 612-333-2200, phoneExt: 378, contacts name: Gary Berman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.97997, lon: -93.26384, locations facility: Allergy and Asthma Consultants, city: Saint Louis, state: Missouri, zip: 63141, country: United States, contacts role: CONTACT, phone: 314-991-5117, contacts name: Robert Onder, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, locations facility: Dr. Patrick Perin, city: Teaneck, state: New Jersey, zip: 07666, country: United States, contacts name: Patrick Perin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.8976, lon: -74.01597, locations facility: Bernstein Clinical Research Center, LLC, city: Cincinnati, state: Ohio, zip: 45236, country: United States, contacts role: CONTACT, phone: 314-991-5117, contacts name: David Bernstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.12713, lon: -84.51435, locations facility: Northwest Research Center, city: Portland, state: Oregon, zip: 97202, country: United States, contacts role: CONTACT, phone: 503-238-6233, contacts name: Anthony Montanaro, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.52345, lon: -122.67621, locations facility: Allergy and Clinical Immunology Associates, city: Pittsburgh, state: Pennsylvania, zip: 15241, country: United States, contacts role: CONTACT, phone: 412-833-4051, phoneExt: 116, contacts name: Michael Palumbo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Kerrville Allergy and Asthma Associates, city: Kerrville, state: Texas, zip: 78028, country: United States, contacts role: CONTACT, phone: 830-896-1433, contacts name: Dale Mohar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.04743, lon: -99.14032, locations facility: Allergy Asthma Research Institute, city: Waco, state: Texas, zip: 76712, country: United States, contacts role: CONTACT, phone: 254-741-8151, contacts name: Niran Amar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.54933, lon: -97.14667, hasResults: False