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