protocolSection identificationModule nctId: NCT06338995, orgStudyIdInfo id: 18790, secondaryIdInfos id: J2T-MC-KGBU, type: OTHER, domain: Eli Lilly and Company, secondaryIdInfos id: 2023-508760-29-00, type: OTHER, domain: EU CT Number, briefTitle: A Study of Lebrikizumab (LY3650150) in Adult Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-11-22, completionDateStruct date: 2026-10-25, studyFirstPostDateStruct date: 2024-04-01, lastUpdatePostDateStruct date: 2024-04-01, 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 chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months., conditionsModule conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP), designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: LY3650150, interventions name: Placebo, interventions name: Standard therapy for INCS, outcomesModule primaryOutcomes measure: Mean Change From Baseline (CFBL) in Participant Reported Nasal Congestion Score (NCS) Severity, primaryOutcomes measure: Mean CFBL in Endoscopic Nasal Polyp Score (NPS), secondaryOutcomes measure: Mean change in Opacification of Sinuses Measured by the Lund Mackay score (LMK), secondaryOutcomes measure: Mean change in Forced Expiratory Volume in 1 Second (FEV1), secondaryOutcomes measure: Mean CFBL in Severity of Loss of Smell, secondaryOutcomes measure: Mean CFBL in Postnasal Drip, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: South Louisiana Ear, Nose, Throat & Facial Plastic Surgery - PPDS, city: Mandeville, state: Louisiana, zip: 70448, country: United States, contacts name: James Connolly, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.35825, lon: -90.06563, locations facility: Ear Nose and Throat Associates of Texas PA, city: McKinney, state: Texas, zip: 75070-5735, country: United States, contacts name: Dale Ehmer, Jr., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.19762, lon: -96.61527, locations facility: Alamo ENT Associates, city: San Antonio, state: Texas, zip: 78258-3227, country: United States, contacts role: CONTACT, phone: 210-545-0404, contacts name: Jeffrey Rosenbloom, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.42412, lon: -98.49363, locations facility: Richmond Ear Nose and Throat, city: Richmond, state: Virginia, zip: 23235, country: United States, contacts role: CONTACT, phone: 804-622-3768, contacts name: Michael Armstrong, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.55376, lon: -77.46026, hasResults: False