protocolSection identificationModule nctId: NCT06280716, orgStudyIdInfo id: 18817, secondaryIdInfos id: J2T-MC-KGBW, type: OTHER, domain: Eli Lilly and Company, briefTitle: A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-06, primaryCompletionDateStruct date: 2025-12-17, completionDateStruct date: 2026-11-04, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-04-19, 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 with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks., conditionsModule conditions: Atopic Dermatitis, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 430, type: ESTIMATED, armsInterventionsModule interventions name: Placebo, interventions name: Lebrikizumab, interventions name: Topical Corticosteroid, outcomesModule primaryOutcomes measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort, primaryOutcomes measure: Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants With a Itch Numerical Rating Scale (NRS) Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort, secondaryOutcomes measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage of Participants With a Itch NRS Score of ≥4-Points at Baseline who Achieve a ≥4-Point Reduction in Itch NRS Score From Baseline to Week 16 for Mono Cohort, secondaryOutcomes measure: Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort, eligibilityModule sex: ALL, minimumAge: 12 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Wannan Medical College Yijishan Hospital, city: Wuhu, state: Anhui, zip: 241001, country: China, contacts name: Chao Ci, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.33728, lon: 118.37351, locations facility: China-Japan Friendship Hospital, city: Beijing, state: Beijing, zip: 100029, country: China, contacts name: Yong Cui, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University People's Hospital, city: Beijing, state: Beijing, zip: 100034, country: China, contacts name: Jianzhong Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Children's hospital, Capital Medical University, city: Beijing, state: Beijing, zip: 100045, country: China, contacts name: Zigang Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Friendship Hospital, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Linfeng Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, city: Beijing, state: Beijing, zip: 100091, country: China, contacts name: Wenhui Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tongren Hospital affiliated to Capital Medical University, city: Beijing, state: Beijing, zip: 100730, country: China, contacts name: Aihua Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Beijing Tsinghua Changgung Hospital, city: Beijing, state: Beijing, zip: 102202, country: China, contacts name: Yi Zhao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, locations facility: The Children's Hospital of Chongqing Medical University, city: Chongqing, state: Chongqing, zip: 400065, country: China, contacts name: Hua Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.56278, lon: 106.55278, locations facility: Zhongshan Hospital Fudan University (Xiamen Branch), city: Xiamen, state: Fujian, zip: 361015, country: China, contacts name: Yi Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 24.47979, lon: 118.08187, locations facility: Guangdong Province Dermatology Hospital, city: Guangzhou, state: Guangdong, zip: 510018, country: China, contacts name: Yunsheng Liang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital, Sun Yat-sen University, city: Guangzhou, state: Guangdong, zip: 510180, country: China, contacts name: Jiande han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, locations facility: Shenzhen Children's Hospital, city: Shenzhen, state: Guangdong, zip: 518026, country: China, contacts name: Ping Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Peking University Shenzhen Hospital, city: Shenzhen, state: Guangdong, zip: 518036, country: China, contacts name: Xia Dou, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: The University of Hong Kong-Shenzhen Hospital, city: Shenzhen, state: Guangdong, zip: 518053, country: China, contacts name: zhenying zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.54554, lon: 114.0683, locations facility: Hainan General Hospital, city: Haikou, state: Hainan, zip: 570311, country: China, contacts name: Ke Han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.04583, lon: 110.34167, locations facility: The First Hospital of Wuhan, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Liuqing Chen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Wuhan Union Hospital, city: Wuhan, state: Hubei, zip: 430022, country: China, contacts name: Nengxing Lin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Renmin Hospital of Wuhan University, city: Wuhan, state: Hubei, zip: 430060, country: China, contacts name: Tiechi Lei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.58333, lon: 114.26667, locations facility: Hunan Children's Hospital, city: Changsha, state: Hunan, zip: 410007, country: China, contacts name: Zhu Wei, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Xiangya Hospital Central South University, city: Changsha, state: Hunan, zip: 410008, country: China, contacts name: Su Juan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: The Second Xiangya Hospital of Central South University, city: Changsha, state: Hunan, zip: 410011, country: China, contacts name: Hai Long, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.19874, lon: 112.97087, locations facility: Wuxi No.2 People's Hospital, city: Wuxi, state: Jiangsu, zip: 214000, country: China, contacts name: Xunyi Dai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.56887, lon: 120.28857, locations facility: Affiliated Hospital of Jiangsu University, city: Zhenjiang, state: Jiangsu, zip: 212000, country: China, contacts name: Yumei Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.21086, lon: 119.45508, locations facility: The Second Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130000, country: China, contacts name: Fuqiu Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: The First Hospital of Jilin University, city: Changchun, state: Jilin, zip: 130021, country: China, contacts name: Shanshan Li, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88, lon: 125.32278, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xi'An, state: Shaanxi, zip: 710004, country: China, contacts name: Songmei Geng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Huashan Hospital Affiliated Fudan University, city: Shanghai, state: Shanghai, zip: 200040, country: China, contacts name: Chaoying Gu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shanghai Tenth People's Hospital, city: Shanghai, state: Shanghai, zip: 200072, country: China, contacts name: Jun Gu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Children's Hospital of Shanxi, city: Taiyuan, state: Shanxi, zip: 030013, country: China, contacts name: Xinglian Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.86944, lon: 112.56028, locations facility: West China Hospital, Sichuan University, city: Cheng Du, state: Sichuan, zip: 610041, country: China, contacts name: Xian Jiang, role: PRINCIPAL_INVESTIGATOR, locations facility: Kunming Children's hospital, city: Kunming, state: Yunnan, zip: 650034, country: China, contacts name: Hong Shu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.03889, lon: 102.71833, locations facility: The First Affiliated Hospital, Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, contacts name: Jianjun Qiao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Hangzhou Third People's Hospital, city: Hangzhou, state: Zhejiang, zip: 310009, country: China, contacts name: Aie Xu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Sir Run Run Shaw Hospital, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Hao Cheng, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital, city: Yiwu, state: Zhejiang, zip: 322000, country: China, contacts name: Lunfei Liu, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.31506, lon: 120.07676, locations facility: The First Affiliated Hospital Of Fujian Medical University, city: Fuzhou, zip: 350005, country: China, contacts name: Chao JI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.06139, lon: 119.30611, locations facility: Shanghai Skin Disease Hospital, city: Shanghai, zip: 200071, country: China, contacts name: Yuling Shi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The First Hospital of Hebei Medical University, city: Shijiazhuang, zip: 050031, country: China, contacts name: Guoqiang Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.04139, lon: 114.47861, locations facility: The Catholic University of Korea, Incheon St. Mary's Hospital, city: Bupyeong-gu, state: Incheon-gwangyeoksi [Incheon], zip: 21431, country: Korea, Republic of, contacts name: Sang-Hyun Cho, role: PRINCIPAL_INVESTIGATOR, locations facility: Korea University Ansan Hospital, city: Ansan-si, state: Kyǒnggi-do, zip: 15355, country: Korea, Republic of, contacts name: Sang Wook Son, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.32361, lon: 126.82194, locations facility: National Medical Center, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 01812, country: Korea, Republic of, contacts name: JiYoung Ahn, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: Asan Medical Center, city: Seoul, state: Seoul-teukbyeolsi [Seoul], zip: 05505, country: Korea, Republic of, contacts name: Chong Hyun Won, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False