nctId: NCT06280716 id: 18817 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 overallStatus: NOT_YET_RECRUITING date: 2024-05-06 date: 2025-12-17 date: 2026-11-04 date: 2024-02-28 date: 2024-04-19 name: Eli Lilly and Company class: INDUSTRY 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. conditions: Atopic Dermatitis studyType: INTERVENTIONAL phases: PHASE3 allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Randomized, double-blind, parallel group, placebo controlled primaryPurpose: TREATMENT masking: DOUBLE maskingDescription: Double whoMasked: PARTICIPANT whoMasked: INVESTIGATOR count: 430 type: ESTIMATED name: Placebo name: Lebrikizumab name: Topical Corticosteroid measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono Cohort measure: Percentage of Participants Achieving EASI-75 at Week 16 for Combo Cohort 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 measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo Cohort 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 measure: Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort 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 measure: Percentage of Participants Achieving EASI-90 at Week 16 for Mono Cohort 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 measure: Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort sex: ALL minimumAge: 12 Years stdAges: CHILD stdAges: ADULT stdAges: OLDER_ADULT facility: Wannan Medical College Yijishan Hospital city: Wuhu state: Anhui zip: 241001 country: China name: Chao Ci role: PRINCIPAL_INVESTIGATOR lat: 31.33728 lon: 118.37351 facility: China-Japan Friendship Hospital city: Beijing state: Beijing zip: 100029 country: China name: Yong Cui role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University People's Hospital city: Beijing state: Beijing zip: 100034 country: China name: Jianzhong Zhang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Children's hospital, Capital Medical University city: Beijing state: Beijing zip: 100045 country: China name: Zigang Xu role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Friendship Hospital city: Beijing state: Beijing zip: 100050 country: China name: Linfeng Li role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Peking University Third Hospital city: Beijing state: Beijing zip: 100091 country: China name: Wenhui Wang role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tongren Hospital affiliated to Capital Medical University city: Beijing state: Beijing zip: 100730 country: China name: Aihua Wei role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: Beijing Tsinghua Changgung Hospital city: Beijing state: Beijing zip: 102202 country: China name: Yi Zhao role: PRINCIPAL_INVESTIGATOR lat: 39.9075 lon: 116.39723 facility: The Children's Hospital of Chongqing Medical University city: Chongqing state: Chongqing zip: 400065 country: China name: Hua Wang role: PRINCIPAL_INVESTIGATOR lat: 29.56278 lon: 106.55278 facility: Zhongshan Hospital Fudan University (Xiamen Branch) city: Xiamen state: Fujian zip: 361015 country: China name: Yi Wei role: PRINCIPAL_INVESTIGATOR lat: 24.47979 lon: 118.08187 facility: Guangdong Province Dermatology Hospital city: Guangzhou state: Guangdong zip: 510018 country: China name: Yunsheng Liang role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: The First Affiliated Hospital, Sun Yat-sen University city: Guangzhou state: Guangdong zip: 510180 country: China name: Jiande han role: PRINCIPAL_INVESTIGATOR lat: 23.11667 lon: 113.25 facility: Shenzhen Children's Hospital city: Shenzhen state: Guangdong zip: 518026 country: China name: Ping Li role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Peking University Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518036 country: China name: Xia Dou role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: The University of Hong Kong-Shenzhen Hospital city: Shenzhen state: Guangdong zip: 518053 country: China name: zhenying zhang role: PRINCIPAL_INVESTIGATOR lat: 22.54554 lon: 114.0683 facility: Hainan General Hospital city: Haikou state: Hainan zip: 570311 country: China name: Ke Han role: PRINCIPAL_INVESTIGATOR lat: 20.04583 lon: 110.34167 facility: The First Hospital of Wuhan city: Wuhan state: Hubei zip: 430022 country: China name: Liuqing Chen role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Wuhan Union Hospital city: Wuhan state: Hubei zip: 430022 country: China name: Nengxing Lin role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Renmin Hospital of Wuhan University city: Wuhan state: Hubei zip: 430060 country: China name: Tiechi Lei role: PRINCIPAL_INVESTIGATOR lat: 30.58333 lon: 114.26667 facility: Hunan Children's Hospital city: Changsha state: Hunan zip: 410007 country: China name: Zhu Wei role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Xiangya Hospital Central South University city: Changsha state: Hunan zip: 410008 country: China name: Su Juan role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: The Second Xiangya Hospital of Central South University city: Changsha state: Hunan zip: 410011 country: China name: Hai Long role: PRINCIPAL_INVESTIGATOR lat: 28.19874 lon: 112.97087 facility: Wuxi No.2 People's Hospital city: Wuxi state: Jiangsu zip: 214000 country: China name: Xunyi Dai role: PRINCIPAL_INVESTIGATOR lat: 31.56887 lon: 120.28857 facility: Affiliated Hospital of Jiangsu University city: Zhenjiang state: Jiangsu zip: 212000 country: China name: Yumei Li role: PRINCIPAL_INVESTIGATOR lat: 32.21086 lon: 119.45508 facility: The Second Hospital of Jilin University city: Changchun state: Jilin zip: 130000 country: China name: Fuqiu Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The First Hospital of Jilin University city: Changchun state: Jilin zip: 130021 country: China name: Shanshan Li role: PRINCIPAL_INVESTIGATOR lat: 43.88 lon: 125.32278 facility: The Second Affiliated Hospital of Xi'an Jiaotong University city: Xi'An state: Shaanxi zip: 710004 country: China name: Songmei Geng role: PRINCIPAL_INVESTIGATOR lat: 34.25833 lon: 108.92861 facility: Huashan Hospital Affiliated Fudan University city: Shanghai state: Shanghai zip: 200040 country: China name: Chaoying Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Shanghai Tenth People's Hospital city: Shanghai state: Shanghai zip: 200072 country: China name: Jun Gu role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: Children's Hospital of Shanxi city: Taiyuan state: Shanxi zip: 030013 country: China name: Xinglian Zhang role: PRINCIPAL_INVESTIGATOR lat: 37.86944 lon: 112.56028 facility: West China Hospital, Sichuan University city: Cheng Du state: Sichuan zip: 610041 country: China name: Xian Jiang role: PRINCIPAL_INVESTIGATOR facility: Kunming Children's hospital city: Kunming state: Yunnan zip: 650034 country: China name: Hong Shu role: PRINCIPAL_INVESTIGATOR lat: 25.03889 lon: 102.71833 facility: The First Affiliated Hospital, Zhejiang University city: Hangzhou state: Zhejiang zip: 310003 country: China name: Jianjun Qiao role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Hangzhou Third People's Hospital city: Hangzhou state: Zhejiang zip: 310009 country: China name: Aie Xu role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital city: Hangzhou state: Zhejiang zip: 310016 country: China name: Hao Cheng role: PRINCIPAL_INVESTIGATOR lat: 30.29365 lon: 120.16142 facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital city: Yiwu state: Zhejiang zip: 322000 country: China name: Lunfei Liu role: PRINCIPAL_INVESTIGATOR lat: 29.31506 lon: 120.07676 facility: The First Affiliated Hospital Of Fujian Medical University city: Fuzhou zip: 350005 country: China name: Chao JI role: PRINCIPAL_INVESTIGATOR lat: 26.06139 lon: 119.30611 facility: Shanghai Skin Disease Hospital city: Shanghai zip: 200071 country: China name: Yuling Shi role: PRINCIPAL_INVESTIGATOR lat: 31.22222 lon: 121.45806 facility: The First Hospital of Hebei Medical University city: Shijiazhuang zip: 050031 country: China name: Guoqiang Zhang role: PRINCIPAL_INVESTIGATOR lat: 38.04139 lon: 114.47861 facility: The Catholic University of Korea, Incheon St. Mary's Hospital city: Bupyeong-gu state: Incheon-gwangyeoksi [Incheon] zip: 21431 country: Korea, Republic of name: Sang-Hyun Cho role: PRINCIPAL_INVESTIGATOR facility: Korea University Ansan Hospital city: Ansan-si state: Kyǒnggi-do zip: 15355 country: Korea, Republic of name: Sang Wook Son role: PRINCIPAL_INVESTIGATOR lat: 37.32361 lon: 126.82194 facility: National Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 01812 country: Korea, Republic of name: JiYoung Ahn role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 facility: Asan Medical Center city: Seoul state: Seoul-teukbyeolsi [Seoul] zip: 05505 country: Korea, Republic of name: Chong Hyun Won role: PRINCIPAL_INVESTIGATOR lat: 37.566 lon: 126.9784 hasResults: False