Phase
Condition
Rosacea
Skin Infections/disorders
Allergy
Treatment
Placebo
Topical Corticosteroid
Lebrikizumab
Clinical Study ID
Ages > 12 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Have chronic AD that has been present for ≥1 year before the screening period orhave chronic eczema and meet the AAD criteria.
Have moderate-to-severe AD, including all of the following at the baseline: EASIscore ≥16, IGA score ≥3 (scale of 0 to 4), ≥10% BSA of AD involvement.
Have a documented history provided by a physician and/or investigator of inadequateresponse to existing topical medications within 6 months preceding screening asdefined by at least 1 of the following:
Inability to achieve good disease control, defined as mild disease or betterafter use of at least a medium-potency TCS for at least 4 weeks, or for themaximum duration recommended by the product prescribing information, whicheveris shorter. TCS may be used with or without TCIs and/or topical Janus kinase (JAK) inhibitors.
Participants who failed systemic therapies intended to treat AD within 6 monthspreceding screening, such as cyclosporine, MTX, azathioprine, and MMF, willalso be considered as surrogates for having inadequate response to topicaltherapy.
Adolescents body weight must be ≥40 kg at baseline.
Males may participate in this trial and comply with specific local government studyrequirements. Females of childbearing potential and females not of childbearingpotential may participate in this trial.
Exclusion
Exclusion Criteria:
Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
Have a history of anaphylaxis or uncontrolled chronic disease that might requirebursts of oral corticosteroids.
Have a current or recent acute, active infection. For at least 30 days beforescreening and up to the randomization, participants must have no symptoms or signsof confirmed or suspected infection and must have completed any appropriateanti-infective treatment.
Have had Serious, Opportunistic, Chronic and Recurring infection within 3 monthsprior to the screening or develops any of these infections before the randomization.
Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has notbeen treated with a complete course of appropriate therapy or such treatment isunderway.
Have a current infection with HBV, HCV, human immunodeficiency virus (HIV)infection.
Have presence of skin comorbidities that may interfere with study assessments.
Have a diagnosis or history of malignant disease within 5 years before screening,with the following exceptions:
basal cell or squamous epithelial carcinomas of the skin that have beenresected with no evidence of metastatic disease for 3 years, and
cervical carcinoma in situ, with no evidence of recurrence within 5 yearsbefore screening visit.
- Pregnant or breastfeeding women or women planning to become pregnant or breastfeedduring the study.
Study Design
Connect with a study center
Wannan Medical College Yijishan Hospital
Wuhu, Anhui 241001
ChinaActive - Recruiting
Beijing Children's hospital, Capital Medical University
Beijing, Beijing 100045
ChinaActive - Recruiting
Beijing Friendship Hospital
Beijing, Beijing 100050
ChinaActive - Recruiting
Beijing Friendship Hospital Affiliate of Capital University
Beijing, Beijing 100050
ChinaActive - Recruiting
Beijing Tongren Hospital affiliated to Capital Medical University
Beijing, Beijing 100730
ChinaActive - Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing 102202
ChinaActive - Recruiting
Children's Hospital Capital Institute of Pediatrics
Beijing, Beijing 100020
ChinaSite Not Available
China-Japan Friendship Hospital
Beijing, Beijing 100029
ChinaActive - Recruiting
Peking University People's Hospital
Beijing, Beijing 100034
ChinaActive - Recruiting
Peking University Third Hospital
Beijing, Beijing 100091
ChinaActive - Recruiting
The Children's Hospital of Chongqing Medical University
Chongqing, Chongqing 400065
ChinaActive - Recruiting
Zhongshan Hospital Fudan University (Xiamen Branch)
Xiamen, Fujian 361015
ChinaActive - Recruiting
Guangdong Province Dermatology Hospital
Guangzhou, Guangdong 510018
ChinaActive - Recruiting
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong 510180
ChinaActive - Recruiting
Huazhong University of Science and Technology - Shenzhen Sixth
Shenzhen, Guangdong 518052
ChinaSite Not Available
Peking University Shenzhen Hospital
Shenzhen, Guangdong 518036
ChinaActive - Recruiting
Shenzhen Children's Hospital
Shenzhen, Guangdong 518026
ChinaActive - Recruiting
The University of Hong Kong-Shenzhen Hospital
Shenzhen, Guangdong 518053
ChinaActive - Recruiting
Hainan General Hospital
Haikou, Hainan 570311
ChinaActive - Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei 430060
ChinaActive - Recruiting
The First Hospital of Wuhan
Wuhan, Hubei 430022
ChinaActive - Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei 430022
ChinaActive - Recruiting
Wuhan Union Hospital
Wuhan, Hubei 430022
ChinaActive - Recruiting
Hunan Children's Hospital
Changsha, Hunan 410007
ChinaActive - Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
ChinaActive - Recruiting
Xiangya Hospital Central South University
Changsha, Hunan 410008
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
Wuxi No.2 People's Hospital
Wuxi, Jiangsu 214000
ChinaActive - Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu 212000
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun, Jilin 130021
ChinaActive - Recruiting
The Second Hospital of Jilin University
Changchun, Jilin 130000
ChinaActive - Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'An, Shaanxi 710004
ChinaActive - Recruiting
Huashan Hospital Affiliated Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaActive - Recruiting
Shanghai Children's Hospital
Shanghai, Shanghai 200062
ChinaSite Not Available
Shanghai Sixth People's Hospital
Shanghai, Shanghai 200030
ChinaActive - Recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai 200072
ChinaActive - Recruiting
Children's Hospital of Shanxi
Taiyuan, Shanxi 030013
ChinaActive - Recruiting
West China Hospital, Sichuan University
Cheng Du, Sichuan 610041
ChinaActive - Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
Kunming Children's hospital
Kunming, Yunnan 650034
ChinaSite Not Available
Hangzhou Third People's Hospital
Hangzhou, Zhejiang 310009
ChinaSite Not Available
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang 310016
ChinaActive - Recruiting
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang 310016
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
The First People's Hospital of Hangzhou
Hangzhou, Zhejiang 310000
ChinaActive - Recruiting
The first Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
Zhejiang University School of Medicine - The Fourth Affiliated Hospital
Yiwu, Zhejiang 322000
ChinaActive - Recruiting
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005
ChinaActive - Recruiting
Shanghai Skin Disease Hospital
Shanghai, 200071
ChinaActive - Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
ChinaActive - Recruiting
The Catholic University of Korea, Incheon St. Mary's Hospital
Bupyeong-gu, Incheon-gwangyeoksi [Incheon] 21431
Korea, Republic ofActive - Recruiting
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do 15355
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 05505
Korea, Republic ofActive - Recruiting
Hallym University Kangnam Sacred Heart Hospital
Seoul, Seoul-teukbyeolsi [Seoul] 07441
Korea, Republic ofActive - Recruiting
National Medical Center
Seoul, Seoul-teukbyeolsi [Seoul] 01812
Korea, Republic ofActive - Recruiting
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