A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis

Last updated: March 28, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Rosacea

Skin Infections/disorders

Allergy

Treatment

Placebo

Topical Corticosteroid

Lebrikizumab

Clinical Study ID

NCT06280716
18817
J2T-MC-KGBW
  • Ages > 12
  • All Genders

Study Summary

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.

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:

  1. 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.

  2. 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:

  1. basal cell or squamous epithelial carcinomas of the skin that have beenresected with no evidence of metastatic disease for 3 years, and

  2. 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

Total Participants: 430
Treatment Group(s): 3
Primary Treatment: Placebo
Phase: 3
Study Start date:
April 24, 2024
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui 241001
    China

    Active - Recruiting

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing 100045
    China

    Active - Recruiting

  • Beijing Friendship Hospital

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing, Beijing 100050
    China

    Active - Recruiting

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing 102202
    China

    Active - Recruiting

  • Children's Hospital Capital Institute of Pediatrics

    Beijing, Beijing 100020
    China

    Site Not Available

  • China-Japan Friendship Hospital

    Beijing, Beijing 100029
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100091
    China

    Active - Recruiting

  • The Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing 400065
    China

    Active - Recruiting

  • Zhongshan Hospital Fudan University (Xiamen Branch)

    Xiamen, Fujian 361015
    China

    Active - Recruiting

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong 510018
    China

    Active - Recruiting

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong 510180
    China

    Active - Recruiting

  • Huazhong University of Science and Technology - Shenzhen Sixth

    Shenzhen, Guangdong 518052
    China

    Site Not Available

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong 518036
    China

    Active - Recruiting

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong 518026
    China

    Active - Recruiting

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong 518053
    China

    Active - Recruiting

  • Hainan General Hospital

    Haikou, Hainan 570311
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei 430060
    China

    Active - Recruiting

  • The First Hospital of Wuhan

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Wuhan Union Hospital

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Hunan Children's Hospital

    Changsha, Hunan 410007
    China

    Active - Recruiting

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan 410011
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Changsha, Hunan 410008
    China

    Active - Recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu 214000
    China

    Active - Recruiting

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu 212000
    China

    Active - Recruiting

  • The First Hospital of Jilin University

    Changchun, Jilin 130021
    China

    Active - Recruiting

  • The Second Hospital of Jilin University

    Changchun, Jilin 130000
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'An, Shaanxi 710004
    China

    Active - Recruiting

  • Huashan Hospital Affiliated Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

  • Shanghai Children's Hospital

    Shanghai, Shanghai 200062
    China

    Site Not Available

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai 200072
    China

    Active - Recruiting

  • Children's Hospital of Shanxi

    Taiyuan, Shanxi 030013
    China

    Active - Recruiting

  • West China Hospital, Sichuan University

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin 300052
    China

    Active - Recruiting

  • Kunming Children's hospital

    Kunming, Yunnan 650034
    China

    Site Not Available

  • Hangzhou Third People's Hospital

    Hangzhou, Zhejiang 310009
    China

    Site Not Available

  • Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310016
    China

    Active - Recruiting

  • The First Affiliated Hospital, Zhejiang University

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang 310000
    China

    Active - Recruiting

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310003
    China

    Active - Recruiting

  • Zhejiang University School of Medicine - The Fourth Affiliated Hospital

    Yiwu, Zhejiang 322000
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005
    China

    Active - Recruiting

  • Shanghai Skin Disease Hospital

    Shanghai, 200071
    China

    Active - Recruiting

  • The First Hospital of Hebei Medical University

    Shijiazhuang, 050031
    China

    Active - Recruiting

  • The Catholic University of Korea, Incheon St. Mary's Hospital

    Bupyeong-gu, Incheon-gwangyeoksi [Incheon] 21431
    Korea, Republic of

    Active - Recruiting

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do 15355
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 05505
    Korea, Republic of

    Active - Recruiting

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 07441
    Korea, Republic of

    Active - Recruiting

  • National Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 01812
    Korea, Republic of

    Active - Recruiting

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