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

A Multicenter, Randomized, Double-Blind, Placebo-controlled, Phase 3 Trial to Investigate the Efficacy and Safety of Lebrikizumab When Used With/Without Topical Corticosteroid Treatment in Participants With Moderate-To-Severe Atopic Dermatitis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis
• Intervention / Treatment: Drug: Placebo; Drug: Lebrikizumab; Drug: Topical Corticosteroid

• Study Type: Interventional
• Enrollment (Actual): 301
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Fuzhou, China, 350005
    • The First Affiliated Hospital of Fujian Medical University
  • Shanghai, China, 200071
    • Shanghai Skin Disease Hospital
  • Anhui
    • Wuhu, Anhui, China, 241001
      • Wannan Medical College Yijishan Hospital
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100029
      • China-Japan Friendship Hospital
    • Beijing, Beijing Municipality, China, 100045
      • Beijing Children's Hospital, Capital Medical University
    • Beijing, Beijing Municipality, China, 100034
      • Peking University People's Hospital
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Friendship Hospital Affiliate of Capital University
    • Beijing, Beijing Municipality, China, 100091
      • Peking University Third Hospital
    • Beijing, Beijing Municipality, China, 100730
      • Beijing Tongren Hospital Affiliated to Capital Medical University
    • Beijing, Beijing Municipality, China, 102202
      • Beijing Tsinghua Changgung Hospital
  • Chongqing Municipality
    • Chongqing, Chongqing Municipality, China, 400065
      • The Children's Hospital of Chongqing Medical University
  • Fujian
    • Xiamen, Fujian, China, 361015
      • Zhongshan Hospital Fudan University (Xiamen Branch)
  • Guangdong
    • Guangzhou, Guangdong, China, 510018
      • Guangdong Province Dermatology Hospital
    • Guangzhou, Guangdong, China, 510180
      • The First Affiliated Hospital, Sun Yat-sen University
    • Shenzhen, Guangdong, China, 518036
      • Peking University Shenzhen Hospital
    • Shenzhen, Guangdong, China, 518026
      • Shenzhen Children's Hospital
    • Shenzhen, Guangdong, China, 518053
      • The University of Hong Kong-Shenzhen Hospital
  • Hainan
    • Haikou, Hainan, China, 570311
      • Hainan General Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 050031
      • The First Hospital of Hebei Medical University
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Union Hospital Tongji Medical College Huazhong University of Science and Technology
    • Wuhan, Hubei, China, 430060
      • Renmin Hospital of Wuhan University
    • Wuhan, Hubei, China, 430022
      • The First Hospital of Wuhan
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University
    • Changsha, Hunan, China, 410007
      • Hunan Children's Hospital
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Wuxi, Jiangsu, China, 214000
      • Wuxi No.2 People's Hospital
    • Zhenjiang, Jiangsu, China, 212000
      • Affiliated Hospital of Jiangsu University
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130000
      • The Second Hospital of Jilin University
  • Shaanxi
    • Xi'an, Shaanxi, China, 710004
      • The Second Affiliated Hospital of Xi'an Jiaotong University
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200040
      • Huashan Hospital, Fudan University
    • Shanghai, Shanghai Municipality, China, 200030
      • Shanghai sixth people's hospital
    • Shanghai, Shanghai Municipality, China, 200072
      • Shanghai Tenth People's Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030013
      • Children's Hospital of Shanxi
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital, Sichuan University
  • Tianjin Municipality
    • Tianjin, Tianjin Municipality, China, 300052
      • Tianjin Medical University General Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310003
      • the First Affiliated Hospital, Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
    • Hangzhou, Zhejiang, China, 310000
      • The First People's Hospital of Hangzhou
    • Yiwu, Zhejiang, China, 322000
      • Zhejiang University School of Medicine - The Fourth Affiliated Hospital
• South Korea
  • Incheon-gwangyeoksi [Incheon]
    • Bupyeong-gu, Incheon-gwangyeoksi [Incheon], South Korea, 21431
      • The Catholic University of Korea, Incheon St. Mary's Hospital
  • Kyǒnggi-do
    • Ansan-si, Kyǒnggi-do, South Korea, 15355
      • Korea University Ansan Hospital
  • Seoul-teukbyeolsi [Seoul]
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 05505
      • Asan Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 01812
      • National Medical Center
    • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 07441
      • Hallym University Kangnam Sacred Heart Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have chronic AD that has been present for ≥1 year before the screening period or have chronic eczema and meet the AAD criteria.
• Have moderate-to-severe AD, including all of the following at the baseline: EASI score ≥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 inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following:

  1. Inability to achieve good disease control, defined as mild disease or better after use of at least a medium-potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, whichever is 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 months preceding screening, such as cyclosporine, MTX, azathioprine, and MMF, will also be considered as surrogates for having inadequate response to topical therapy.
• Adolescents body weight must be ≥40 kg at baseline.
• Males may participate in this trial and comply with specific local government study requirements. Females of childbearing potential and females not of childbearing potential may participate in this trial.

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 require bursts of oral corticosteroids.
• Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment.
• Have had Serious, Opportunistic, Chronic and Recurring infection within 3 months prior to the screening or develops any of these infections before the randomization.
• Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has not been treated with a complete course of appropriate therapy or such treatment is underway.
• 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 been resected with no evidence of metastatic disease for 3 years, and
  2. cervical carcinoma in situ, with no evidence of recurrence within 5 years before screening visit.
• Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab every 2 weeks (Q2W); Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only lebrikizumab and combo cohort where lebrikizumab is in combination with TCS treatment.	Drug: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150; Drug: Topical Corticosteroid; Topical Corticosteroid
Experimental: Lebrikizumab every 4 weeks (Q4W); Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to the Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W from Week 16 until Week 48.	Drug: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150
Experimental: Escape Arm (Lebrikizumab Q2W); Maintenance Period (Week 16-Week 50): Participants who require rescue treatment for atopic dermatitis (AD) during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open label lebrikizumab Q2W from Week 16 through Week 50. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score <50% of baseline), will be eligible for the Escape Arm.	Drug: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150
Placebo Comparator: Placebo; Induction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only Placebo and combo cohort where Placebo is given in combination with topical corticosteroid (TCS) treatment. Maintenance Period (Week 16-Week 52): Participants of responders at Week 16 will receive single injection of placebo every 4 weeks (Q4W) from Week 16 until Week 48.	Drug: Placebo; Subcutaneous injection; Drug: Topical Corticosteroid; Topical Corticosteroid
Experimental: Lebrikizumab every 8 weeks (Q8W); Maintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to Lebrikizumab Q8W arm receive one lebrikizumab injection Q8W, with one placebo injection 4 weeks after each lebrikizumab injection from Week 16 until Week 48.	Drug: Lebrikizumab; Subcutaneous injection; Other Names: LY3650150

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification. when used in combination with TCS treatment.	Baseline, Week 16
Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort	The IGA measures the investigator's global assessment of the participant's overall severity of their AD, based on a static, numeric 5-point scale from 0 (clear skin) to 4 (severe disease). The score is based on an overall assessment of the degree of erythema, papulation/induration, oozing/crusting, and lichenification.	Baseline, Week 16
Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) for Mono Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score	Week 16
Percentage of Participants Achieving EASI-75 for Combo Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Itch NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."	Baseline, Week 16
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	Itch NRS is an 11-point scale used by participants to rate their worst itch severity over the past 24 hours with 0 indicating "No itch" and 10 indicating "Worst itch imaginable."	Baseline, Week 16
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) for Combo Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.	Week 16
Percentage Change From Baseline in EASI Score for Combo Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).	Baseline, Week 16
Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Combo Cohort	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable". Overall severity of a participant's itching is indicated by selecting the number that best describes the worst level of itching in the past 24 hours (Naegeli et al. 2015; Kimball et al. 2016; Newton et al. 2019; Silverberg et al. 2021). The Itch NRS assessment will be completed daily by the participant using a handheld device.	Baseline, Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) for Combo Cohort	The DLQI is a participant-reported, 10-item, quality-of-life questionnaire in those ≥16 years of age that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). The recall period of this scale is over the "last week." Response categories include "not at all," "a little", "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (or "not relevant") responses scored as 0. Scores range from 0 to 30 with higher scores indicating greater impairment of QoL. A DLQI total score of 0 to 1 is considered as having no effect on a participant's health related quality-of-life (HRQoL), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.	Baseline, Week 16
Percentage of Participants Achieving EASI-90 for Mono Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score	Week 16
Percentage Change From Baseline in EASI Score for Mono Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).	Week 16
Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Mono Cohort	The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable". Overall severity of a participant's itching is indicated by selecting the number that best describes the worst level of itching in the past 24 hours (Naegeli et al. 2015; Kimball et al. 2016; Newton et al. 2019; Silverberg et al. 2021). The Itch NRS assessment will be completed daily by the participant using a handheld device	Baseline, Week 16
Change from Baseline in Dermatology Life Quality Index (DLQI) for Mono Cohort	The DLQI is a participant-reported, 10-item, quality-of-life questionnaire in those ≥16 years of age that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). The recall period of this scale is over the "last week." Response categories include "not at all," "a little", "a lot," and "very much," with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (or "not relevant") responses scored as 0. Scores range from 0 to 30 with higher scores indicating greater impairment of QoL. A DLQI total score of 0 to 1 is considered as having no effect on a participant's health related quality-of-life (HRQoL), and a 4-point change from baseline is considered as the minimal clinically important difference threshold.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2024
• Primary Completion (Actual): September 25, 2025
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Dermatitis; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin and Connective Tissue Diseases; Dermatitis, Atopic; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; lebrikizumab; Adrenal Cortex Hormones
• Other Study ID Numbers: 18817; J2T-MC-KGBW (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes