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

NCT06280716 | Active Not Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 18817J2T-MC-KGBW
• Study Type: interventional
• Target: 301
• Locations: 2 countries
• Sites: 46

Brief 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.

Conditions

Atopic Dermatitis

Outcome Measures

Primary Outcomes (4)

• 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

• 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 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

Secondary Outcomes (10)

• Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) for Combo Cohort

  Week 16

• 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

  Baseline, Week 16

• Percentage Change From Baseline in EASI Score for Combo Cohort

  Baseline, Week 16

• Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Combo Cohort

  Baseline, Week 16

• Change from Baseline in Dermatology Life Quality Index (DLQI) for Combo Cohort

  Baseline, Week 16

Study Arms (5)

Lebrikizumab every 2 weeks (Q2W)

EXPERIMENTAL

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; Drug: Topical Corticosteroid

Lebrikizumab every 4 weeks (Q4W)

EXPERIMENTAL

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

Lebrikizumab every 8 weeks (Q8W)

EXPERIMENTAL

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

Escape Arm (Lebrikizumab Q2W)

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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; Drug: Topical Corticosteroid

Interventions

Placebo DRUG

Subcutaneous injection

Placebo

Lebrikizumab DRUG

Subcutaneous injection

Also known as: LY3650150

Escape Arm (Lebrikizumab Q2W); Lebrikizumab every 2 weeks (Q2W); Lebrikizumab every 4 weeks (Q4W); Lebrikizumab every 8 weeks (Q8W)

Topical Corticosteroid DRUG

Topical Corticosteroid

Lebrikizumab every 2 weeks (Q2W); Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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.
• 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.

You may not qualify if:

• 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:
• basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and
• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (46)

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241001, China

Location

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

Location

Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China

Location

Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China

Location

Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, 100050, China

Location

Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China

Location

Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102202, China

Location

The Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400065, China

Location

Zhongshan Hospital Fudan University (Xiamen Branch)

Xiamen, Fujian, 361015, China

Location

Guangdong Province Dermatology Hospital

Guangzhou, Guangdong, 510018, China

Location

The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510180, China

Location

Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China

Location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China

Location

The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China

Location

Hainan General Hospital

Haikou, Hainan, 570311, China

Location

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China

Location

The First Hospital of Wuhan

Wuhan, Hubei, 430022, China

Location

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China

Location

Hunan Children's Hospital

Changsha, Hunan, 410007, China

Location

Xiangya Hospital Central South University

Changsha, Hunan, 410008, China

Location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Wuxi No.2 People's Hospital

Wuxi, Jiangsu, 214000, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

The First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China

Location

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

Location

Children's Hospital of Shanxi

Taiyuan, Shanxi, 030013, China

Location

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310000, China

Location

The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China

Location

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China

Location

Zhejiang University School of Medicine - The Fourth Affiliated Hospital

Yiwu, Zhejiang, 322000, China

Location

The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350005, China

Location

Shanghai Skin Disease Hospital

Shanghai, 200071, China

Location

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

Bupyeong-gu, Incheon-gwangyeoksi [Incheon], 21431, South Korea

Location

Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, 15355, South Korea

Location

National Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 01812, South Korea

Location

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea

Location

Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea

Location

Related Links

• Related Info

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

lebrikizumab; Adrenal Cortex Hormones

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, parallel group, placebo controlled

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start: April 24, 2024
• Primary Completion: September 25, 2025
• Study Completion (Estimated): August 1, 2026
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement

Locations

CN (41); KR (5)