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Atopic DermatitisPhase 3NCT06280716

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

A Phase 3 study testing Lebrikizumab and Topical Corticosteroid in people with Atopic Dermatitis, run by Eli Lilly and Company at 46 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Atopic Dermatitis
What is being tested?
Lebrikizumab and Topical Corticosteroid
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
301 participants
Where
46 sitesin 2 countries
Study dates
24 Apr 2024to 16 Jul 2026
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

China41 sites

  • China-Japan Friendship Hospital

    Beijing, Beijing Municipality, 100029

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100034

  • Beijing Children's hospital, Capital Medical University

    Beijing, Beijing Municipality, 100045

  • Beijing Friendship Hospital Affiliate of Capital University

    Beijing, Beijing Municipality, 100050

  • Peking University Third Hospital

    Beijing, Beijing Municipality, 100091

  • Beijing Tongren Hospital affiliated to Capital Medical University

    Beijing, Beijing Municipality, 100730

  • Beijing Tsinghua Changgung Hospital

    Beijing, Beijing Municipality, 102202

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130000

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Hunan Children's Hospital

    Changsha, Hunan, 410007

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Children's Hospital of Chongqing Medical University

    Chongqing, Chongqing Municipality, 400065

  • The First Affiliated Hospital Of Fujian Medical University

    Fuzhou, 350005

  • Guangdong Province Dermatology Hospital

    Guangzhou, Guangdong, 510018

  • The First Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510180

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • The First People's Hospital of Hangzhou

    Hangzhou, Zhejiang, 310000

  • The first Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310003

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

    Hangzhou, Zhejiang, 310016

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200030

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200040

  • Shanghai Tenth People's Hospital

    Shanghai, Shanghai Municipality, 200072

  • Shanghai Skin Disease Hospital

    Shanghai, 200071

  • Shenzhen Children's Hospital

    Shenzhen, Guangdong, 518026

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong, 518036

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • The First Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050031

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

  • Children's Hospital of Shanxi

    Taiyuan, Shanxi, 030013

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300052

  • The First Hospital of Wuhan

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430022

  • Renmin Hospital of Wuhan University

    Wuhan, Hubei, 430060

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • Wuxi No.2 People's Hospital

    Wuxi, Jiangsu, 214000

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi, 710004

  • Zhongshan Hospital Fudan University (Xiamen Branch)

    Xiamen, Fujian, 361015

  • Zhejiang University School of Medicine - The Fourth Affiliated Hospital

    Yiwu, Zhejiang, 322000

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

South Korea5 sites

  • Korea University Ansan Hospital

    Ansan-si, Kyǒnggi-do, 15355

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

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

  • National Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 01812

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 05505

  • Hallym University Kangnam Sacred Heart Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 07441

Other trials in South Korea

About this study

Official title: 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.

Being tested
Placebo, Lebrikizumab, Topical Corticosteroid
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Subcutaneous injection

  • LebrikizumabDrug

    Also called LY3650150

    Subcutaneous injection

  • Topical CorticosteroidDrug

    Topical Corticosteroid

Study groups in NCT06280716
Study groupRoleWhat they receive
Combo Cohort: Placebo + TCSPlacebo comparatorParticipants received Placebo injection subcutaneously administered every 2 weeks (Q2W) in combination with topical corticosteroid (TCS) up to Week 16.
Receives: Drug: Placebo; Drug: Topical Corticosteroid
Combo Cohort: 250 mg Lebrikizumab + TCSExperimentalParticipant received 250 mg (milligrams) Lebrikizumab injection subcutaneously administered Q2W in combination with TCS up to Week 16.
Receives: Drug: Lebrikizumab
Mono Cohort: 250 mg LebrikizumabExperimentalParticipant received 250 mg Lebrikizumab injection subcutaneously administered Q2W up to Week 16.
Receives: Drug: Lebrikizumab
Mono Cohort: PlaceboPlacebo comparatorParticipant received Placebo injection subcutaneously administered Q2W up to Week 16.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving Eczema Area and Severity Index (EASI)-75 (≥75% Reduction From Baseline in EASI Score) at Week 16 (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab)

    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score.

    Measured: Week 16

  2. Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 (Combo Cohort: Placebo + TCS Vs 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Vs 250 mg Lebrikizumab)

    The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point.

    Measured: Baseline, Week 16

Secondary outcomes (5)

  1. Percentage of Participants Achieving Response of Eczema Area and Severity Index (EASI)-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 (Combo Cohort: Placebo + TCS Vs 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Vs 250 mg Lebrikizumab)

    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score.

    Measured: Week 16

  2. Percentage of Participants Who Achieved a ≥4 Point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab)

    Percentage of Participants who Achieved a ≥4 Point improvement in Itch NRS Score at Week 16 is reported.

    The Itch NRS is a 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."

    Measured: Week 16

  3. Percent Change From Baseline in Itch Numeric Rating Scale (NRS) (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab)

    The Itch NRS is a 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".

    LS mean was calculated using MMRM model which includes: treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, age group, baseline IGA score and country.

    Measured: Baseline, Week 16

  4. Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab)

    The DLQI questionnaire is a 10-item, quality-of-life questionnaire (for participants >=16 years) that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) to assess impact of skin disease on the quality of life of an affected person. 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. Questions are scored from 0 to 3, giving possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life.

    LS mean was calculated using MMRM model which includes :treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, age group, baseline IGA score and country.

    Measured: Baseline, Week 16

  5. Percent Change From Baseline in Total Eczema Area and Severity Index (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab)

    EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity.

    Measured: Baseline, Week 16

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start24 Apr 2024
  3. Primary completion25 Sep 2025
  4. Study completion16 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, parallel group, placebo controlled
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280716
Sponsor's protocol ID
18817
Other IDs
J2T-MC-KGBW
Status last verified
Sep 2026
First submitted
20 Feb 2024
Last updated
16 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

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