Clinical Trials in South Korea / NCT06280716
Active, not recruiting
Phase 3
A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis
NCT06280716 · tracked via the Priya Life Science South Korea tracker
Condition(s) studied
Atopic Dermatitis
Investigational drug(s) / intervention(s)
Placebo: Subcutaneous injection
Lebrikizumab: Subcutaneous injection
Topical Corticosteroid: Topical Corticosteroid
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
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.
Primary outcome measure(s)
- Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) for Mono Cohort — Week 16
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 - Percentage of Participants Achieving EASI-75 for Combo Cohort — Week 16
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. - Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort — Baseline, Week 16
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. - Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort — Baseline, Week 16
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.
Trial sites (46)
| Facility | City | Region | Status |
|---|---|---|---|
| Wannan Medical College Yijishan Hospital | Wuhu | Anhui | |
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | |
| Peking University People's Hospital | Beijing | Beijing Municipality | |
| Beijing Children's hospital, Capital Medical University | Beijing | Beijing Municipality | |
| Beijing Friendship Hospital Affiliate of Capital University | Beijing | Beijing Municipality | |
| Peking University Third Hospital | Beijing | Beijing Municipality | |
| Beijing Tongren Hospital affiliated to Capital Medical University | Beijing | Beijing Municipality | |
| Beijing Tsinghua Changgung Hospital | Beijing | Beijing Municipality | |
| The Children's Hospital of Chongqing Medical University | Chongqing | Chongqing Municipality | |
| Zhongshan Hospital Fudan University (Xiamen Branch) | Xiamen | Fujian | |
| Guangdong Province Dermatology Hospital | Guangzhou | Guangdong | |
| The First Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | |
| Shenzhen Children's Hospital | Shenzhen | Guangdong | |
| Peking University Shenzhen Hospital | Shenzhen | Guangdong | |
| The University of Hong Kong-Shenzhen Hospital | Shenzhen | Guangdong | |
| Hainan General Hospital | Haikou | Hainan | |
| The First Hospital of Hebei Medical University | Shijiazhuang | Hebei | |
| The First Hospital of Wuhan | Wuhan | Hubei | |
| Union Hospital Tongji Medical College Huazhong University of Science and Technology | Wuhan | Hubei | |
| Renmin Hospital of Wuhan University | Wuhan | Hubei | |
| Hunan Children's Hospital | Changsha | Hunan | |
| Xiangya Hospital Central South University | Changsha | Hunan | |
| The Second Xiangya Hospital of Central South University | Changsha | Hunan | |
| The First Affiliated Hospital of Soochow University | Suzhou | Jiangsu | |
| Wuxi No.2 People's Hospital | Wuxi | Jiangsu | |
| Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | |
| The Second Hospital of Jilin University | Changchun | Jilin | |
| The First Hospital of Jilin University | Changchun | Jilin | |
| The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | |
| Shanghai Sixth People's Hospital | Shanghai | Shanghai Municipality | |
| Huashan Hospital, Fudan University | Shanghai | Shanghai Municipality | |
| Shanghai Tenth People's Hospital | Shanghai | Shanghai Municipality | |
| Children's Hospital of Shanxi | Taiyuan | Shanxi | |
| West China Hospital, Sichuan University | Chengdu | Sichuan | |
| Tianjin Medical University General Hospital | Tianjin | Tianjin Municipality | |
| The First People's Hospital of Hangzhou | Hangzhou | Zhejiang | |
| The first Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Sir Run Run Shaw Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang | |
| Zhejiang University School of Medicine - The Fourth Affiliated Hospital | Yiwu | Zhejiang | |
| The First Affiliated Hospital Of Fujian Medical University | Fuzhou | China |
+ 6 more sites — see the full list on the official registry below.
More Eli Lilly and Company trials in South Korea
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06280716 on ClinicalTrials.gov ↗ ← All trials in South Korea