A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis (NCT06280716) — Japan Trial Details

Condition(s) studied

Atopic Dermatitis

Investigational drug(s) / intervention(s)

PlaceboLebrikizumab →Topical Corticosteroid

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

Sex

ALL

Min age

12 Years

Max age

—

Healthy volunteers

No

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
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.

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