Clinical trial NCT06280716: A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Atopic Dermatitis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 430
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, parallel group, placebo controlled
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 outcomes:
measure: Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) for Mono Cohort
timeFrame: Week 16
measure: Percentage of Participants Achieving EASI-75 for Combo Cohort
timeFrame: Week 16
measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono Cohort
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo Cohort
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) for Combo Cohort
timeFrame: Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in EASI Score for Combo Cohort
timeFrame: Baseline, Week 16
measure: Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Combo Cohort
timeFrame: Baseline, Week 16
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) for Combo Cohort
timeFrame: Baseline, Week 16
measure: Percentage of Participants Achieving EASI-90 for Mono Cohort
timeFrame: Week 16
measure: 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
timeFrame: Baseline, Week 16
measure: Percentage Change From Baseline in EASI Score for Mono Cohort
timeFrame: Week 16
measure: Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Mono Cohort
timeFrame: Baseline, Week 16
measure: Change from Baseline in Dermatology Life Quality Index (DLQI) for Mono Cohort
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
city: Wuhu
country: China
facility: Wannan Medical College Yijishan Hospital
state: Anhui
city: Beijing
country: China
facility: China-Japan Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Children's hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Friendship Hospital Affiliate of Capital University
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital affiliated to Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital
state: Beijing
city: Chongqing
country: China
facility: The Children's Hospital of Chongqing Medical University
state: Chongqing
city: Xiamen
country: China
facility: Zhongshan Hospital Fudan University (Xiamen Branch)
state: Fujian
city: Guangzhou
country: China
facility: Guangdong Province Dermatology Hospital
state: Guangdong
city: Guangzhou
country: China
facility: The First Affiliated Hospital, Sun Yat-sen University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Children's Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
state: Guangdong
city: Shenzhen
country: China
facility: The University of Hong Kong-Shenzhen Hospital
state: Guangdong
city: Haikou
country: China
facility: Hainan General Hospital
state: Hainan
city: Wuhan
country: China
facility: The First Hospital of Wuhan
state: Hubei
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
state: Hubei
city: Changsha
country: China
facility: Hunan Children's Hospital
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University
state: Jiangsu
city: Wuxi
country: China
facility: Wuxi No.2 People's Hospital
state: Jiangsu
city: Zhenjiang
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'An
country: China
facility: The Second Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Taiyuan
country: China
facility: Children's Hospital of Shanxi
state: Shanxi
city: Cheng Du
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Hangzhou
country: China
facility: The First People's Hospital of Hangzhou
state: Zhejiang
city: Hangzhou
country: China
facility: The first Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Yiwu
country: China
facility: Zhejiang University School of Medicine - The Fourth Affiliated Hospital
state: Zhejiang
city: Fuzhou
country: China
facility: The First Affiliated Hospital Of Fujian Medical University
city: Shanghai
country: China
facility: Shanghai Skin Disease Hospital
city: Shijiazhuang
country: China
facility: The First Hospital of Hebei Medical University
city: Bupyeong-gu
country: Korea, Republic of
facility: The Catholic University of Korea, Incheon St. Mary's Hospital
state: Incheon-gwangyeoksi [Incheon]
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Kyǒnggi-do
city: Seoul
country: Korea, Republic of
facility: National Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul-teukbyeolsi [Seoul]
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
state: Seoul-teukbyeolsi [Seoul]
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: