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

Atopic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06280716
• Other study ID #: 18817
• Secondary ID: J2T-MC-KGBW
• Status: Recruiting
• Phase: Phase 3
• Start date: April 24, 2024
• Est. completion date: November 2026

Study information

• Verified date: June 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial 1-877-CTLILLY
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 430
• Est. completion date: November 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

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.

• 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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• Placebo
Subcutaneous injection
• Lebrikizumab
Subcutaneous injection
• Topical Corticosteroid
Topical Corticosteroid

Locations

Country	Name	City	State
China	Beijing Children's hospital, Capital Medical University	Beijing	Beijing
China	Beijing Friendship Hospital	Beijing	Beijing
China	Beijing Tongren Hospital affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Tsinghua Changgung Hospital	Beijing	Beijing
China	China-Japan Friendship Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	Hunan Children's Hospital	Changsha	Hunan
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital Central South University	Changsha	Hunan
China	West China Hospital, Sichuan University	Cheng Du	Sichuan
China	The Children's Hospital of Chongqing Medical University	Chongqing	Chongqing
China	The First Affiliated Hospital Of Fujian Medical University	Fuzhou
China	Guangdong Province Dermatology Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangdong
China	Hainan General Hospital	Haikou	Hainan
China	Sir Run Run Shaw Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University	Hangzhou	Zhejiang
China	The First People's Hospital of Hangzhou	Hangzhou	Zhejiang
China	Huashan Hospital Affiliated Fudan University	Shanghai	Shanghai
China	Shanghai Skin Disease Hospital	Shanghai
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Children's Hospital	Shenzhen	Guangdong
China	The University of Hong Kong-Shenzhen Hospital	Shenzhen	Guangdong
China	The First Hospital of Hebei Medical University	Shijiazhuang
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu
China	Children's Hospital of Shanxi	Taiyuan	Shanxi
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	The First Hospital of Wuhan	Wuhan	Hubei
China	Wuhan Union Hospital	Wuhan	Hubei
China	Wannan Medical College Yijishan Hospital	Wuhu	Anhui
China	Wuxi No.2 People's Hospital	Wuxi	Jiangsu
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'An	Shaanxi
China	Zhongshan Hospital Fudan University (Xiamen Branch)	Xiamen	Fujian
China	Zhejiang University School of Medicine - The Fourth Affiliated Hospital	Yiwu	Zhejiang
China	Affiliated Hospital of Jiangsu University	Zhenjiang	Jiangsu
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Kyonggi-do
Korea, Republic of	The Catholic University of Korea, Incheon St. Mary's Hospital	Bupyeong-gu	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Asan Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Hallym University Kangnam Sacred Heart Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	National Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Eczema Area and Severity Index (EASI-75) (=75% Reduction in EASI Score) at Week 16 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-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
Primary	Percentage of Participants Achieving EASI-75 at Week 16 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
Secondary	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	Percentage of Participants Achieving EASI-90 (=90% Reduction in EASI Score) at Week 16 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 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe).; The EASI-90 responder is defined as a participant who achieves a = 90% improvement from baseline in the EASI score.	Week 16
Secondary	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	Itch NRS is 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."	Baseline, Week 16
Secondary	Percentage Change From Baseline in EASI Score at Week 16 for Combo Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, 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).	Week 16
Secondary	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
Secondary	Percentage of Participants Achieving EASI-90 at Week 16 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-90 responder is defined as a participant who achieves a = 90% improvement from baseline in the EASI score	Week 16
Secondary	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	Itch NRS is 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."	Baseline, Week 16
Secondary	Percentage Change From Baseline in EASI Score at Week 16 for Mono Cohort	The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease, 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).	Week 16

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