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

Phase 3
Recruiting
Conditions
Atopic Dermatitis
Interventions
Drug: Lebrikizumab
Drug: Placebo
Drug: Topical Corticosteroid
Registration Number
NCT06280716
Lead Sponsor
Eli Lilly and Company
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
430
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.

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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.

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Lebrikizumab every 2 weeks (Q2W)Topical CorticosteroidInduction Period (Baseline-Week 16): Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only lebrikizumab and combo cohort where lebrikizumab is in combination with TCS treatment.
Lebrikizumab every 4 weeks (Q4W)LebrikizumabMaintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to the Lebrikizumab Q4W arm receive one lebrikizumab injection Q4W from Week 16 until Week 48.
PlaceboTopical CorticosteroidInduction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only Placebo and combo cohort where Placebo is given in combination with topical corticosteroid (TCS) treatment. Maintenance Period (Week 16-Week 52): Participants of responders at Week 16 will receive single injection of placebo every 4 weeks (Q4W) from Week 16 until Week 48.
Lebrikizumab every 8 weeks (Q8W)LebrikizumabMaintenance Period (Week 16-Week 52): Treatment from Week 16 to Week 52 is based on re-randomization of responders (from lebrikizumab Q2W arm) in the Induction Period. Participants re-randomized to Lebrikizumab Q8W arm receive one lebrikizumab injection Q8W, with one placebo injection 4 weeks after each lebikizumab injection from Week 16 until Week 48.
Escape Arm (Lebrikizumab Q2W)LebrikizumabMaintenance Period (Week 16-Week 50): Participants who require rescue treatment for atopic dermatitis (AD) during the Induction Period, or are non-responders at Week 16, will be eligible for treatment in an Escape Arm where participants will receive open label lebrikizumab Q2W from Week 16 through Week 50. In addition, participants who do not maintain an acceptable response during the Maintenance Period (have an EASI score \<50% of baseline), will be eligible for the Escape Arm.
PlaceboPlaceboInduction Period (Baseline-Week 16): Two subcutaneous (SC) injections of Placebo as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only Placebo and combo cohort where Placebo is given in combination with topical corticosteroid (TCS) treatment. Maintenance Period (Week 16-Week 52): Participants of responders at Week 16 will receive single injection of placebo every 4 weeks (Q4W) from Week 16 until Week 48.
Lebrikizumab every 2 weeks (Q2W)LebrikizumabInduction Period (Baseline-Week 16): Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection every 2 weeks (Q2W) from Week 4 until Week 14. Induction period includes mono cohort with only lebrikizumab and combo cohort where lebrikizumab is in combination with TCS treatment.
Primary Outcome Measures
NameTimeMethod
Percentage of Participants Achieving EASI-75 at Week 16 for Combo CohortWeek 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 Eczema Area and Severity Index (EASI-75) (≥75% Reduction in EASI Score) at Week 16 for Mono CohortWeek 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

Secondary Outcome Measures
NameTimeMethod
Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Combo CohortBaseline, 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.

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 CohortBaseline, Week 16

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."

Percentage Change From Baseline in EASI Score at Week 16 for Combo CohortWeek 16

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).

Percentage of Participants Achieving IGA Score of 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 for Mono CohortBaseline, 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 EASI-90 (≥90% Reduction in EASI Score) at Week 16 for Combo CohortWeek 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-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score.

Percentage of Participants Achieving EASI-90 at Week 16 for Mono CohortWeek 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-90 responder is defined as a participant who achieves a ≥ 90% improvement from baseline in the EASI score

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 CohortBaseline, Week 16

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."

Percentage Change From Baseline in EASI Score at Week 16 for Mono CohortWeek 16

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).

Trial Locations

Locations (47)

Wannan Medical College Yijishan Hospital

🇨🇳

Wuhu, Anhui, China

China-Japan Friendship Hospital

🇨🇳

Beijing, Beijing, China

Peking University People's Hospital

🇨🇳

Beijing, Beijing, China

Beijing Children's hospital, Capital Medical University

🇨🇳

Beijing, Beijing, China

Beijing Friendship Hospital Affiliate of Capital University

🇨🇳

Beijing, Beijing, China

Peking University Third Hospital

🇨🇳

Beijing, Beijing, China

Beijing Tongren Hospital affiliated to Capital Medical University

🇨🇳

Beijing, Beijing, China

Beijing Tsinghua Changgung Hospital

🇨🇳

Beijing, Beijing, China

The Children's Hospital of Chongqing Medical University

🇨🇳

Chongqing, Chongqing, China

Zhongshan Hospital Fudan University (Xiamen Branch)

🇨🇳

Xiamen, Fujian, China

Guangdong Province Dermatology Hospital

🇨🇳

Guangzhou, Guangdong, China

The First Affiliated Hospital, Sun Yat-sen University

🇨🇳

Guangzhou, Guangdong, China

Shenzhen Children's Hospital

🇨🇳

Shenzhen, Guangdong, China

Peking University Shenzhen Hospital

🇨🇳

Shenzhen, Guangdong, China

The University of Hong Kong-Shenzhen Hospital

🇨🇳

Shenzhen, Guangdong, China

Hainan General Hospital

🇨🇳

Haikou, Hainan, China

The First Hospital of Wuhan

🇨🇳

Wuhan, Hubei, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

🇨🇳

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

🇨🇳

Wuhan, Hubei, China

Hunan Children's Hospital

🇨🇳

Changsha, Hunan, China

Xiangya Hospital Central South University

🇨🇳

Changsha, Hunan, China

The Second Xiangya Hospital of Central South University

🇨🇳

Changsha, Hunan, China

The First Affiliated Hospital of Soochow University

🇨🇳

Suzhou, Jiangsu, China

Wuxi No.2 People's Hospital

🇨🇳

Wuxi, Jiangsu, China

Affiliated Hospital of Jiangsu University

🇨🇳

Zhenjiang, Jiangsu, China

The Second Hospital of Jilin University

🇨🇳

Changchun, Jilin, China

The First Hospital of Jilin University

🇨🇳

Changchun, Jilin, China

The Second Affiliated Hospital of Xi'an Jiaotong University

🇨🇳

Xi'An, Shaanxi, China

Shanghai Sixth People's Hospital

🇨🇳

Shanghai, Shanghai, China

Huashan Hospital, Fudan University

🇨🇳

Shanghai, Shanghai, China

Shanghai Children's Hospital

🇨🇳

Shanghai, Shanghai, China

Shanghai Tenth People's Hospital

🇨🇳

Shanghai, Shanghai, China

Children's Hospital of Shanxi

🇨🇳

Taiyuan, Shanxi, China

West China Hospital, Sichuan University

🇨🇳

Cheng Du, Sichuan, China

Tianjin Medical University General Hospital

🇨🇳

Tianjin, Tianjin, China

The First People's Hospital of Hangzhou

🇨🇳

Hangzhou, Zhejiang, China

The first Affiliated Hospital, Zhejiang University School of Medicine

🇨🇳

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

🇨🇳

Hangzhou, Zhejiang, China

Zhejiang University School of Medicine - The Fourth Affiliated Hospital

🇨🇳

Yiwu, Zhejiang, China

The First Affiliated Hospital Of Fujian Medical University

🇨🇳

Fuzhou, China

Shanghai Skin Disease Hospital

🇨🇳

Shanghai, China

The First Hospital of Hebei Medical University

🇨🇳

Shijiazhuang, China

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

🇰🇷

Bupyeong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of

Korea University Ansan Hospital

🇰🇷

Ansan-si, Kyǒnggi-do, Korea, Republic of

National Medical Center

🇰🇷

Seoul, Seoul-teukbyeolsi [Seoul], 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

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