Atopic Dermatitis
Conditions
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.
Interventions
DRUGPlacebo
Subcutaneous injection
DRUGLebrikizumab
Subcutaneous injection
Topical Corticosteroid
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Double
Intervention model description
Randomized, double-blind, parallel group, placebo controlled
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Dermatology Life Quality Index (DLQI) for Combo Cohort | Baseline, Week 16 | The DLQI is a participant-reported, 10-item, quality-of-life questionnaire in those ≥16 years of age that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). The recall period of this scale is over the last week. Response categories include not at all, a little, a lot, and very much, with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (or not relevant) responses scored as 0. Scores range from 0 to 30 with higher scores indicating greater impairment of QoL. A DLQI total score of 0 to 1 is considered as having no effect on a participant's health related quality-of-life (HRQoL), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. |
| Percentage of Participants Achieving EASI-90 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-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 Cohort | Baseline, 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 of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) 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 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. |
| Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Mono Cohort | Baseline, Week 16 | The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching is indicated by selecting the number that best describes the worst level of itching in the past 24 hours (Naegeli et al. 2015; Kimball et al. 2016; Newton et al. 2019; Silverberg et al. 2021). The Itch NRS assessment will be completed daily by the participant using a handheld device |
| Change from Baseline in Dermatology Life Quality Index (DLQI) for Mono Cohort | Baseline, Week 16 | The DLQI is a participant-reported, 10-item, quality-of-life questionnaire in those ≥16 years of age that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). The recall period of this scale is over the last week. Response categories include not at all, a little, a lot, and very much, with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (or not relevant) responses scored as 0. Scores range from 0 to 30 with higher scores indicating greater impairment of QoL. A DLQI total score of 0 to 1 is considered as having no effect on a participant's health related quality-of-life (HRQoL), and a 4-point change from baseline is considered as the minimal clinically important difference threshold. |
| Percentage Change From Baseline in EASI Score for Mono Cohort | Week 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 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 | Baseline, 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 for Combo Cohort | Baseline, Week 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). |
| Percent Change from Baseline in Itch Numeric Rating Scale (NRS) for Combo Cohort | Baseline, Week 16 | The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing no itch and 10 representing worst itch imaginable. Overall severity of a participant's itching is indicated by selecting the number that best describes the worst level of itching in the past 24 hours (Naegeli et al. 2015; Kimball et al. 2016; Newton et al. 2019; Silverberg et al. 2021). The Itch NRS assessment will be completed daily by the participant using a handheld device. |
Countries
China, South Korea
Outcome results
None listed