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 From Baseline in EASI Score) at Week 16 (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab) | Week 16 | EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. The EASI-75 responder is defined as a participant who achieves a ≥ 75% reduction from baseline in the EASI score. |
| Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 and a Reduction of ≥2 Points From Baseline to Week 16 (Combo Cohort: Placebo + TCS Vs 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Vs 250 mg Lebrikizumab) | Baseline, Week 16 | The IGA measures the investigator's global assessment of the participant's overall severity of their Atopic Dermatitis. The IGA is comprised of a 5-point numeric scale ranging from 0 (clear skin) to 4 (severe disease) and a score is selected using descriptors that best describe the overall appearance of the lesions at a given time point. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Achieving Response of Eczema Area and Severity Index (EASI)-90 (≥90% Reduction From Baseline in EASI Score) at Week 16 (Combo Cohort: Placebo + TCS Vs 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Vs 250 mg Lebrikizumab) | Week 16 | EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. The EASI-90 responder is defined as a participant who achieves a ≥ 90% reduction from baseline in the EASI score. |
| Percentage of Participants Who Achieved a ≥4 Point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab) | Week 16 | Percentage of Participants who Achieved a ≥4 Point improvement in Itch NRS Score at Week 16 is reported. The Itch NRS is a 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." |
| Percent Change From Baseline in Itch Numeric Rating Scale (NRS) (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab) | Baseline, Week 16 | The Itch NRS is a 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". LS mean was calculated using MMRM model which includes: treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, age group, baseline IGA score and country. |
| Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab) | Baseline, Week 16 | The DLQI questionnaire is a 10-item, quality-of-life questionnaire (for participants \>=16 years) that covers 6 domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, treatment) to assess impact of skin disease on the quality of life of an affected person. 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. Questions are scored from 0 to 3, giving possible total score range from 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life). A high score is indicative of a poor quality of life. LS mean was calculated using MMRM model which includes :treatment, baseline value, visit, the interaction of the baseline value-by-visit, the interaction of treatment by-visit, age group, baseline IGA score and country. |
| Percent Change From Baseline in Total Eczema Area and Severity Index (Combo Cohort: Placebo + TCS Versus 250 mg Lebrikizumab + TCS; Mono Cohort: Placebo Versus 250 mg Lebrikizumab) | Baseline, Week 16 | EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs, by scoring the extent of disease (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 (erythema, edema/papulation, excoriation, and lichenification) each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head and neck, trunk, upper limbs, and lower limbs). Half scores are allowed. The final EASI score will be obtained by weight-averaging these 4 scores and will range from 0 to 72. A higher score represents greater disease severity. |
Countries
China, South Korea
Contacts
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 57 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 218 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 99 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 31 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 56 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 101 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 56 | 0 / 112 | 0 / 44 | 0 / 89 |
| other Total, other adverse events | 26 / 56 | 31 / 112 | 14 / 44 | 31 / 89 |
| serious Total, serious adverse events | 1 / 56 | 3 / 112 | 1 / 44 | 0 / 89 |
Outcome results
None listed