Atopic Dermatitis, Eczema
Conditions
Brief summary
The main purpose of this study is to measure the effect, safety and how well the body absorbs lebrikizumab in pediatric participants 6 months to \<18 years of age with moderate-to-severe atopic dermatitis (AD).
Interventions
DRUGLebrikizumab
Administered SC
DRUGPlacebo
Placebo given SC
TCS administered
Sponsors
Eli Lilly and Company
Dermira, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Months to 17 Years
Healthy volunteers
No
Inclusion criteria
* Have a diagnosis of AD prior to screening as stated in the criteria by the American Academy of Dermatology for at least, * 12 months if participants are ≥6 years of age * 6 months if participants are 2 to \<6 years of age * 3 months if participants are 6 months to \<2 years of age. * Have an EASI score ≥16 at the screening and baseline * Have an IGA score ≥3 (scale of 0 to 4) at the screening and baseline * Have ≥10% BSA of AD involvement at the screening and baseline.
Exclusion criteria
* Are currently enrolled or have participated within the last 8 weeks in a clinical study involving an investigational intervention or any other type of medical research judged not to be scientifically or medically compatible with this study. * Treatment with the following prior to the baseline: * An investigational drug within 8 weeks or less than 5 half-lives, whichever is longer. * Dupilumab within 8 weeks. Note: The enrollment of participants with prior use of Dupilumab will be limited to \<20%. * Treatment with a topical investigational drug within 2 weeks prior to the baseline. * Have received a Bacillus Calmette-Guerin vaccination or treatment within less than 4 weeks before randomization.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline | Baseline to Week 16 | EASI-75 is a co-primary endpoint with IGA. |
| Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score | Baseline to Week 16 | IGA is a co-primary endpoint with EASI-75. |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline in Children Dermatology Life Quality Index (cDLQI) | Baseline, Week 16 |
| Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS) | Baseline, Week 16 |
| Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score | Baseline to Week 16 |
| Percentage of Participants with a Pruritus Numeric Rating Score (NRS) of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline | Baseline to Week 16 |
| Percentage of Participants with a cDLQI of ≥6 points at Baseline Achieving ≥6-point Improvement in cDLQI from Baseline to Week 16 | Baseline to Week 16 |
| Percentage Change from Baseline in EASI Score | Baseline, Week 16 |
| Percentage Change from Baseline in Pruritus NRS Score | Baseline, Week 16 |
| Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score | Baseline to Week 16 |
| Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration | Week 14 |
| Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) | Week 14 |
| Percentage of Participants with a Worst Scratching/Itching NRS of ≥4 points at Baseline Who Achieve a ≥4-point Reduction from Baseline to Week 16 | Baseline to Week 16 |
| Change from Baseline in Body Surface Area (BSA) | Baseline, Week 16 |
| Change from Baseline in SCORAD | Baseline, Week 16 |
| Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD) | Baseline, Week 16 |
Countries
Argentina, Australia, Brazil, Canada, Czechia, Germany, Japan, Mexico, Poland, Spain, Taiwan, United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed