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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
377
Percentage of Participants with an Investigator Global Assessment (IGA) score 0 or 1 and a Reduction ≥2 points from Baseline
EASI-75 is a co-primary endpoint with IGA.
Time frame: Baseline to Week 16
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) ≥75% Reduction from Baseline in EASI Score
IGA is a co-primary endpoint with EASI-75.
Time frame: Baseline to Week 16
Percentage of Participants Achieving EASI-90, a ≥90% Reduction from Baseline in EASI Score
Time frame: 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
Time frame: 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
Time frame: Baseline to Week 16
Percentage Change from Baseline in EASI Score
Time frame: Baseline, Week 16
Percentage Change from Baseline in Pruritus NRS Score
Time frame: Baseline, Week 16
Change from Baseline in Children Dermatology Life Quality Index (cDLQI)
Time frame: Baseline, Week 16
Mean Change from Baseline in Worst Scratch/Itch Numeric Rating Score (WSI-NRS)
Time frame: Baseline, Week 16
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Clinical Research Center of Alabama
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Arkansas Research Trials
North Little Rock, Arkansas, United States
First OC Dermatology
Fountain Valley, California, United States
Antelope Valley Clinical Trials
Lancaster, California, United States
Dermatology Research Associates
Los Angeles, California, United States
Integrative Skin Science and Research
Sacramento, California, United States
Rady's Children Hospital San Diego - Dermatology
San Diego, California, United States
UConn Health
Farmington, Connecticut, United States
Solutions Through Advanced Research
Jacksonville, Florida, United States
...and 75 more locations
Change from Baseline in Body Surface Area (BSA)
Time frame: Baseline, Week 16
Percentage Change from Baseline in Scoring Atopic Dermatitis (SCORAD)
Time frame: Baseline, Week 16
Percentage of Participants Achieving EASI-50, a ≥50% Reduction from Baseline in EASI Score
Time frame: Baseline to Week 16
Pharmacokinetics (PK): Average Serum Lebrikizumab Concentration
Time frame: Week 14
Percentage of Participants with Positive Responses by the Modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ)
Time frame: 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
Time frame: Baseline to Week 16
Change from Baseline in SCORAD
Time frame: Baseline, Week 16