The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy. Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Administered SC
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline
The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.
Time frame: Week 16
Percentage of Participants Achieving EASI-75
Time frame: Baseline to Week 24
Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS
Time frame: Baseline to Week 24
Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline
Time frame: Baseline to Week 24
Percentage of Participants Achieving EASI-90
Time frame: Baseline to Week 24
Change from Baseline in Body Surface Area (BSA) Involvement
Time frame: Baseline, Week 24
Percentage of Change from Baseline in Pruritus NRS Score
Time frame: Baseline, Week 24
Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction
Time frame: Baseline to Week 24
Percentage Change from Baseline in Sleep-loss Scale
Time frame: Baseline, Week 24
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
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Total Skin & Beauty Dermatology Center, PC DBA Total Dermatology
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Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction
Time frame: Baseline to Week 24
Change from Baseline in Dermatology Quality of Life (DLQI)
Time frame: Baseline, Week 24
Change from Baseline in Children's Dermatology Quality of Life (CDLQI)
Time frame: Baseline, Week 24