A Phase 3, 2-Part, Open-Label and Double-Blind, Randomised Study to Evaluate the Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis

Atopic Dermatitis

PART 1 Percentage of participants achieving EASI score ≤7 at Week 24 PART 2 • Percentage of participants achieving EASI 75 at Week 36 • Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points from baseline (Part 1) at Week 36

PART 1: Time to EASI score ≤7, PART 1: Percentage of participants achieving EASI ≤5, and EASI ≤3 at Week 24, PART 1: Percentage of participants achieving EASI 75 and EASI 90 at Week 24, PART 1: Percentage of participants with an IGA score of 0 or 1 and a reduction ≥2 points at Week 24, PART 1: Percentage of participants achieving SCORAD 75 and SCORAD 90 at Week 24, PART 1: Percentage change in mTLSS (hands) from baseline at Week 24 , in participants with AD of the hands at baseline, PART 1: Pruritus: Percentage of participants with Pruritus NRS ≥4 at baseline achieving ≥4-point improvement in Pruritus NRS from baseline at Week 24, PART 1: Quality of Life: Percentage of participants achieving DLQI/cDLQI 0-1 at Week 24, PART 1: Quality of Life: Percentage of participants with DLQI ≥4 at baseline achieving ≥4 point improvement in DLQI from baseline at Week 24, PART 1: Quality of Life: Percentage of participants with cDLQI ≥6 at baseline achieving ≥6 point improvement in cDLQI from baseline at Week 24, PART 1: Sleep Loss Due to Itch: Percentage of participants with a Sleep-Loss Scale of ≥2 points at baseline achieving ≥2-point improvement at Week 24, PART 1: Disease Control: Percentage of participants with POEM ≥4 at baseline achieving ≥4 point improvement in POEM from baseline at Week 24, PART 2: Percentage of participants achieving EASI scores ≤7 and ≤3 at Week 36, PART 2: Percentage of participants achieving EASI 90 at Week 36, PART 2: Percentage of participants with pruritus NRS ≥4 at baseline (Part 1) achieving ≥4-point improvement in Pruritus NRS at Week 36, PART 2: Pruritus: Percentage of participants with pruritus NRS 0 or 1 at Week 36, PART 2: Quality of Life: Percentage of participants achieving DLQI/cDLQI 0 or 1 at Week 36, PART 2: Quality of Life: Percentage of participants with DLQI ≥4 at baseline (Part 1) achieving ≥4 point improvement in DLQI at Week 36, PART 2: Quality of Life: Percentage of participants with cDLQI ≥6 at baseline (Part 1) achieving ≥6 point improvement in cDLQI at Week 36, PART 2: Sleep Loss Due to Itch: Percentage of participants with a Sleep-Loss Scale of ≥2 points at baseline (Part 1) achieving ≥2-point improvement at Week 36, PART 2: Disease Control: Percentage of participants with POEM ≥4 at baseline (Part 1) achieving ≥4 point improvement in POEM at Week 36

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