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
The main purpose of this study is to evaluate the effectiveness of 24 weeks of lebrikizumab in improving disease severity, signs, and symptoms in adults and adolescents with moderate-to-severe AD in Part 1 and to describe how similar is the current maintenance dosing regimen of lebrikizumab 250 mg every 4 weeks (Q4W) to the new proposed; lebrikizumab 500 mg every 12 weeks (Q12W), in terms of efficacy, safety, PK, ADA and blood biomarkers.
‣ Part 1:
• Adults and adolescents (aged greater than or equal to \[\>=\] 12 to less than \[\<\] 18 at the time of informed consent form \[ICF\]/informed assent form \[IAF\] signature and weighing 40 \>= kilograms \[kg\]) who are candidates for systemic AD therapy.
• Chronic AD (according to Hanifin and Rajka Criteria (Hanifin 1980)) that has been present for \>= 1 year before the screening visit.
• EASI score \>= 12 at the Day 1/Baseline Visit.
• IGA score \>= 3 (moderate) (scale of 0 \[clear\] to 4 \[severe\]) at the Day 1/Baseline visit.
• \>= 10% BSA of AD involvement at the Day 1/Baseline visit.
• History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
• Completed electronic diary (eDiary) entries for pruritus and sleep-loss for a minimum of 4 of 7 days before Day 1/Baseline.
• Willing and able to comply with all clinic visits and study-related procedures and questionnaires.
• For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or to use a highly effective contraceptive method during the treatment period and for at least 4 weeks or 1 menstrual period after the last dose of lebrikizumab.
⁃ Participant must provide signed ICF. Adolescent participants must also provide separate informed assent to enroll in the study and sign and date either a separate IAF or the ICF signed by the parent/legal guardian (as appropriate based on local regulations and requirements).
⁃ Part 2:
⁃ Demonstrate clinical response to treatment at Week 24 of Part 1, defined as achieving EASI 75 or IGA 0/1 without the use of high-potency TCS within the prior 4 weeks or systemic corticosteroids at any time post baseline.