A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden
Eli Lilly and Company
Summary
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.
Eligibility
- Age range
- 12+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit. * Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline. * Have pruritus numeric rating scale (NRS) ≥6 at baseline. * Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline. * Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline. * Based on investigator judgement, have a history of inadequate response to tr…
Interventions
- DrugLebrikizumab
Administered SC
Locations (66)
- Total Skin & Beauty Dermatology Center, PC DBA Total DermatologyBirmingham, Alabama
- Research Solutions of ArizonaLitchfield Park, Arizona
- Alliance Dermatology and Mohs CenterPhoenix, Arizona
- California Dermatology & Clinical Research InstituteEncinitas, California
- Dermatology Research AssociatesLos Angeles, California
- NorCal Clinical ResearchRocklin, California