A Study of LY3471851 in Participants With Eczema
- Registration Number
- NCT04081350
- Lead Sponsor
- Nektar Therapeutics
- Brief Summary
The main purpose of this study is to learn more about the safety and side effects of LY3471851 when given by injection just under the skin to participants with eczema. The study will last up to 48 weeks and may include up to 23 visits to the study center.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
- Have a confirmed diagnosis of atopic dermatitis (AD) for least 12 months
- Have active AD according to study specific criteria
- Be willing and able to undergo skin biopsies
- Have received certain topical medications for AD within 14 days prior to baseline
- Have received certain systemic medications for AD within 4 weeks prior to baseline
- Have received LY3471851 previously
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks. 10 µg/kg LY3471851 LY3471851 Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks. 12 µg/kg LY3471851 LY3471851 Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks. 24 µg/kg LY3471851 LY3471851 Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
- Primary Outcome Measures
Name Time Method Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Baseline through Study Completion (up to Week 48) A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method PK: Trough Concentrations (Ctrough) of LY3471851 Week 12 PK: Ctrough of LY3471851
PK: Maximum Concentration (Cmax) of LY3471851 Postdose on Day 1 through Day 14 PK: Cmax of LY3471851
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851 Postdose on Day 1 through Day 14 PK: AUC of LY3471851
Trial Locations
- Locations (20)
Complete Dermatology
🇺🇸Sugar Land, Texas, United States
Clinical Science Institute
🇺🇸Santa Monica, California, United States
Remington-Davis, Inc
🇺🇸Columbus, Ohio, United States
Paddington Testing Company Inc
🇺🇸Philadelphia, Pennsylvania, United States
DermDox Centers for Dermatology
🇺🇸Sugarloaf, Pennsylvania, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Derm Center
🇺🇸Troy, Michigan, United States
Miami Dermatology and Laser Research
🇺🇸Miami, Florida, United States
Progressive Clinical Research
🇺🇸San Antonio, Texas, United States
Therapeutics Clinical Research
🇺🇸San Diego, California, United States
Arkansas Research Trials, LLC
🇺🇸North Little Rock, Arkansas, United States
California Dermatology & Clinical Research Institute
🇺🇸Encinitas, California, United States
Center For Dermatology Clinical Research, Inc.
🇺🇸Fremont, California, United States
Medical Dermatology Specialists
🇺🇸Sandy Springs, Georgia, United States
Dawes Fretzin Clinical Research Group, LLC
🇺🇸Indianapolis, Indiana, United States
Skin Sciences
🇺🇸Louisville, Kentucky, United States
ActivMed Practices and Research
🇺🇸Portsmouth, New Hampshire, United States
Unity Clinical Research
🇺🇸Oklahoma City, Oklahoma, United States
Rodgers Dermatology
🇺🇸Frisco, Texas, United States
Studies in Dermatology, LLC
🇺🇸Cypress, Texas, United States