A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Atopic Dermatitis
Who is this study for? Patients with Atopic Dermatitis
What treatments are being studied? NKTR-358
Status: Completed
Location: See all (20) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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
Locations
United States
Arkansas
Arkansas Research Trials, LLC
North Little Rock
California
California Dermatology & Clinical Research Institute
Encinitas
Center For Dermatology Clinical Research, Inc.
Fremont
Therapeutics Clinical Research
San Diego
Clinical Science Institute
Santa Monica
Florida
Miami Dermatology and Laser Research
Miami
ForCare Clinical Research
Tampa
Georgia
Medical Dermatology Specialists
Sandy Springs
Indiana
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Kentucky
Skin Sciences
Louisville
Michigan
Derm Center
Troy
New Hampshire
ActivMed Practices and Research
Portsmouth
Ohio
Remington-Davis, Inc
Columbus
Oklahoma
Unity Clinical Research
Oklahoma City
Pennsylvania
Paddington Testing Company Inc
Philadelphia
DermDox Centers for Dermatology
Sugarloaf
Texas
Studies in Dermatology, LLC
Cypress
Rodgers Dermatology
Frisco
Progressive Clinical Research
San Antonio
Complete Dermatology
Sugar Land
Time Frame
Start Date: 2019-12-04
Completion Date: 2022-06-24
Participants
Target number of participants: 48
Treatments
Active_comparator: 10 µg/kg LY3471851
Participants received subcutaneous (SC) injection of 10 microgram per kilogram (μg/kg) LY3471851 every 2 weeks for a treatment period of 12 weeks.
Active_comparator: 12 µg/kg LY3471851
Participants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
Active_comparator: 24 µg/kg LY3471851
Participants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
Placebo_comparator: Placebo
Participants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.
Authors
Cindy E Owen, Sunil Dhawan, Jill S Waibel, Timothy G Rodgers, Kimberly Kleveland Grande, Craig L Leonardi, Leon H Kircik, George J Murakawa, Scott Dinehart, Scott A Fretzin, Paul Steven Yamauchi, Michelle C Chambers, Stephen M Schleicher, Mark S Lee, Ryan Harris, Jamie Debra Weisman, Vivian Laquer, Natalia Filipof, Francisco A Kerdel, Lawrence C. Parish, Seth B Forman, Lauren Campbell, Bartley J Gill, Neal D Bhatia, Jarad Levin
Related Therapeutic Areas
Sponsors
Collaborators: Eli Lilly and Company
Leads: Nektar Therapeutics