A Study of LY3471851 in Participants With Eczema
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
2 other identifiers
interventional
48
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Dec 2019
Typical duration for phase_1
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 5, 2019
CompletedFirst Posted
Study publicly available on registry
September 9, 2019
CompletedStudy Start
First participant enrolled
December 4, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 24, 2022
CompletedFebruary 20, 2024
February 15, 2024
2.6 years
September 5, 2019
February 15, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Baseline through Study Completion (up to Week 48)
Secondary Outcomes (3)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3471851
Postdose on Day 1 through Day 14
PK: Trough Concentrations (Ctrough) of LY3471851
Week 12
PK: Maximum Concentration (Cmax) of LY3471851
Postdose on Day 1 through Day 14
Study Arms (4)
10 µg/kg LY3471851
ACTIVE COMPARATORParticipants 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
ACTIVE COMPARATORParticipants received subcutaneous injection of 12 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
24 µg/kg LY3471851
ACTIVE COMPARATORParticipants received subcutaneous injection of 24 μg/kg LY3471851 every 2 weeks for a treatment period of 12 weeks.
Placebo
PLACEBO COMPARATORParticipants received subcutaneous injection of placebo every 2 weeks for a treatment period of 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nektar Therapeuticslead
- Eli Lilly and Companycollaborator
Study Sites (20)
Arkansas Research Trials, LLC
North Little Rock, Arkansas, 72117, United States
California Dermatology & Clinical Research Institute
Encinitas, California, 92024, United States
Center For Dermatology Clinical Research, Inc.
Fremont, California, 94538, United States
Therapeutics Clinical Research
San Diego, California, 92123, United States
Clinical Science Institute
Santa Monica, California, 90404, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Medical Dermatology Specialists
Sandy Springs, Georgia, 30328, United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis, Indiana, 46250, United States
Skin Sciences
Louisville, Kentucky, 40217, United States
Derm Center
Troy, Michigan, 48084, United States
ActivMed Practices and Research
Portsmouth, New Hampshire, 03801, United States
Remington-Davis, Inc
Columbus, Ohio, 43215, United States
Unity Clinical Research
Oklahoma City, Oklahoma, 73118, United States
Paddington Testing Company Inc
Philadelphia, Pennsylvania, 19103, United States
DermDox Centers for Dermatology
Sugarloaf, Pennsylvania, 18249, United States
Studies in Dermatology, LLC
Cypress, Texas, 77433, United States
Rodgers Dermatology
Frisco, Texas, 75034, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Complete Dermatology
Sugar Land, Texas, 77478, United States
Related Publications (1)
Silverberg JI, Rosmarin D, Chovatiya R, Bieber T, Schleicher S, Beck L, Gooderham M, Chaudhry S, Fanton C, Yu D, Levy J, Liu Y, Miyazaki T, Tagliaferri M, Schmitz C, Nirula A, Kotzin B, Zalevsky J. The regulatory T cell-selective interleukin-2 receptor agonist rezpegaldesleukin in the treatment of inflammatory skin diseases: two randomized, double-blind, placebo-controlled phase 1b trials. Nat Commun. 2024 Oct 25;15(1):9230. doi: 10.1038/s41467-024-53384-1.
PMID: 39455575DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Nektar Therapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 5, 2019
First Posted
September 9, 2019
Study Start
December 4, 2019
Primary Completion
June 24, 2022
Study Completion
June 24, 2022
Last Updated
February 20, 2024
Record last verified: 2024-02-15
Data Sharing
- IPD Sharing
- Will not share