A Study of LY3471851 in Participants With Psoriasis
A Phase 1, Double-Blind, Randomized, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous LY3471851 in Patients With Psoriasis
2 other identifiers
interventional
30
1 country
24
Brief Summary
The main purpose of this study is to learn more about the safety of LY3471851 when given by injection just under the skin to participants with psoriasis. 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 P25-P50 for phase_1
Started Nov 2019
24 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
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 8, 2019
CompletedStudy Start
First participant enrolled
November 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 21, 2021
CompletedFebruary 20, 2024
February 1, 2024
1.7 years
October 7, 2019
February 16, 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 (3)
Placebo
PLACEBO COMPARATORParticipants received placebo administered subcutaneously (SC) every 2 weeks for a period of 12 weeks.
Cohort 1 - 10 (Microgram Per Kilogram) μg/kg LY3471851
EXPERIMENTALParticipants received 10 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks.
Cohort 2 - 24 μg/kg LY3471851
EXPERIMENTALParticipants received 24 μg/kg of LY3471851 SC every 2 weeks for a period of 12 weeks.
Interventions
Eligibility Criteria
You may qualify if:
- Have a confirmed diagnosis of psoriasis for at least 6 months
- Have active psoriasis plaques according to study- specific criteria
- Be willing and able to undergo skin biopsies
You may not qualify if:
- Have received certain topical medications for psoriasis within 14 days prior to baseline
- Have received certain systemic medications for psoriasis 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 (24)
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
Florida Academic Centers Research and Education, LLC
Coral Gables, Florida, 33134, 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
Forefront Research
Louisville, Kentucky, 40241, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Derm Center
Troy, Michigan, 48084, United States
Central Dermatology PC
St Louis, Missouri, 63117, 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, 78229, 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
October 7, 2019
First Posted
October 8, 2019
Study Start
November 26, 2019
Primary Completion
July 21, 2021
Study Completion
July 21, 2021
Last Updated
February 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share