Study Stopped
Terminated due to liver findings
A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis
A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
2 other identifiers
interventional
30
2 countries
13
Brief Summary
This study is being conducted to determine how safe and how well tolerated LY3462817 is when given to participants with psoriasis. Blood tests will be done to check how much LY3462817 is in the bloodstream and how long the body takes to get rid of it. The study will last up to one year and one month for each participant. As part of protocol addendum, this study is additionally evaluating the safety and tolerability of LY3509754 in participants with psoriasis. Blood tests will be done to check how much LY3509754 is in the bloodstream and how long the body takes to get rid of it. The addendum will last up to 12 weeks for each participant.
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
Typical duration for phase_1
13 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
November 4, 2019
CompletedFirst Posted
Study publicly available on registry
November 5, 2019
CompletedStudy Start
First participant enrolled
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 9, 2022
CompletedMarch 15, 2022
February 1, 2022
2.2 years
November 4, 2019
February 28, 2022
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 LY3462817 and LY3509754
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 Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Secondary Outcomes (1)
Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Study Arms (6)
LY3462817 - Intravenous (IV)
EXPERIMENTALLY3462817 administered as IV infusions.
Placebo - IV
PLACEBO COMPARATORPlacebo administered as IV infusions.
LY3462817 - Subcutaneous (SC)
EXPERIMENTALLY3462817 administered as SC injections. (SC administration is discretionary/optional.)
Placebo - SC
PLACEBO COMPARATORPlacebo administered as SC injections. (SC administration is discretionary/optional.)
LY3509754
EXPERIMENTALLY3509754 administered orally.
Placebo
PLACEBO COMPARATORPlacebo administered orally.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have been diagnosed with psoriasis for at least 6 months
- Participants must have active psoriasis plaques
- Participants must be willing and able to have skin biopsies (small samples of skin removed for testing)
You may not qualify if:
- Participants must not have received certain medications for psoriasis that are applied to the skin within 14 days prior to baseline (Day 1)
- Participants must not have received certain oral or injectable medications or light therapy for psoriasis within 4 weeks prior to baseline
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Dermatology Associates - Los Angeles
Los Angeles, California, 90045, United States
Miami Dermatology and Laser Research
Miami, Florida, 33173, United States
Advanced Pharma Clinical Research
Miami, Florida, 33175, United States
ForCare Clinical Research
Tampa, Florida, 33613-1244, United States
Avita Clinical Research
Tampa, Florida, 33613, United States
Meridian Clinical Research
Baton Rouge, Louisiana, 70808, United States
DermDox Centers for Dermatology
Hazleton, Pennsylvania, 18201, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Progressive Clinical Research
San Antonio, Texas, 78213, United States
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218, United States
Simcoderm Medical & Surgical Dermatology Centre
Barrie, Ontario, L4M 7G1, Canada
Skin Health
Cobourg, Ontario, K9A 0Z4, Canada
K. Papp Clinical Research
Waterloo, Ontario, N2J 1C4, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
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
November 4, 2019
First Posted
November 5, 2019
Study Start
November 20, 2019
Primary Completion
February 9, 2022
Study Completion
February 9, 2022
Last Updated
March 15, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share