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A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Primary Purpose

Psoriasis

Status
Terminated
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3462817 - IV
LY3462817 - SC
Placebo - IV
Placebo - SC
LY3509754
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Psoriasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Sites / Locations

  • Dermatology Associates - Los Angeles
  • Miami Dermatology and Laser Research
  • Advanced Pharma Clinical Research
  • ForCare Clinical Research
  • Avita Clinical Research
  • Meridian Clinical Research
  • DermDox Centers for Dermatology
  • University of Pittsburgh Medical Center
  • Progressive Clinical Research
  • Texas Dermatology and Laser Specialists
  • Simcoderm Medical & Surgical Dermatology Centre
  • Skin Health
  • K. Papp Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

LY3462817 - Intravenous (IV)

Placebo - IV

LY3462817 - Subcutaneous (SC)

Placebo - SC

LY3509754

Placebo

Arm Description

LY3462817 administered as IV infusions.

Placebo administered as IV infusions.

LY3462817 administered as SC injections. (SC administration is discretionary/optional.)

Placebo administered as SC injections. (SC administration is discretionary/optional.)

LY3509754 administered orally.

Placebo administered orally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
PK: Cave of LY3462817 and LY3509754

Full Information

First Posted
November 4, 2019
Last Updated
February 28, 2022
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04152382
Brief Title
A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis
Official Title
A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to liver findings
Study Start Date
November 20, 2019 (Actual)
Primary Completion Date
February 9, 2022 (Actual)
Study Completion Date
February 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3462817 - Intravenous (IV)
Arm Type
Experimental
Arm Description
LY3462817 administered as IV infusions.
Arm Title
Placebo - IV
Arm Type
Placebo Comparator
Arm Description
Placebo administered as IV infusions.
Arm Title
LY3462817 - Subcutaneous (SC)
Arm Type
Experimental
Arm Description
LY3462817 administered as SC injections. (SC administration is discretionary/optional.)
Arm Title
Placebo - SC
Arm Type
Placebo Comparator
Arm Description
Placebo administered as SC injections. (SC administration is discretionary/optional.)
Arm Title
LY3509754
Arm Type
Experimental
Arm Description
LY3509754 administered orally.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered orally.
Intervention Type
Drug
Intervention Name(s)
LY3462817 - IV
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
LY3462817 - SC
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo - IV
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo - SC
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
LY3509754
Intervention Description
Administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered orally.
Primary Outcome Measure Information:
Title
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754
Description
A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Time Frame
Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)
Secondary Outcome Measure Information:
Title
Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754
Description
PK: Cave of LY3462817 and LY3509754
Time Frame
Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Dermatology Associates - Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90045
Country
United States
Facility Name
Miami Dermatology and Laser Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Advanced Pharma Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
ForCare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613-1244
Country
United States
Facility Name
Avita Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Meridian Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
DermDox Centers for Dermatology
City
Hazleton
State/Province
Pennsylvania
ZIP/Postal Code
18201
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Texas Dermatology and Laser Specialists
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78218
Country
United States
Facility Name
Simcoderm Medical & Surgical Dermatology Centre
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 7G1
Country
Canada
Facility Name
Skin Health
City
Cobourg
State/Province
Ontario
ZIP/Postal Code
K9A 0Z4
Country
Canada
Facility Name
K. Papp Clinical Research
City
Waterloo
State/Province
Ontario
ZIP/Postal Code
N2J 1C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/azmsPbmvZOOmiS1aMi7nO
Description
A Safety Study of LY3462817 in Participants With Psoriasis

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A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

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