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

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.

Study Overview

• Status: Terminated
• Conditions: Psoriasis
• Intervention / Treatment: Drug: Placebo - SC; Drug: Placebo - IV; Drug: Placebo; Drug: LY3462817 - IV; Drug: LY3462817 - SC; Drug: LY3509754

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Simcoderm Medical & Surgical Dermatology Centre
    • Cobourg, Ontario, Canada, K9A 0Z4
      • Skin Health
    • Waterloo, Ontario, Canada, N2J 1C4
      • K. Papp Clinical Research
• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Associates - Los Angeles
  • Florida
    • Miami, Florida, United States, 33173
      • Miami Dermatology and Laser Research
    • Miami, Florida, United States, 33175
      • Advanced Pharma Clinical Research
    • Tampa, Florida, United States, 33613-1244
      • Forcare Clinical Research
    • Tampa, Florida, United States, 33613
      • Avita Clinical Research
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Meridian Clinical Research
  • Pennsylvania
    • Hazleton, Pennsylvania, United States, 18201
      • DermDox Centers for Dermatology
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • Texas
    • San Antonio, Texas, United States, 78218
      • Texas Dermatology and Laser Specialists
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo administered orally.	Drug: Placebo; Administered orally.
Experimental: LY3462817 - Intravenous (IV); LY3462817 administered as IV infusions.	Drug: LY3462817 - IV; Administered IV
Placebo Comparator: Placebo - IV; Placebo administered as IV infusions.	Drug: Placebo - IV; Administered IV
Experimental: LY3462817 - Subcutaneous (SC); LY3462817 administered as SC injections. (SC administration is discretionary/optional.)	Drug: LY3462817 - SC; Administered SC
Placebo Comparator: Placebo - SC; Placebo administered as SC injections. (SC administration is discretionary/optional.)	Drug: Placebo - SC; Administered SC
Experimental: LY3509754; LY3509754 administered orally.	Drug: LY3509754; Administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Average Concentration (Cave) of LY3462817 and LY3509754	PK: Cave of LY3462817 and LY3509754	Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for LY3509754)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

• A Safety Study of LY3462817 in Participants With Psoriasis

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2019
• Primary Completion (Actual): February 9, 2022
• Study Completion (Actual): February 9, 2022

Study Registration Dates

• First Submitted: November 4, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 17218; J1A-MC-KDAC (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No