A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Phase 1

Terminated

• Conditions: Psoriasis
• Interventions: Drug: LY3462817 - IV; Drug: Placebo - IV; Drug: LY3462817 - SC; Drug: Placebo - SC; Drug: LY3509754; Drug: Placebo

• Registration Number: NCT04152382
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-11-04
• Study First Submitted QC: 2019-11-04
• Study First Posted: 2019-11-05
• Study Start: 2019-11-20
• Status Verified: 2022-02
• Primary Completion: 2022-02-09
• Study Completion: 2022-02-09
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 30

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3462817 - Intravenous (IV)	LY3462817 - IV	LY3462817 administered as IV infusions.
Placebo - IV	Placebo - IV	Placebo administered as IV infusions.
LY3462817 - Subcutaneous (SC)	LY3462817 - SC	LY3462817 administered as SC injections. (SC administration is discretionary/optional.)
Placebo - SC	Placebo - SC	Placebo administered as SC injections. (SC administration is discretionary/optional.)
LY3509754	LY3509754	LY3509754 administered orally.
Placebo	Placebo	Placebo administered orally.

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to LY3462817 and LY3509754	Baseline through Final Follow-up (up to Week 52 for LY3462817 & up to Week 16 for 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

Name	Time	Method
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)	PK: Cave of LY3462817 and LY3509754

Trial Locations

Locations (13)

K. Papp Clinical Research; 🇨🇦 Waterloo, Ontario, Canada

Progressive Clinical Research; 🇺🇸 San Antonio, Texas, United States

Meridian Clinical Research; 🇺🇸 Baton Rouge, Louisiana, United States

Texas Dermatology and Laser Specialists; 🇺🇸 San Antonio, Texas, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Advanced Pharma Clinical Research; 🇺🇸 Miami, Florida, United States

Avita Clinical Research; 🇺🇸 Tampa, Florida, United States

Dermatology Associates - Los Angeles; 🇺🇸 Los Angeles, California, United States

Miami Dermatology and Laser Research; 🇺🇸 Miami, Florida, United States

ForCare Clinical Research; 🇺🇸 Tampa, Florida, United States

Simcoderm Medical & Surgical Dermatology Centre; 🇨🇦 Barrie, Ontario, Canada

Skin Health; 🇨🇦 Cobourg, Ontario, Canada

DermDox Centers for Dermatology; 🇺🇸 Hazleton, Pennsylvania, United States