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NCT04152382 Clinical Trial

A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Psoriasis Clinical Trial

Official title:
A Multiple-Dose, Randomized, Placebo-Controlled, Study of LY3462817 or LY3509754 in Patients With Psoriasis

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT04152382
Other study ID # 17218
Secondary ID J1A-MC-KDAC
Status Terminated
Phase Phase 1
First received
Last updated
Start date November 20, 2019
Est. completion date February 9, 2022

Study information
Verified date February 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 30
Est. completion date February 9, 2022
Est. primary completion date February 9, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• LY3462817 - IV
Administered IV
• LY3462817 - SC
Administered SC
• Placebo - IV
Administered IV
• Placebo - SC
Administered SC
• LY3509754
Administered orally.
• Placebo
Administered orally.

Locations
Country Name City State
Canada Simcoderm Medical & Surgical Dermatology Centre Barrie Ontario
Canada Skin Health Cobourg Ontario
Canada K. Papp Clinical Research Waterloo Ontario
United States Meridian Clinical Research Baton Rouge Louisiana
United States DermDox Centers for Dermatology Hazleton Pennsylvania
United States Dermatology Associates - Los Angeles Los Angeles California
United States Advanced Pharma Clinical Research Miami Florida
United States Miami Dermatology and Laser Research Miami Florida
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States Progressive Clinical Research San Antonio Texas
United States Texas Dermatology and Laser Specialists San Antonio Texas
United States Avita Clinical Research Tampa Florida
United States ForCare Clinical Research Tampa Florida

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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)
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Completed NCT04894890 - A Prospective Multicenter Study for the Assessment of Treatment Patterns, Effectiveness and Safety of Secukinumab in Adult Patients With Moderate to Severe Plaque Psoriasis in a Real-world Setting in China
Completed NCT00358384 - Chronic Plaque Psoriasis Study With Topical Formulation Of GW786034 Phase 1
Completed NCT03757013 - A Study to Assess Benefits of Apremilast in Patients With Moderate to Severe Chronic Plaque Psoriasis Followed by Dermatologists Under Real Life Settings in France
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
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