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A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

NCT ID: NCT04152382

Last Updated: 2022-03-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-20

Study Completion Date

2022-02-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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LY3462817 - Intravenous (IV)

LY3462817 administered as IV infusions.

Group Type EXPERIMENTAL

LY3462817 - IV

Intervention Type DRUG

Administered IV

Placebo - IV

Placebo administered as IV infusions.

Group Type PLACEBO_COMPARATOR

Placebo - IV

Intervention Type DRUG

Administered IV

LY3462817 - Subcutaneous (SC)

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

Group Type EXPERIMENTAL

LY3462817 - SC

Intervention Type DRUG

Administered SC

Placebo - SC

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

Group Type PLACEBO_COMPARATOR

Placebo - SC

Intervention Type DRUG

Administered SC

LY3509754

LY3509754 administered orally.

Group Type EXPERIMENTAL

LY3509754

Intervention Type DRUG

Administered orally.

Placebo

Placebo administered orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally.

Interventions

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LY3462817 - IV

Administered IV

Intervention Type DRUG

LY3462817 - SC

Administered SC

Intervention Type DRUG

Placebo - IV

Administered IV

Intervention Type DRUG

Placebo - SC

Administered SC

Intervention Type DRUG

LY3509754

Administered orally.

Intervention Type DRUG

Placebo

Administered orally.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Dermatology Associates - Los Angeles

Los Angeles, California, United States

Site Status

Miami Dermatology and Laser Research

Miami, Florida, United States

Site Status

Advanced Pharma Clinical Research

Miami, Florida, United States

Site Status

ForCare Clinical Research

Tampa, Florida, United States

Site Status

Avita Clinical Research

Tampa, Florida, United States

Site Status

Meridian Clinical Research

Baton Rouge, Louisiana, United States

Site Status

DermDox Centers for Dermatology

Hazleton, Pennsylvania, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Progressive Clinical Research

San Antonio, Texas, United States

Site Status

Texas Dermatology and Laser Specialists

San Antonio, Texas, United States

Site Status

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, Canada

Site Status

Skin Health

Cobourg, Ontario, Canada

Site Status

K. Papp Clinical Research

Waterloo, Ontario, Canada

Site Status

Countries

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United States Canada

Related Links

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https://trials.lillytrialguide.com/en-US/trial/azmsPbmvZOOmiS1aMi7nO

A Safety Study of LY3462817 in Participants With Psoriasis

Other Identifiers

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J1A-MC-KDAC

Identifier Type: OTHER

Identifier Source: secondary_id

17218

Identifier Type: -

Identifier Source: org_study_id

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