A Safety Study of LY3462817 and LY3509754 in Participants With Psoriasis

Study Purpose

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 Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04152382
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Eli Lilly and Company
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

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)
Principal Investigator Affiliation Eli Lilly and Company
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Study Website: View Trial Website
Arms & Interventions

Arms

Experimental: LY3462817 - Intravenous (IV)

LY3462817 administered as IV infusions.

Placebo Comparator: Placebo - IV

Placebo administered as IV infusions.

Experimental: LY3462817 - Subcutaneous (SC)

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

Placebo Comparator: Placebo - SC

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

Experimental: LY3509754

LY3509754 administered orally.

Placebo Comparator: Placebo

Placebo administered orally.

Interventions

Drug: - LY3462817 - IV

Administered IV

Drug: - LY3462817 - SC

Administered SC

Drug: - Placebo - IV

Administered IV

Drug: - Placebo - SC

Administered SC

Drug: - LY3509754

Administered orally.

Drug: - Placebo

Administered orally.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dermatology Associates - Los Angeles, Los Angeles, California

Status

Recruiting

Address

Dermatology Associates - Los Angeles

Los Angeles, California, 90045

Miami Dermatology and Laser Research, Miami, Florida

Status

Recruiting

Address

Miami Dermatology and Laser Research

Miami, Florida, 33173

Advanced Pharma Clinical Research, Miami, Florida

Status

Recruiting

Address

Advanced Pharma Clinical Research

Miami, Florida, 33175

ForCare Clinical Research, Tampa, Florida

Status

Recruiting

Address

ForCare Clinical Research

Tampa, Florida, 33613-1244

Avita Clinical Research, Tampa, Florida

Status

Completed

Address

Avita Clinical Research

Tampa, Florida, 33613

Meridian Clinical Research, Baton Rouge, Louisiana

Status

Recruiting

Address

Meridian Clinical Research

Baton Rouge, Louisiana, 70808

DermDox Centers for Dermatology, Hazleton, Pennsylvania

Status

Recruiting

Address

DermDox Centers for Dermatology

Hazleton, Pennsylvania, 18201

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213

Progressive Clinical Research, San Antonio, Texas

Status

Recruiting

Address

Progressive Clinical Research

San Antonio, Texas, 78213

Texas Dermatology and Laser Specialists, San Antonio, Texas

Status

Recruiting

Address

Texas Dermatology and Laser Specialists

San Antonio, Texas, 78218

International Sites

Barrie, Ontario, Canada

Status

Completed

Address

Simcoderm Medical & Surgical Dermatology Centre

Barrie, Ontario, L4M 7G1

Skin Health, Cobourg, Ontario, Canada

Status

Completed

Address

Skin Health

Cobourg, Ontario, K9A 0Z4

K. Papp Clinical Research, Waterloo, Ontario, Canada

Status

Completed

Address

K. Papp Clinical Research

Waterloo, Ontario, N2J 1C4

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