A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis

Study Purpose

The purpose of this study is to evaluate how well LY3316531 is tolerated and what side effects may occur in healthy participants and participants with psoriasis. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). This is a three-part study. Participants will enroll in only one part. Parts A and B are for healthy participants and Part C is for participants with psoriasis. Participation could last between 16 and 57 weeks.

Recruitment Criteria

Accepts Healthy Volunteers

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

Yes
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 - 64 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Healthy Participants - Are overtly healthy males or females, as determined by medical history and physical examination - Females must be of non-childbearing potential - Are between 18 and 64 years of age, inclusive, at screening - Have a body mass index of 18.0 to 32.0 kilograms per meter squared (kg/m²) inclusive - Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures - Psoriasis Participants: - Chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline - Meet psoriasis disease activity criteria - Are at least 18 years of age - Have a minimum body weight of 50 kilograms (kg)

Exclusion Criteria:

- Healthy and Psoriasis Participants - Have known or ongoing neuropsychiatric disorders - Have received live vaccine(s) (included attenuated live vaccines) within 28 days of screening or intend to during the study - Have had any malignancy within the past 5 years except for basal cell or squamous cell epithelial carcinomas of the skin that have been resected with no subsequent evidence of recurrence for at least 3 years prior to screening and cervical carcinoma in situ with no evidence of recurrence within 5 years prior to baseline - Show evidence of active or latent tuberculosis (TB) - Have presence of significant uncontrolled cerebro-cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric disorders or abnormal laboratory values at screening that, in the opinion of the investigator, pose an unacceptable risk to the participant if participating in the study or of interfering with the interpretation of data - Psoriasis Participants Only: - Have received treatment with biologic therapies for psoriasis (such as monoclonal antibodies, including marketed or investigational biologic therapy) - Prior or current use of biologics for indications other than psoriasis may be allowed with sponsor approval - Have received systemic nonbiologic psoriasis therapy within 28 days of baseline - Have received topical psoriasis treatment within 14 days of 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.

NCT03418493
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 United States
Conditions

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

Psoriasis
Study Website: View Trial Website

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.

Parexel Early Phase Unit at Glendale, Glendale, California

Status

Active, not recruiting

Address

Parexel Early Phase Unit at Glendale

Glendale, California, 91206-4140

Site Contact

1-317-615-4559

Baltimore, Maryland

Status

Recruiting

Address

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, 21225

Site Contact

1-317-615-4559

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