Psoriasis Clinical Trial

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

Summary

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

63

Study ID:

NCT03418493

Recruitment Status:

Completed

Sponsor:

Eli Lilly and Company

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There are 2 Locations for this study

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Parexel Early Phase Unit at Glendale
Glendale California, 91206, United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center
Baltimore Maryland, 21225, United States

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 1

Estimated Enrollment:

63

Study ID:

NCT03418493

Recruitment Status:

Completed

Sponsor:


Eli Lilly and Company

How clear is this clinincal trial information?

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