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

NCT ID: NCT03418493

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-30
• Study Completion Date: 2019-07-29

Brief 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.

Conditions

Psoriasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3316531 (Part A)

Participants received single doses of 3 milligrams (mg), 15 mg, 75 mg, 300 mg, 900 mg, or 2000 mg LY3316531 administered Intravenously (IV), or 300 mg LY3316531 administered Subcutaneously (SC).

Group Type: EXPERIMENTAL

LY3316531 - IV

Intervention Type: DRUG

Administered IV.

LY3316531 - SC

Intervention Type: DRUG

Administered SC.

Placebo (Part A)

Placebo matching LY3316531 administered IV.

Group Type: PLACEBO_COMPARATOR

Placebo - IV

Intervention Type: DRUG

Administered IV.

LY3316531 (Part B)

Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).

Group Type: EXPERIMENTAL

LY3316531 - IV

Intervention Type: DRUG

Administered IV.

Placebo (Part B)

Placebo matching LY3316531 administered IV.

Group Type: PLACEBO_COMPARATOR

Placebo - IV

Intervention Type: DRUG

Administered IV.

LY3316531 (Part C)

Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.

Group Type: EXPERIMENTAL

LY3316531 - IV

Intervention Type: DRUG

Administered IV.

Interventions

LY3316531 - IV

Administered IV.

Intervention Type: DRUG

LY3316531 - SC

Administered SC.

Intervention Type: DRUG

Placebo - IV

Administered IV.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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

Parexel Early Phase Unit at Glendale

Glendale, California, United States

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://www.lillytrialguide.com/en-US/studies/psoriasis/FFAA#?postal=

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

Other Identifiers

I9H-MC-FFAA

Identifier Type: OTHER

Identifier Source: secondary_id

16666

Identifier Type: -

Identifier Source: org_study_id