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

Lilly

Status and phase: Completed; Phase 1

Conditions: Psoriasis

Treatments: Drug: LY3316531 - IV; Drug: LY3316531 - SC; Drug: Placebo - IV

Study type: Interventional

Funder types: Industry

Identifiers

NCT03418493

I9H-MC-FFAA (Other Identifier)

16666

Details and patient eligibility

About

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.

Enrollment: 63 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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63 participants in 5 patient groups, including a placebo group

LY3316531 (Part A)

Experimental group

Description:

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).

Treatment:

Drug: LY3316531 - IV

Drug: LY3316531 - SC

Placebo (Part A)

Placebo Comparator group

Description:

Placebo matching LY3316531 administered IV.

Treatment:

Drug: Placebo - IV

LY3316531 (Part B)

Experimental group

Description:

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

Treatment:

Drug: LY3316531 - IV

Placebo (Part B)

Placebo Comparator group

Description:

Placebo matching LY3316531 administered IV.

Treatment:

Drug: Placebo - IV

LY3316531 (Part C)

Experimental group

Description:

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

Treatment:

Drug: LY3316531 - IV