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

NCT03418493 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 16666I9H-MC-FFAA
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

  A summary of SAEs and other non-serious adverse events (AEs), regardless of causality is reported in the Reported Adverse Events module. An SAE is any adverse event from this study that results in 1 of the following: 1. Death 2. Initial or prolonged inpatient hospitalization 3. A life-threatening experience (that is, immediate risk of dying) 4. Persistent or significant disability/incapacity 5. Congenital anomaly/birth defect 6. Important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the subject or may require intervention to prevent 1 of the other outcomes listed in the definition above.

  Pre-dose up to 1 year after administration of study drug

Secondary Outcomes (6)

• Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

  Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose

• Part B: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

  Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85

• Part C: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531

  Pre-dose, Days 1 (End of infusion, 2 hrs after start of infusion, 6 hrs after start of infusion), 2 (24 hrs after start of infusion), 4, 8, 15, 22, 29, 43, 57, 71, 85, and 113 post-dose

• Part A: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞)

  Pre-dose, Days 1 (End of infusion [IV], 2 hrs after start of infusion [IV], 6 hrs after start of infusion [IV] or injection [SC]), 2 (24 hrs after start of infusion [IV] or injection [SC]), 4, 8, 11 (SC only), 15, 22, 29, 43, 57, 71, 85 post- dose

• Part B: PK: Area Under the Concentration Versus Time Curve (AUC) of LY3316531 Over the Dosing Interval (Tau) - AUCtau

  Days 57 (Pre-dose, end of infusion), 58, 60, 64, 67, 71, 78, and 85

Study Arms (5)

LY3316531 (Part A)

EXPERIMENTAL

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).

Drug: LY3316531 - IV; Drug: LY3316531 - SC

Placebo (Part A)

PLACEBO COMPARATOR

Placebo matching LY3316531 administered IV.

Drug: Placebo - IV

LY3316531 (Part B)

EXPERIMENTAL

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

Drug: LY3316531 - IV

Placebo (Part B)

PLACEBO COMPARATOR

Placebo matching LY3316531 administered IV.

Drug: Placebo - IV

LY3316531 (Part C)

EXPERIMENTAL

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

Drug: LY3316531 - IV

Interventions

LY3316531 - IV DRUG

Administered IV.

LY3316531 (Part A); LY3316531 (Part B); LY3316531 (Part C)

LY3316531 - SC DRUG

Administered SC.

LY3316531 (Part A)

Placebo - IV DRUG

Administered IV.

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

Parexel Early Phase Unit at Glendale

Glendale, California, 91206-4140, United States

Location

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Baltimore, Maryland, 21225, United States

Location

Related Links

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

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2018
• First Posted: February 1, 2018
• Study Start: January 30, 2018
• Primary Completion: December 24, 2018
• Study Completion: July 29, 2019
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2022-11-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)