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

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3316531 - IV

LY3316531 - SC

Placebo - IV

About this trial

This is an interventional basic science trial for Psoriasis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesAccepts 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

Sites / Locations

Parexel Early Phase Unit at Glendale
PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Arm Label

LY3316531 (Part A)

Placebo (Part A)

LY3316531 (Part B)

Placebo (Part B)

LY3316531 (Part C)

Arm 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).

Placebo matching LY3316531 administered IV.

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

Placebo matching LY3316531 administered IV.

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

Outcomes

Primary Outcome Measures

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: Death Initial or prolonged inpatient hospitalization A life-threatening experience (that is, immediate risk of dying) Persistent or significant disability/incapacity Congenital anomaly/birth defect 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.

Secondary Outcome Measures

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

PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."

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

PK: Cmax of LY3316531 following the Day 57 dose.

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

PK: Cmax of LY3316531.

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

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

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

AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.

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

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

Full Information

NCT ID

NCT03418493

First Posted

January 26, 2018

Last Updated

November 11, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT03418493

Brief Title

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

Official Title

A Phase 1 Randomized, Placebo-Controlled Study of LY3316531 in Healthy Subjects and an Open-Label, Single-Dose Study in Patients With Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

November 1, 2022

Overall Recruitment Status

Completed

Study Start Date

January 30, 2018 (Actual)

Primary Completion Date

December 24, 2018 (Actual)

Study Completion Date

July 29, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

63 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3316531 (Part A)

Arm Type

Experimental

Arm 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).

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo matching LY3316531 administered IV.

Arm Title

LY3316531 (Part B)

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo matching LY3316531 administered IV.

Arm Title

LY3316531 (Part C)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LY3316531 - IV

Intervention Description

Administered IV.

Intervention Type

Drug

Intervention Name(s)

LY3316531 - SC

Intervention Description

Administered SC.

Intervention Type

Drug

Intervention Name(s)

Placebo - IV

Intervention Description

Administered IV.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."

Time Frame

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

Title

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

Description

PK: Cmax of LY3316531 following the Day 57 dose.

Time Frame

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

Title

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

Description

PK: Cmax of LY3316531.

Time Frame

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

Title

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

Description

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

Time Frame

Title

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

Description

AUC of LY3316531 over the dosing interval (tau = 672 h = 28 days) following the Day 57 dose.

Time Frame

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

Title

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

Description

Area Under the Concentration Versus Time Curve (AUC) of LY3316531 From Time Zero to Infinity - AUC(0-∞).

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

64 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Parexel Early Phase Unit at Glendale

City

Glendale

State/Province

California

ZIP/Postal Code

91206-4140

Country

United States

Facility Name

PAREXEL-Phase 1 Baltimore Harbor Hospital Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21225

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

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

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