A Study of LY3316531 in Healthy Participants and in Parti... | NCT03418493

NCT03418493

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
I9H-MC-FFAA	Other Identifier	Eli Lilly and Company

Status Module

Description Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
LY3316531 - IV	Drug	Administered IV.	LY3316531 (Part A) LY3316531 (Part B) LY3316531 (Part C)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Pre-dose up to 1 year after administration of study drug

Secondary Outcomes

Measure	Description	Time Frame
Part A: Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3316531	PK: Cmax of LY3316531. Under time frame, hours was abbreviated as "hrs."	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

Eligibility Module

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

Name	Affiliation	Role
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

Facility	Status	City	State	ZIP	Country	Contacts
Parexel Early Phase Unit at Glendale		Glendale	California	91206-4140	United States
PAREXEL-Phase 1 Baltimore Harbor Hospital Center

Label	URL
A Study of LY3316531 in Healthy Participants and in Participants With Psoriasis	View source

Arm/Group Information

ID	Title	Description
FG000	Placebo - Part A	Participants received single IV doses of Placebo.
FG001	3 mg LY3316531 IV - Part A	Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).
FG002	15 mg LY3316531 IV - Part A	Participants received single doses of 15 mg LY3316531 administered IV.
FG003	75 mg LY3316531 IV - Part A	Participants received single doses of 75 mg LY3316531 administered IV.
FG004	300 mg LY3316531 IV - Part A	Participants received single doses of 300 mg LY3316531 administered IV.
FG005	300 mg LY3316531 SC- Part A	Participants received single doses of 300 mg LY3316531 administered Subcutaneously (SC).
FG006	900 mg LY3316531 IV - Part A	Participants received single doses of 900 mg LY3316531 administered IV.
FG007	2000 mg LY3316531 IV - Part A	Participants received single doses of 2000 mg LY3316531 administered IV.
FG008	Placebo - Part B	Participants received 3 doses of Placebo administered IV (1 dose every 4 weeks).
FG009	2000 mg LY3316531 IV - Part B	Participants received 3 doses of 2000 mg LY3316531 administered IV (1 dose every 4 weeks).
FG010	300 mg LY3316531 IV - Part C	Participants with psoriasis received single doses of 300 mg LY3316531 administered IV.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Placebo - Part A	Participants received single IV doses of Placebo.
BG001	3 mg LY3316531 IV - Part A	Participants received single doses of 3 milligrams (mg) LY3316531 administered Intravenously (IV).

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

All randomized participants who received study drug.

Posted

Count of Participants

Participants

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

ID	Title	Description
OG000	Placebo - Part A

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo - Part A	Participants received single IV doses of Placebo.	0

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Aug 17, 2018	Jun 3, 2020	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Jan 31, 2018	Jun 3, 2020	SAP_001.pdf

ID	Term
D017444	Skin Diseases, Papulosquamous
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases