A Study of LY3361237 in Participants With Psoriasis | NCT04975295

Studies
A Study of LY3361237 in Participants With Psoriasis

NCT04975295

Sponsor

Eli Lilly and Company

Status

Completed

Last Update Posted

Dec 5, 2022Actual

Enrollment

21Actual

Phase

Phase 1

Conditions

Psoriasis

Interventions

LY3361237
Placebo

Countries

Bulgaria
Hungary
Poland
Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
I9S-MC-BTAC	Other Identifier	Eli Lilly and Company
2019-003187-40	EudraCT Number

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2021Actual

Primary Completion Date

Nov 29, 2022Actual

Completion Date

Nov 29, 2022Actual

First Submitted Date

Jul 22, 2021

First Submission Date that Met QC Criteria

Jul 22, 2021

First Posted Date

Jul 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 1, 2022

Last Update Posted Date

Dec 5, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The main purpose of this study is to learn more about the safety and tolerability of LY3361237 and any side effects that might be associated with it when given to participants with psoriasis. LY3361237 will be administered by injections just under the skin. The study will last up to 41 weeks and may include up to 15 visits to the study center.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY3361237	Experimental	LY3361237 administered subcutaneously (SC).	Drug: LY3361237
Placebo	Placebo Comparator	Placebo administered SC.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY3361237	Drug	Administered SC	LY3361237
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 253

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetics (PK): Minimum Serum Concentration (Cmin) of LY3361237 During the Dosing Interval	PK: Cmin of LY3361237 During the Dosing Interval	Day 1 predose through Day 253

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Have chronic plaque psoriasis for at least 6 months
Be willing and able to undergo skin biopsies
Body mass index (BMI) within the range of 18 to 40 kilograms per meter squared (kg/m²)
Female participants must agree to use birth control during the study

Exclusion Criteria:

Have had certain types of infection within the last six months
Have a clinically significant active infection, or recent acute active infection within the last 30 days
Have other serious or unstable illnesses
Have a history of organ or bone marrow transplant
Have received any live vaccine within the last 4 weeks prior to screening
Have received systemic nonbiologic psoriasis therapy within 4 weeks prior to study day 1
Have received topical psoriasis treatment within 14 days prior to study day 1
Have excessive skin exposure or use tanning booths for at least 4 weeks prior to study day 1

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MC Comac Medical		Sofia		1606	Bulgaria
Budai Irgalmasrendi Korhaz

Label	URL
A Study of LY3361237 in Participants With Psoriasis	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D011565	Psoriasis

Ancestor Terms

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

Browse Leaves

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Browse Branches

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