A Study of LY4100511 (DC-853) in Adult Participants With... | NCT06602219

ID	Type	Description	Link
J5C-MC-FOAB	Other Identifier	DCE853201

Status Module

Record Verification Date

Sep 2025

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

Oct 25, 2024Actual

Primary Completion Date

Jul 24, 2025Actual

Completion Date

Sep 4, 2025Actual

First Submitted Date

Sep 16, 2024

First Submission Date that Met QC Criteria

Sep 16, 2024

First Posted Date

Sep 19, 2024Actual

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

Sep 11, 2025

Last Update Posted Date

Sep 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

222Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
LY4100511 Dose 1	Experimental	Participants will receive LY4100511 orally.	Drug: LY4100511
LY4100511 Dose 2	Experimental	Participants will receive LY4100511 orally.	Drug: LY4100511
LY4100511 Dose 3	Experimental	Participants will receive LY4100511 orally.	Drug: LY4100511
Placebo	Placebo Comparator	Placebo administered orally.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
LY4100511	Drug	Administered orally	LY4100511 Dose 1 LY4100511 Dose 2 LY4100511 Dose 3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Psoriasis Area and Severity Index (PASI) 75		Week 12

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving an sPGA Score of 0 (clear) or 1 (almost clear) with ≥2 grade Improvement from Baseline		Week 12
Percentage of Participants Achieving ≥50% Reduction in PASI score (PASI 50)		Week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of plaque psoriasis for 6 months before the baseline day 1 randomization
Must have a body mass index (BMI) of 18 to 40 kilogram/square meter (kg/m2) (inclusive).
Must be willing to discontinue topical and/or systemic therapies for psoriasis before the first dose of study intervention.
Must agree to avoid prolonged exposure to the sun and to refrain from the use of tanning booths, sun lamps, and other sources of ultraviolet light during the study

Exclusion Criteria:

Have had a clinically significant flare of psoriasis during the 12 weeks before the baseline, as assessed by the investigator.
Have a history of erythrodermic psoriasis, generalized or localized pustular psoriasis, predominantly guttate psoriasis, or medication-induced or medication-exacerbated psoriasis.
Have any known or suspected diagnosis of inflammatory conditions other than psoriasis and psoriatic arthritis, including but not limited to rheumatoid arthritis, sarcoidosis, IBD (Crohn's disease or ulcerative colitis), or systemic lupus erythematosus.
Have a diagnosis of psoriatic arthritis requiring, or are currently receiving, systemic immunosuppressant medical treatment (including corticosteroids, immunosuppressants, and biologics).
Have a current or recent acute, active infection. Participant must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment for at least 30 days before screening and up to randomization/baseline.

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
Cahaba Dermatology Skin Health Center		Birmingham	Alabama	35244	United States
Dermatology Trial Associates

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Access Criteria

research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

URL

http://vivli.org/