A Study of LY3972406 in Adult Participants With Moderate-to-Severe Plaque Psoriasis

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3972406 in Adults With Moderate-to-Severe Plaque Psoriasis

The main purpose of this study is to determine the efficacy and safety of LY3972406 in adult participants with moderate-to-severe plaque psoriasis.

Study Overview

• Status: Completed
• Conditions: Plaque Psoriasis
• Intervention / Treatment: Drug: Placebo; Drug: LY3972406

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90045
      • Dermatology Research Associates
    • Santa Monica, California, United States, 90404
      • Clinical Science Institute
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Driven Research
    • Winter Park, Florida, United States, 32789
      • Conquest Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Schweiger Dermatology Group
    • Kenilworth, New Jersey, United States, 07033
      • Metropolitan Dermatology - Clark
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Accellacare - Winston-Salem
  • Ohio
    • Columbus, Ohio, United States, 43215
      • Remington-Davis, Inc
  • Pennsylvania
    • Camp Hill, Pennsylvania, United States, 17011
      • DermDox Centers for Dermatology
  • Texas
    • Houston, Texas, United States, 77004
      • Center for Clinical Studies
    • Houston, Texas, United States, 77056
      • Austin Institute for Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have moderate-to-severe chronic plaque psoriasis for at least 6 months prior to baseline
• Have venous access sufficient to allow for blood sampling
• Are able to swallow oral medication

Exclusion Criteria:

• Have any other skin conditions, excluding plaque psoriasis
• Have a current or recent acute, active infection
• Have manifestations of other autoimmune diseases, such as systemic lupus erythematosus.
• Are lactating or breastfeeding women

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LY3972406; Participants received an oral dose of LY3972406 for 12 weeks.	Drug: LY3972406; Administered orally
Placebo Comparator: Placebo; Participants received an oral dose of placebo for 12 weeks.	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)	The PASI is an investigator-administered, multi-item scale used to measure the severity of psoriasis based on lesion severity and the percent of body surface area (BSA) affected.; Erythema, thickness, and scaling are scored on a scale of 0 (none) to 4 (very severe) on 4 anatomical regions: head, trunk, upper limbs, lower limbs. Degree of involvement on each of the 4 anatomic regions is scored on a scale of 0 (no involvement) to 6 (90% to 100% involvement).; The sum of severity scores for erythema, thickness, and scaling is multiplied by the degree of involvement for each anatomic region, and then multiplied by a constant corresponding to the region's percent BSA (0.1, 0.3, 0.2, and 0.4 for the above 4 regions, respectively). The resultant score for each anatomic region is then summed to yield the final PASI score. It ranges from 0 to 72, with higher scores reflecting greater disease severity.; The nonresponder imputation (NRI) method was used to handle missing data.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Percent Body Surface Area (BSA)	The percent BSA is the total percentage of psoriasis involvement on the participant's body surface, ranging from 0% (no involvement) to 100% (full involvement). It is measured using the handprint method, where 1% corresponds to the size of the participant's hand (including the palm, fingers, and thumb). The number of handprints fitting into the affected areas across the body is summed to estimate the total percentage of involvement.	Baseline, Week 12
Change From Baseline in Dermatology Life Quality Index (DLQI)	The DLQI is a validated, dermatology-specific, patient-reported outcomes 10-item questionnaire that evaluates participants health-related quality of life over the past week. The 10 questions are grouped into 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories and corresponding scores are: Very much = 3; A lot = 2; A little = 1; Not at all = 0; Not relevant = 0. The total score is calculated by summing all 10 question responses and has a range of 0 (no impact of skin disease on quality of life) to 30 (maximum impact on quality of life).	Baseline, Week 12
Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406	Observed trough plasma concentration (Ctrough) of LY3972406.	Predose at Week 12

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 on - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2023
• Primary Completion (Actual): April 1, 2025
• Study Completion (Actual): May 6, 2025

Study Registration Dates

• First Submitted: December 11, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 20, 2023

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: September 29, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Psoriasis
• Other Study ID Numbers: 18692; J4H-MC-FVAA (Other Identifier: Eli Lilly and Company); 2023-504485-39-00 (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No