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

NCT06176768 | Completed Phase 2 Results FDA Drug

• 3 other identifiers: 18692J4H-MC-FVAA2023-504485-39-00
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 12

Brief Summary

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

Conditions

Plaque Psoriasis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change From Baseline in Percent Body Surface Area (BSA)

  Baseline, Week 12

• Change From Baseline in Dermatology Life Quality Index (DLQI)

  Baseline, Week 12

• Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406

  Predose at Week 12

Study Arms (2)

LY3972406

EXPERIMENTAL

Participants received an oral dose of LY3972406 for 12 weeks.

Drug: LY3972406

Placebo

PLACEBO COMPARATOR

Participants received an oral dose of placebo for 12 weeks.

Drug: Placebo

Interventions

LY3972406 DRUG

Administered orally

LY3972406

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (12)

Dermatology Research Associates

Los Angeles, California, 90045, United States

Location

Clinical Science Institute

Santa Monica, California, 90404, United States

Location

Driven Research

Coral Gables, Florida, 33134, United States

Location

Conquest Research

Winter Park, Florida, 32789, United States

Location

Psoriasis Treatment Center of Central New Jersey

East Windsor, New Jersey, 08520, United States

Location

Schweiger Dermatology Group

Hackensack, New Jersey, 07601, United States

Location

Metropolitan Dermatology - Clark

Kenilworth, New Jersey, 07033, United States

Location

Accellacare - Winston-Salem

Winston-Salem, North Carolina, 27103, United States

Location

Remington-Davis, Inc

Columbus, Ohio, 43215, United States

Location

DermDox Centers for Dermatology

Camp Hill, Pennsylvania, 17011, United States

Location

Center for Clinical Studies

Houston, Texas, 77004, United States

Location

Austin Institute for Clinical Research

Houston, Texas, 77056, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: December 6, 2023
• Primary Completion: April 1, 2025
• Study Completion: May 6, 2025
• Last Updated: October 15, 2025
• Results First Posted: October 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

US (12)