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Completed

NCT Number: NCT06176768

A Study of LY3972406 in Adult Participants 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.

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Key information

Conditions

Plaque Psoriasis

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dermatology Research Associates, Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3972406

Drug

Administered orally

Placebo

Drug

Administered orally

Primary outcomes

  1. Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)

    Time frame: Week 12

    • 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.

Secondary outcomes

  1. Change From Baseline in Percent Body Surface Area (BSA)

    Time frame: Baseline, Week 12

    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.

  2. Change From Baseline in Dermatology Life Quality Index (DLQI)

    Time frame: Baseline, Week 12

    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).

  3. Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406

    Time frame: Predose at Week 12

    Observed trough plasma concentration (Ctrough) of LY3972406.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 20, 2023
Registry last updated
Oct 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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