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

Eli Lilly and Company33 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Plaque Psoriasis

Interventions

LY3972406DRUG

Administered orally

PlaceboDRUG

Administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (12)

Dermatology Research Associates

Los Angeles, California, United States

Clinical Science Institute

Santa Monica, California, United States

Driven Research

Coral Gables, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: Week 12

Secondary Outcomes

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.

Time frame: 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).

Data from ClinicalTrials.gov

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