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

Phase 2

Completed

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.

Recruitment & Eligibility

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
Agree to skin biopsies

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

Arm && Interventions

Group	Intervention	Description
LY3972406	LY3972406	Participants received an oral dose of LY3972406 for 12 weeks.
Placebo	Placebo	Participants received an oral dose of placebo for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving ≥75% Reduction From Baseline in Psoriasis Area and Severity Index (PASI-75)	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 Outcome Measures

Name	Time	Method
Change From Baseline in Percent Body Surface Area (BSA)	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.
Change From Baseline in Dermatology Life Quality Index (DLQI)	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).
Pharmacokinetics (PK): Observed Trough Plasma Concentration of LY3972406	Predose at Week 12	Observed trough plasma concentration (Ctrough) of LY3972406.

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
Conquest Research
🇺🇸
Winter Park, Florida, United States
Psoriasis Treatment Center of Central New Jersey
🇺🇸
East Windsor, New Jersey, United States
Schweiger Dermatology Group
🇺🇸
Hackensack, New Jersey, United States
Metropolitan Dermatology - Clark
🇺🇸
Kenilworth, New Jersey, United States
Accellacare - Winston-Salem
🇺🇸
Winston-Salem, North Carolina, United States
Remington-Davis, Inc
🇺🇸
Columbus, Ohio, United States
DermDox Centers for Dermatology
🇺🇸
Camp Hill, Pennsylvania, United States
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Dermatology Research Associates
🇺🇸Los Angeles, California, United States