A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Bristol-Myers Squibb109 enrolled

Overview

The purpose of this study is to evaluate clinical effectiveness and safety of BMS-986322 in participants with moderate-to-severe psoriasis.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

109

Conditions

Psoriasis

Interventions

BMS-986322DRUG

Specified dose on specified days

PlaceboOTHER

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of plaque psoriasis (PsO) for ≥ 6 months * Body mass index 18 to 40 kg/m\^2 and total body weight \> 50 kg (110 lbs) * Deemed by Investigator to be eligible for phototherapy or systemic therapy * Psoriatic plaques must cover ≥ 10% of body surface area at baseline * Psoriasis Area and Severity Index (PASI) score ≥ 12 and static Physician Global Assessment (sPGA) ≥ 3 at baseline Exclusion Criteria: * Diagnosis of non-plaque psoriasis (guttate, inverse, pustular, erythrodermic) * Diagnosis of uveitis, inflammatory bowel disease, or other immune-mediated conditions that are commonly associated with PsO for which a participant requires current systemic immunosuppressant medical treatment * Any significant acute or chronic medical illness Other protocol-defined inclusion/exclusion criteria apply

Locations (35)

Outcomes

Primary Outcomes

Percentage of Participants Achiving PASI-75 at Week 12

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-75 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 75% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Time frame: 12 Weeks

Number of Participants With Safety Related Events

Treatment related adverse events, serious adverse events and treatment related adverse events leading to treatment discontinuation are considered safety related events.

Time frame: approximately 85 days

Number of Participants With TEAE by Worst Intensity

Mild TEAE: An event that is easily tolerated by the participant, causing minimal discomfort, and not interfering with everyday activities. Moderate TEAE:An event that causes sufficient discomfort and interferes with normal everyday activities. Severe TEAE: An event that prevents normal everyday activities. An AE that is assessed as severe should not be confused with an SAE. Severe is a category utilized for rating the intensity of an event, and both AEs and SAEs can be assessed as severe.

Time frame: approximately 5 months

Number of Participants With AE Indicating Clinical Laboratory Abnormality

Number of participants with AE indicating clinical laboratory abnormality

Time frame: approximately 5 months

Number of Participants With Clinically Significant Changes From Baseline in ECG Evaluations.

Number of participants with clinically significant changes from baseline in ECG evaluations. ECG results for participants with any result outside of a pre-specified range and investigator identified abnormalities will be listed for the Safety Population. The following criteria will be used to determine ECG results that are outside of a pre-specified range: * PR (msec): Value \> 200 * QRS (msec): Value \> 120 * QT (msec): Value \> 500 or change from baseline \> 30 * QTcF (msec): Value \> 450 or change from baseline \> 30

Data from ClinicalTrials.gov

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Secondary Outcomes

Percentage of Participants Achiving sPGA Score of 0 or 1 at Week 12

The static Physician's Global Assessment(sPGA) The sPGA is used to assess a participant's psoriasis lesions at a specific time point. Lesions are graded based on three characteristics: Erythema (E) Induration (I) Scaling (S) Each is scored individually, and the average of the three scores, rounded to the nearest whole number, determines the final sPGA score. 0 = No evidence 1= Minimal 2 = Mild 3 = Moderate 4 = Severe. The lower the score the better.

Time frame: 12 Weeks

Percentage of Participants Achiving PASI-50 at Week 12

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-50 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 50% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Time frame: 12 Weeks

Percentage of Participants Achiving PASI-90 at Week 12

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-90 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 90% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Time frame: 12 Weeks

Percentage of Participants Achiving PASI-100 at Week 12

PASI is a measure of the average erythema, induration thickness, and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI-100 response rate is defined as the percentage of participants with moderate-to-severe PsO achieving at least 100% reduction from baseline in PASI score. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Time frame: 12 Weeks

Change of PASI-75 Scores Overtime