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Completed

NCT Number: NCT05730725

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

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

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Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0024, Brisbane, Queensland, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

BMS-986322

Drug

Specified dose on specified days

Placebo

Other

Specified dose on specified days

Primary outcomes

  1. Percentage of Participants Achiving PASI-75 at Week 12

    Time frame: 12 Weeks

    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.

  2. Number of Participants With Safety Related Events

    Time frame: approximately 85 days

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

  3. Number of Participants With TEAE by Worst Intensity

    Time frame: approximately 5 months

    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.

  4. Number of Participants With AE Indicating Clinical Laboratory Abnormality

    Time frame: approximately 5 months

    Number of participants with AE indicating clinical laboratory abnormality

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

    Time frame: approximately 5 months

    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

  6. Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations

    Time frame: approximately 5 months

    Number of participants with clinically significant changes from baseline in vital signs evaluations.

    Vital signs for participants with any out-of-range result will be listed for the Safety Population.

    The following criteria will be used to determine vital sign results that are outside of a prespecified range, where changes from baseline are based on matched postural positions:

    • Heart Rate (bpm): Value > 100 and change from baseline > 30, or Value < 55 and change from baseline < -15
    • Systolic blood pressure (mmHg): Value > 140 and change from baseline > 20, or Value < 90 and change from baseline < -20
    • Diastolic blood pressure (mmHg): Value > 90 and change from baseline > 10, or Value < 55 and change from baseline < -10
    • Respiration (breaths/min): Value > 16 or change from baseline > 10
    • Temperature (°C): Value > 38.3 or change from baseline > 1.6

  7. Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations

    Time frame: approximately 5 months

    Number of participants with clinically significant changes from baseline in physical examination evaluations

Secondary outcomes

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

    Time frame: 12 Weeks

    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.

  2. Percentage of Participants Achiving PASI-50 at Week 12

    Time frame: 12 Weeks

    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.

  3. Percentage of Participants Achiving PASI-90 at Week 12

    Time frame: 12 Weeks

    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.

  4. Percentage of Participants Achiving PASI-100 at Week 12

    Time frame: 12 Weeks

    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.

  5. Change of PASI-75 Scores Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 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.

  6. Change of PASI-90 Scores Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 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.

  7. Change of PASI-100 Scores Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 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.

  8. Change of PASI-50 Scores Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 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.

  9. Mean Change Frome Baseline of PASI Scores Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8, and 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.

    Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

  10. Ctrough Measurements Overtime

    Time frame: From start of treatment (Week 1) to Week 2, 4, 8 and 12

    trough observed plasma concentration

  11. Cmax at Day 15

    Time frame: At Day 15 post first dose

    maximum observed concentration

  12. Tmax at Day 15

    Time frame: At Day 15 post first dose

    time to maximum observed concentration

  13. AUC(Tau) at Day 15

    Time frame: At Day 15 post first dose

    area under the plasma concentration-time curve over the dosing interval

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase 2 Study to Evaluate the Clinical Efficacy and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 16, 2023
Registry last updated
Nov 25, 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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