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

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

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

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: BMS-986322

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Local Institution - 0024
  • Victoria
    • Carlton, Victoria, Australia, 3053
      • Local Institution - 0019
    • Pascoe Vale South, Victoria, Australia, 3044
      • Local Institution - 0045
• Canada
  • Newfoundland and Labrador
    • St. John's, Newfoundland and Labrador, Canada, A1E 1V4
      • Local Institution - 0062
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Local Institution - 0034
    • Hamilton, Ontario, Canada, L8L 3C3
      • Local Institution - 0020
    • London, Ontario, Canada, N6A 2C2
      • Local Institution - 0041
    • Toronto, Ontario, Canada, M2N 3A6
      • Local Institution - 0030
• Japan
  • Fukuoka, Japan, 814-0180
    • Local Institution - 0051
  • Itabashi-Ku, Japan, 173-8610
    • Local Institution - 0042
  • Nagoya, Japan, 467-8602
    • Local Institution - 0026
  • Tsu, Japan, 514-8507
    • Local Institution - 0027
  • Hokkaido
    • Sapporo, Hokkaido, Japan, 064-0807
      • Local Institution - 0049
  • Tokyo
    • tabashi City, Tokyo, Japan, 1738606
      • Local Institution - 0023
• United Kingdom
  • Leytonstone, United Kingdom, E11 1NR
    • Local Institution - 0046
  • LEC
    • Hinckley, LEC, United Kingdom, LE10 2SE
      • Local Institution - 0050
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205-5021
      • Local Institution - 0006
  • California
    • Encino, California, United States, 91436
      • Local Institution - 0012
    • Fountain Valley, California, United States, 92708-3701
      • Local Institution - 0005
    • Fremont, California, United States, 94538
      • Local Institution - 0002
    • Los Angeles, California, United States, 90045-3606
      • Local Institution - 0001
    • Los Angeles, California, United States, 90056
      • Local Institution - 0016
    • Santa Ana, California, United States, 92701-2201
      • Local Institution - 0003
  • Florida
    • Coral Gables, Florida, United States, 33134-5736
      • Local Institution - 0013
  • Illinois
    • Skokie, Illinois, United States, 60077-1049
      • Local Institution - 0056
  • Indiana
    • Clarksville, Indiana, United States, 47129-2201
      • Local Institution - 0044
  • Kansas
    • Leawood, Kansas, United States, 66211
      • Local Institution - 0057
  • Massachusetts
    • Beverly, Massachusetts, United States, 01915-1672
      • Local Institution - 0004
  • Missouri
    • Lee's Summit, Missouri, United States, 64064
      • Local Institution - 0060
  • New Hampshire
    • Portsmouth, New Hampshire, United States, 03801
      • Local Institution - 0007
  • North Carolina
    • Durham, North Carolina, United States, 27713-8507
      • Local Institution - 0055
  • Ohio
    • Cleveland, Ohio, United States, 44106-1716
      • Local Institution - 0008
  • South Dakota
    • Rapid City, South Dakota, United States, 57702-9208
      • Local Institution - 0058
  • Texas
    • Dallas, Texas, United States, 75230-5808
      • Local Institution - 0059
    • Webster, Texas, United States, 77598
      • Local Institution - 0011

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Specified dose on specified days
Experimental: BMS-986322 Dose 1	Drug: BMS-986322; Specified dose on specified days
Experimental: BMS-986322 Dose 2	Drug: BMS-986322; Specified dose on specified days
Experimental: BMS-986322 Dose 3	Drug: BMS-986322; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	approximately 5 months
Number of Participants With AE Indicating Clinical Laboratory Abnormality	Number of participants with AE indicating clinical laboratory abnormality	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	approximately 5 months
Number of Participants With Clinically Significant Changes From Baseline in Vital Signs Evaluations	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	approximately 5 months
Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations	Number of participants with clinically significant changes from baseline in physical examination evaluations	approximately 5 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	12 Weeks
Change of PASI-75 Scores Overtime	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.	From start of treatment (Week 1) to Week 2, 4, 8 and 12
Change of PASI-90 Scores Overtime	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.	From start of treatment (Week 1) to Week 2, 4, 8 and 12
Change of PASI-100 Scores Overtime	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.	From start of treatment (Week 1) to Week 2, 4, 8 and 12
Change of PASI-50 Scores Overtime	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.	From start of treatment (Week 1) to Week 2, 4, 8 and 12
Mean Change Frome Baseline of PASI Scores Overtime	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.	From start of treatment (Week 1) to Week 2, 4, 8, and 12
Ctrough Measurements Overtime	trough observed plasma concentration	From start of treatment (Week 1) to Week 2, 4, 8 and 12
Cmax at Day 15	maximum observed concentration	At Day 15 post first dose
Tmax at Day 15	time to maximum observed concentration	At Day 15 post first dose
AUC(Tau) at Day 15	area under the plasma concentration-time curve over the dosing interval	At Day 15 post first dose

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Actual): August 6, 2024
• Study Completion (Actual): August 6, 2024

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Estimated): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: TYK2 inhibitor; BMS-986322; Moderate-to-Severe Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis
• Other Study ID Numbers: IM032-041; U1111-1282-3606 (Registry Identifier: WHO); 2023-504848-34 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trialsand research/disclosurecommitment.html
• IPD Sharing Time Frame: See Plan Description
• IPD Sharing Access Criteria: See Plan Description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No