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: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Other: Placebo; Drug: BMS-986322

• Study Type: Interventional
• Enrollment (Estimated): 120
• 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-shi, Japan, 814-0180
    • Local Institution - 0051
  • Itabashi-Ku, Japan, 173-8610
    • Local Institution - 0042
  • Nagoya-Shi, Japan, 467-8602
    • Local Institution - 0026
  • Tsu City, Japan, 514-8507
    • Local Institution - 0027
  • Hokkaido
    • Sapporo-Shi, Hokkaido, Japan, 064-0807
      • Local Institution - 0049
  • Tokyo
    • Itabashi, 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	Time Frame
Proportion of participants achieving 75% reduction in PASI score (PASI-75)	At week 12
Number of participants with treatment-emergent adverse event (TEAEs)	Up to 16 weeks
Number of participants with serious adverse events (SAEs)	Up to 16 weeks
Number of participants with TEAEs leading to treatment discontinuation	Up to 16 weeks
Number of participants with clinical laboratory abnormalities	Up to 16 weeks
Number of participants with electrocardiogram (ECG) abnormalities	Up to 16 weeks
Number of participants with vital sign abnormalities	Up to 16 weeks
Number of participants with physical examination abnormalities	Up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants achieving sPGA score of 0 or 1	At week 12
Proportion of participants achieving 50% reduction in PASI score (PASI-50)	At week 12
Proportion of participants achieving 90% reduction in PASI score (PASI-90)	At week 12
Proportion of participants achieving 100% reduction in PASI score (PASI-100)	At week 12
Proportion of participants achieving PASI-50	Up to week 12
Proportion of participants achieving PASI-75	Up to week 12
Proportion of participants achieving PASI-90	Up to week 12
Proportion of participants achieving PASI-100	Up to week 12
Change from baseline in PASI score	Up to week 12
BMS-986322 trough concentrations	Up to week 12
Maximum observed plasma concentration (Cmax) of BMS-986322	At day 15
Area under the plasma concentration-time curve over the dosing interval [AUC(TAU)] of BMS-986322	At day 15
Time of maximum observed plasma concentration (Tmax) of BMS-986322	At day 15

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 (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 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 (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: TYK2 inhibitor; BMS-986322; Moderate-to-Severe Psoriasis
• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; 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