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

NCT05730725 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM032-0412023-504848-34U1111-1282-3606
• Study Type: interventional
• Target: 109
• Locations: 5 countries
• Sites: 35

Brief Summary

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

Conditions

Psoriasis

Keywords

Moderate-to-Severe Psoriasis; BMS-986322; TYK2 inhibitor

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (13)

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

  12 Weeks

• Percentage of Participants Achiving PASI-50 at Week 12

  12 Weeks

• Percentage of Participants Achiving PASI-90 at Week 12

  12 Weeks

• Percentage of Participants Achiving PASI-100 at Week 12

  12 Weeks

• Change of PASI-75 Scores Overtime

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

Study Arms (4)

BMS-986322 Dose 1

EXPERIMENTAL

Drug: BMS-986322

BMS-986322 Dose 2

EXPERIMENTAL

Drug: BMS-986322

BMS-986322 Dose 3

EXPERIMENTAL

Drug: BMS-986322

Placebo

PLACEBO COMPARATOR

Other: Placebo

Interventions

BMS-986322 DRUG

Specified dose on specified days

BMS-986322 Dose 1; BMS-986322 Dose 2; BMS-986322 Dose 3

Placebo OTHER

Specified dose on specified days

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (35)

Local Institution - 0006

Birmingham, Alabama, 35205-5021, United States

Location

Local Institution - 0012

Encino, California, 91436, United States

Location

Local Institution - 0005

Fountain Valley, California, 92708-3701, United States

Location

Local Institution - 0002

Fremont, California, 94538, United States

Location

Local Institution - 0001

Los Angeles, California, 90045-3606, United States

Location

Local Institution - 0016

Los Angeles, California, 90056, United States

Location

Local Institution - 0003

Santa Ana, California, 92701-2201, United States

Location

Local Institution - 0013

Coral Gables, Florida, 33134-5736, United States

Location

Local Institution - 0056

Skokie, Illinois, 60077-1049, United States

Location

Local Institution - 0044

Clarksville, Indiana, 47129-2201, United States

Location

Local Institution - 0057

Leawood, Kansas, 66211, United States

Location

Local Institution - 0004

Beverly, Massachusetts, 01915-1672, United States

Location

Local Institution - 0060

Lee's Summit, Missouri, 64064, United States

Location

Local Institution - 0007

Portsmouth, New Hampshire, 03801, United States

Location

Local Institution - 0055

Durham, North Carolina, 27713-8507, United States

Location

Local Institution - 0008

Cleveland, Ohio, 44106-1716, United States

Location

Local Institution - 0058

Rapid City, South Dakota, 57702-9208, United States

Location

Local Institution - 0059

Dallas, Texas, 75230-5808, United States

Location

Local Institution - 0011

Webster, Texas, 77598, United States

Location

Local Institution - 0024

Brisbane, Queensland, 4102, Australia

Location

Local Institution - 0019

Carlton, Victoria, 3053, Australia

Location

Local Institution - 0045

Pascoe Vale South, Victoria, 3044, Australia

Location

Local Institution - 0062

St. John's, Newfoundland and Labrador, A1E 1V4, Canada

Location

Local Institution - 0034

Barrie, Ontario, L4M 7G1, Canada

Location

Local Institution - 0020

Hamilton, Ontario, L8L 3C3, Canada

Location

Local Institution - 0041

London, Ontario, N6A 2C2, Canada

Location

Local Institution - 0030

Toronto, Ontario, M2N 3A6, Canada

Location

Local Institution - 0049

Sapporo, Hokkaido, 064-0807, Japan

Location

Local Institution - 0023

tabashi City, Tokyo, 1738606, Japan

Location

Local Institution - 0051

Fukuoka, 814-0180, Japan

Location

Local Institution - 0042

Itabashi-Ku, 173-8610, Japan

Location

Local Institution - 0026

Nagoya, 467-8602, Japan

Location

Local Institution - 0027

Tsu, 514-8507, Japan

Location

Local Institution - 0050

Hinckley, LEC, LE10 2SE, United Kingdom

Location

Local Institution - 0046

Leytonstone, E11 1NR, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: April 3, 2023
• Primary Completion: August 6, 2024
• Study Completion: August 6, 2024
• Last Updated: November 25, 2025
• Results First Posted: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

AU (3); GB (2); US (19); JP (6); CA (5)