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BMS-986322

Phase 2

Psoriasis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Nov 25, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment109
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05730725A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe PsoriasisPHASE2 COMPLETED 109Apr 3, 2023Aug 6, 2024Nov 25, 202535 United States, Australia +3
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Study Endpoints
Primary Endpoints
Percentage of Participants Achiving PASI-75 at Week 12
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.

Number of Participants With Safety Related Events
approximately 85 days

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

Number of Participants With TEAE by Worst Intensity
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.

Number of Participants With AE Indicating Clinical Laboratory Abnormality
approximately 5 months

Number of participants with AE indicating clinical laboratory abnormality

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

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

Number of Participants With Clinically Significant Changes From Baseline in Physical Examination Evaluations
approximately 5 months

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

Secondary Endpoints
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
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BMS-986322 Dose 1EXPERIMENTAL -
BMS-986322 Dose 2EXPERIMENTAL -
BMS-986322 Dose 3EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
BMS-986322DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites35

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 * P...

Countries:United StatesAustraliaCanadaJapanUnited Kingdom
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