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BMS-986322

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment109

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986322 · 6 trials · 3 indications

Phase 2 1Phase 1 5
NCT05730725A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe PsoriasisPsoriasis
COMPLETED109 Analytics
PHASE2COMPLETED
A Study to Evaluate Effectiveness and Safety of BMS-986322 in Participants With Moderate-to-Severe Psoriasis
PsoriasisUnlock trial analytics

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

Maximum observed in plasma/whole blood concentration (Cmax)
Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to day 17
Area under the plasma/whole blood concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to day 17
Time of maximum observed in plasma/whole blood concentration (T-max)
Up to day 17
Terminal elimination half-life (T-HALF)
Up to day 17
Apparent total body clearance (CL/F)
Up to day 17
Apparent volume of distribution of terminal phase (Vz/F)
Up to day 17
Percent of BMS-986322 plasma AUC(INF) relative to plasma radioactivity AUC(INF) (%AUC(INF))
Up to day 17
Total radioactivity (TRA) ratio of blood AUC(INF) to plasma AUC(INF)
Up to day 17
Total amount of radioactivity recovered in urine (UR)
Up to day 17
Percent of total amount of radioactivity recovered in urine (%UR)
Up to day 17
Total amount of radioactivity recovered in feces (FR)
Up to day 17
Percent of total amount of radioactivity recovered in feces (%FR)
Up to day 17
Total amount of radioactivity recovered in urine and feces combined (RTotal)
Up to day 17
Percent of total amount of radioactivity recovered in all excreta (%Total)
Up to day 17
Maximum observed plasma concentration (Cmax)
Up to 21 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Up to 21 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
Up to 21 days
Maximum observed plasma concentration (Cmax) for EE/NET
Up to 28 days
Cmax for EE/NET with BMS-986322
Up to 28 days
Area under the concentration-time curve in 1 dosing interval (AUC[tau]) for EE/NET
Up to 28 days
AUC (tau) for EE/NET with BMS-986322
Up to 28 days
Number of participants with serious adverse events (SAEs)
Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
Up to 7 weeks
Number of deaths
Up to 7 weeks
Number of participants with AEs
Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
Up to 7 weeks
Number of participants with vital sign abnormalities
Up to 7 weeks
Number of participants with physical examination abnormalities
Up to 7 weeks
Number of participants with clinical laboratory abnormalities
Up to 7 weeks
Incidence of Death
up to 12 months
Incidence of Adverse Effects (AEs)
up to 12 months
Incidence of Adverse Events leading to discontinuation
up to 12 months
Incidence of Serious Adverse Events (SAEs)
up to 12 months
Vital signs of body temperature
up to 12 months
Vital signs of blood pressure
up to 12 months
Vital signs of respiratory rate
up to 12 months
Number of Participants with abnormal physical examinations
up to 12 months
Number of clinically significant changes in Electrocardiograms (ECGs)
up to 12 months
Number of clinically significant changes in lab assessment of blood serum
up to 12 months
Number of clinically significant changes in lab assessment of urine
up to 12 months
Number of Clinically significant changes in lab assessment of blood
up to 12 months
Maximum concentration (Cmax) of BMS-986322 in Part C
up to 12 months
Time of maximum concentration (Tmax) of BMS-986322 in Part C
up to 12 months
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
up to 12 months
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
up to 12 months
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
up to 12 months
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
up to 12 months
Apparent oral clearance (CL/F) of BMS-986322 in Part C
up to 12 months
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
up to 12 months

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 -
Administration of BMS-986322EXPERIMENTAL -
Part 1: Rosuvastatin + BMS-986322EXPERIMENTAL -
Part 2: Metformin + BMS-986322 + GlucoseEXPERIMENTAL -
Part 3: Methotrexate + BMS-986322 + LeucovorinEXPERIMENTAL -
BMS-986322 and LoestrinEXPERIMENTALLoestrin, then progress to combination
Cohort J1EXPERIMENTAL -
Cohort J2EXPERIMENTAL -
Cohort J3EXPERIMENTAL -
Part A: BMS-986322EXPERIMENTAL -
Part B: BMS-986322 PlaceboEXPERIMENTAL -
Part C: BMS-986322 with famotidineEXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986322DRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
RosuvastatinDRUGSpecified dose on specified days
MetforminDRUGSpecified dose on specified days
GlucoseDIETARY_SUPPLEMENTSpecified dose on specified days
MethotrexateDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
LoestrinDRUGSpecified dose on specified days
Placebo for BMS-986322OTHERSpecified dose on specified days
BMS-986322 PlaceboOTHERSpecified Dose on Specified Days
famotidineDRUGSpecified Dose on Specified Days
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Eligibility Criteria

Age Range18 Years to 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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Frequently asked questions about BMS-986322

What is BMS-986322 used for?

BMS-986322 is an investigational small molecule being studied for the treatment of moderate-to-severe psoriasis. It has also been evaluated in clinical trials involving healthy participants to assess its drug levels, effects, safety, and interactions. The drug is not approved and remains in clinical development.

Who makes BMS-986322?

BMS-986322 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company has sponsored multiple clinical trials of the drug, including studies in healthy participants and in patients with moderate-to-severe psoriasis.

What phase is BMS-986322 in?

BMS-986322 is in Phase 1 and Phase 2 clinical development. It has completed Phase 1 trials in healthy participants and a Phase 2 trial in participants with moderate-to-severe psoriasis. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-986322 in?

BMS-986322 has completed four clinical trials. These include NCT04175925 and NCT05579574 in healthy participants, NCT05730725 in participants with moderate-to-severe psoriasis, and NCT06088264 in healthy adult male participants. All trials are completed, with a total enrollment of 313 participants.

Is BMS-986322 the same as any other drug?

BMS-986322 is the primary name used for this investigational drug in clinical trials. No alternative names have been reported in the available clinical trial information. It is a small molecule being studied for psoriasis and in healthy volunteer studies.