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BMS-986165

Phase 3

Psoriasis | Small molecule | Dermatology |Bristol-Myers Squibb Company|Last Updated: Mar 20, 2026

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Trial Design
RandomizedDouble-BlindCONTROLLEDDMC
Total Trials9
Total Enrollment3,783
FDA Designations
No designations recorded
Clinical trial landscape

BMS-986165 · 33 trials · 18 indications

Phase 3 5Phase 2 5Phase 1 23
NCT04167462An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South KoreaPsoriasis
COMPLETED220 Analytics
NCT04036435Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With PsoriasisPsoriasis
ACTIVE NOT_RECRUITING1,466 Analytics
NCT03924427An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe PsoriasisPsoriasis
COMPLETED74 Analytics
NCT03624127Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With PsoriasisPsoriasis
COMPLETED666 Analytics
NCT03611751An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque PsoriasisPsoriasis
COMPLETED1,020 Analytics
PHASE3COMPLETED
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo in Participants With Plaque Psoriasis (POETYK-PSO-3) in Mainland China, Taiwan, and South Korea
PsoriasisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With Psoriasis
PsoriasisUnlock trial analytics
PHASE3COMPLETED
An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe Psoriasis
PsoriasisUnlock trial analytics
PHASE3COMPLETED
Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With Psoriasis
PsoriasisUnlock trial analytics
PHASE3COMPLETED
An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque Psoriasis
PsoriasisUnlock trial analytics
Study Endpoints
Primary Endpoints
The Percentage of Participants With sPGA Response of 0 or 1
At week 16

static Physician Global Assessment (sPGA) 0 or 1 response assessed as a percentage of participants with a sPGA score of 0 or 1 as assessed at week 16 with at least a 2-point improvement from baseline. The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The sPGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A higher score equates to higher severity of disease. The individual scores at each visit will range from 0-4 and will be captured for erythema, induration, and scaling. A total score will also be computed based on the average of the 3 characteristic scores. The average score will be rounded to the nearest whole number and data for this endpoint will be derived from the total average score.

The Percentage of Participants With PASI 75 Response
At week 16

Psoriasis Area and Severity Index (PASI) 75 response is an assessment defined as the percentage of participants who experience at least a 75% improvement in PASI score at Week 16 as compared with baseline value. PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions graded on a scale from 0-4 (0= absent symptoms, 1= mild symptoms, 2= moderate symptoms, 3= severe symptoms, 4= very severe symptoms), 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 includes multiple subscores and a final total score. Individual plaque characteristic rating scores are provided for each body region as well as the weighted score. The PASI Total score will be used to assess response to treatment.

Incidence of Adverse Events (AEs)
Up to 244 weeks
Incidence of Serious Adverse Events (SAEs)
Up to 244 weeks
Proportion of participants achieving a satisfactory humoral response: pneumococcus
At Week 4 post vaccination

Vaccine cohort only Defined as ≥ 2-fold increase in immunoglobulin (IgG) antibody titers or geometric mean fold rise (GMFRs) titers of ≥ 6

Proportion of participants achieving a satisfactory humoral response: tetanus titers
At Week 4 post vaccination

Vaccine cohort only A serologic response is defined as: * Postvaccination titer levels ≥ 0.40 IU/mL if prevaccination IgG antibody titer level is ≤ 0.10 IU/mL OR * Postvaccination titer levels of at least a 4-fold increase if prevaccination titer level is \> 0.10 IU/mL and ≤ 2.7 IU/mL OR * Postvaccination titer levels of at least a 2-fold increase if prevaccination titer level is \> 2.7 IU/mL

Static Physician's Global Assessment (sPGA) 0/1 Response as a Number of Participants With a sPGA Score of 0 or 1 at Week 16
Week 16

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as clear (0) or almost clear (1) with at least 2-point improvement from baseline at week 16 using the non-responder imputation (NRI) method. The higher sPGA score denotes to more severe disease activity: * Clear (0) * Almost clear (1) * Mild (2) * Moderate (3) * Severe (4)

Psoriasis Area and Severity Index (PASI) 75 Response Assessed as a Number of Participants Who Achieve a 75% Improvement From Baseline in the PASI Score at Week 16
Week 16

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method.

The Number of Participants With a Static Physician's Global Assessment (sPGA) Score of 0 or 1 in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (sPGA 0/1)
Week 16

The sPGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The average of the 3 scales, which is rounded to the nearest whole number, is the final sPGA score. The higher sPGA score denotes to more severe disease activity (0 = Clear; 1 = Almost clear; 2 = Mild; 3 = Moderate; Severe = 4). sPGA 0/1 is the response as a number of participants who experience a sPGA score that determines psoriasis severity as 0 or 1 with at least 2-point improvement from baseline using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason.

The Number of Participants Who Achieve a 75% Improvement From Baseline in the Psoriasis Area and Severity Index (PASI) Score in Participants Receiving BMS-986165 Compared to Placebo at Week 16 (PASI 75)
Baseline and Week 16

PASI is a measure of the average redness, thickness, and scaliness of psoriatic skin lesions (each graded on a 0 to 4 scale; 0 = none to 4 = very severe), weighted by the area of involvement (head, upper extremities, trunk, and lower extremities). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. PASI 75 is the response as a number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value using the non-responder imputation (NRI) method that will be used for participants who discontinue treatment or study prior to week 16 or who have missing week 16 endpoint data for any reason. Baseline is defined as the measurement at the randomization visit (Week 0).

Percentage of Participants in Clinical Response at Week 12
At week 12

Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment) * A decrease from baseline in the modified Mayo score of ≥ 2 points, and * A decrease from baseline in the modified Mayo score ≥ 30%, and * A decrease in rectal bleeding (RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components: * Stool frequency (SF) subscore (0 to 3) * Rectal bleeding (RB) subscore (0 to 3) * Endoscopic (ES) subscore (0 to 3)

Number of Participants Experiencing Adverse Events (AEs)
From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

Number of Participants Experiencing Serious Adverse Events (SAEs)
From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation
From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days)

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period.

Number of Participants Experiencing Adverse Events of Special Interest (AEIs)
From first dose to 52 weeks after first dose

An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19.

Clinical Remission Response Rate at Week 12
From first dose to 12 weeks.

Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1

Number of Participants With Treatment-Emergent Adverse Events and Treatment Emergent Serious Adverse Events
From Day 1 until 30 days after last dose (up to approximately 42 months)

A Treatment-Emergent Adverse Event (TEAE) is any untoward medical occurrence that begins or worsens after the first dose of study treatment, including any unfavorable sign, symptom, disease, or abnormal lab finding, whether or not related to the product, and may include worsening of pre-existing conditions. A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening, requires or prolongs hospitalization, causes persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect, or is considered an important medical event requiring intervention to prevent these outcomes.

Number of Participants With Abnormalities in Vital Signs
From Day 1 until 30 days after last dose (up to approximately 42 months)

Vital signs heart rate (HR) (beats/min), systolic blood pressure (SBP) (mmHG), and diastolic blood pressure (DBP) (mmHg).

Number of Participants With Grade 3 or Grade 4 Laboratory Abnormalities
From Day 1 until 30 days after last dose (up to approximately 42 months)

Blood samples were collected to assess laboratory parameters. Grade 3 = Severe laboratory abnormality Grade 4 = Life-threatening or very severe laboratory abnormality

Number of Participants Who Meet Response Criteria for Systemic Lupus Erythematosus (SLE) Responder Index [SRI(4)] at Week 32
At week 32

SRI(4) responder is defined as a patient whose disease course fulfills all of the following: 1. A 4-point or greater reduction from baseline in SLEDAI-2K score 2. No new British Isles Lupus Assessment Group (BILAG) A (severe disease activity) and not more than 1 new BILAG B (moderate disease activity) organ domain grade 3. No worsening from baseline in the Physician's Global Assessment of Disease Activity Scale by more than 0.3 points on a 3-point visual analog scale from no disease activity to severe disease activity

The Percentage of Participants With Moderate to Severe Psoriasis Experiencing a 75% Improvement (Reduction From Baseline) in PASI Score (PASI-75 Response Rate) on Day 85 (Week 12)
Day 1 to Day 85

Psoriasis Area and Severity Index (PASI) 75 response: patients who achieved ≥ 75% improvement (reduction) in PASI score compared to baseline were defined as PASI 75 responders. PASI scores can range from 0, corresponding to no signs of psoriasis up to theoretical maximum of 72.0, which means a higher PASI score reflects a higher psoriasis activity.

Number of Participants With Adverse Events
Day 1 to day 115

The safety and tolerability of BMS-986195 as assessed by the number of subjects with adverse events (AEs); number of subjects with serious adverse events (SAEs); number of subjects with adverse events leading to discontinuation

Maximum observed plasma concentration (Cmax) in plasma for metformin with and without BMS-986165
Up to 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC (0-T)) in plasma for metformin with and without BMS-986165
Up to 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for metformin with and without BMS-986165
Up to 9 days
Maximum concentration (Cmax) for BMS-986165 in plasma
Up to 18 days
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (AUC(0-T)) for BMS-986165 in plasma
Up to 18 days
Area under the plasma concentration-time curve extrapolated to infinity (AUC(INF)) for BMS-986165 in plasma
Up to 18 days
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Day 1 to Day 13
Maximum observed plasma concentration (Cmax) for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for a tablet dosed with high-fat high-calorie meal versus fasted condition
Day 1 to Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet dosed with high-fat high-calorie meal versus fasted condition
Day 1 to Day 13
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) in plasma for BMS-986165 for tablet administered fasted after pretreatment with famotidine vs administered alone
Day 1 to Day 13
Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor
Up to 14 days
Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor
up to 14 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
up to 14 days
Maximum observed serum comcentration (Cmax)
Day 1, Day 5
Area under the concentration-time curve from time zero extrapolated to AUC(INF)
Day 1, Day 5
Maximum observed plasma concentration (Cmax) of BMS-986165
Day 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165
Day 1
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165
Day 1
Maximum observed plasma concentration of BMS-986165 in combination with steady-state ritonavir
Day 15
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration of BMS-986165 in combination with steady-state ritonavir
Day 15
Area under the plasma concentration-time curve from time zero extrapolated to infinite time in BMS-986165 in combination with steady-state ritonavir
Day 15
Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUC[0-T]) of BMS-986165
Day 1 and Day 9
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time (AUC[INF]) of BMS-986165
Day 1 and Day 9
AUC(0-T) of BMS-986165
10 days
AUC(INF) of BMS-986165
10 days
Maximum observed plasma concentration (Cmax)
Approximately 9 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)]
Approximately 9 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
Approximately 9 days
Time to Maximum Observed Plasma Concentration (Tmax) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Area Under The Plasma Concentration-Time Curve From Time Zero Extrapolated To Infinite Time (AUC(INF)) of BMS-986165
Day 1 to Day 4
Apparent Plasma Elimination Half-Life (T-HALF) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Apparent Oral Total Body Clearance (CLT/F) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(INF) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[INF])
Day 1 to Day 4
Metabolic Ratio for Cmax of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(Cmax)
Days 1 to 4, Day 5, and Day 19
Apparent Volume of Distribution (Vz/F) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Area Under the Plasma Concentration-Time Curve in a Dosing Interval (AUC(TAU)) of BMS-986165
Day 5 and Day 19
Effective Elimination Half-Life (T-HALFeff) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Trough Observed Plasma Concentration (Ctrough) of BMS-986165
Day 2 to 20
Average Plasma Concentration at Steady State (Css-avg) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Accumulation Index (AI) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Metabolic Ratio for AUC(TAU) of Metabolite (BMT-153261 and BMT-158170) Over Parent (BMS-986165) - MR(AUC[TAU])
Day 5 to Day 19
Degree of Fluctuation (DF) of BMS-986165
Days 1 to 4, Day 5, and Day 19
Maximum observed plasma concentration (Cmax) of BMS-986165 following Treatments A, B, C, and D
Determined over 5 days
Time of maximum observed plasma concentration (Tmax) of BMS-986165 following Treatments A, B, C, and D
Determined over 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986165 following Treatments A, B, C, and D
Determined over 5 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986165 following Treatments A, B, C, and D
Determined over 5 days
Apparent plasma elimination half-life (T-HALF) of BMS-986165 following Treatments A, B, C, and D
Determined over 5 days
Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data
4 days
Taste properties of BMS-986165 alone & in prototypes to determine Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria
Approximately 2 years
Taste properties of BMS-986165 alone & in prototypes to determine amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria
Approximately 2 years
Taste properties of BMS-986165 alone & in prototypes to determine mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria
Approximately 2 years
Taste properties of BMS-986165 alone & in prototypes to determine off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria
Approximately 2 years
Taste properties of BMS-986165 alone & in prototypes to determine aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria
Approximately 2 years
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
18 days
AUC extrapolated to infinity (AUC[INF]) of MPA
18 days
Placebo-corrected change from baseline in (Fridericia) QT Interval (QTcF) for BMS-986165 as determined by 12-lead electrocardiogram (ECG)
From baseline to 5 days
Maximum concentration (Cmax)
24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
24 hours
Time to attain maximum observed plasma concentration (Tmax)
Approximately 14 days
Area under the plasma concentration-time curve up to time T, where T is the last point with concentrations above the lower limit of quantitation [AUC(0-T)]
Approximately 14 days
Area under the plasma concentration-time curve from time 0 to infinity [AUC(INF)]
Approximately 14 days
Terminal elimination rate constant (kel)
Approximately 14 days
Terminal elimination half life, calculated as 0.693/kel (T-HALF)
Approximately 14 days
Apparent oral clearance (CL/F)
Approximately 14 days
Maximum observed plasma concentration (Cmax) derived from plasma concentration versus time
5 days
AUC from time zero extrapolated to infinity [AUC(INF)] derived from plasma concentration versus time
5 days
Area under the plasma concentration-time curve (AUC) from time zero to time of last quantifiable concentration [AUC(0-T)] derived from plasma concentration versus time
5 days
Time of maximum observed plasma concentration (Tmax) derived from plasma concentration versus time
5 days
Maximum concentration (Cmax) derived from plasma concentration versus time
Approximately 1 day
Area under the plasma concentration-time curve to the end of the dosing period [AUC(tau)] derived from plasma concentration versus time
Approximately 1 day
Cmax (Maximum observed plasma concentration) of Rosuvastatin.
Up to Day 13

Measured by plasma concentration.

AUC(0-T) (Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration) of Rosuvastatin.
Up to Day 13

Measured by plasma concentration.

AUC(INF) (Area under the plasma concentration-time curve from time zero extrapolated to infinite time) of Rosuvastatin.
Up to Day 13

Measured by plasma concentration.

The primary endpoint is PK exposure that will be determined from plasma concentration versus time
Day 1 to Day 13
Urinary/fecal TRA (Total radioactivity) recovery data
Day 1 to Day 13
PK terminal elimination half-life data (T-HALF)
Day 1 to Day 13
PK apparent total body clearance (CL/F)
Day 1 to Day 13
PK apparent volume of distribution (Vz/F)
Day 1 to Day 13
PK time of maximum observed plasma concentration (Tmax)
Day 1 to Day 13
Safety of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months

Adverse Event (AE), Serious adverse event (SAE)

Tolerability of a single oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Safety of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Tolerability of a multiple oral dose of BMS-986165 based on number of incidence of AE, SAEs, AEs leading to discontinuation or death, marked abnormalities in clinical laboratory tests, vital sign measurements, ECGs, telemetry, and physical examinations
Approximately 3 months
Secondary Endpoints
The Percentage of Participants With PASI 90 Response
At week 16
The Percentage of Participants With PASI 100 Response
At week 16
The Percentage of Participants With sPGA 0 Response
At week 16
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A:BMS-986165 oral administrationEXPERIMENTAL -
Arm B: Placebo oral administrationPLACEBO_COMPARATOR -
BMS-986165EXPERIMENTAL -
Vaccine CohortEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
ApremilastACTIVE_COMPARATOR -
Active comparatorACTIVE_COMPARATORActive comparator oral administration
Open label Extension, BMS-986165EXPERIMENTAL -
BMS-986165 Dose 1EXPERIMENTAL -
BMS-986165 Dose 2EXPERIMENTAL -
BMS-986165 Dose 3EXPERIMENTAL -
BMS-986165 Dose 1 oral administrationEXPERIMENTAL -
BMS-986165 Dose 2 oral administrationEXPERIMENTAL -
BMS-986165 Dose 3 oral administrationEXPERIMENTAL -
Placebo oral administrationPLACEBO_COMPARATOR -
BMS-986165 Dose 4EXPERIMENTALSpecified dose of BMS-986165 on specified days.
BMS-986165 Dose 5EXPERIMENTALSpecified dose of BMS-986165 on specified days.
Arm 1: BMS-986165 Dose 1 + MetforminEXPERIMENTAL -
Arm 2: BMS-986165 Dose 2 + MetforminEXPERIMENTAL -
Treatment A : BMS-986165EXPERIMENTAL -
Treatment B: BMS-986165 prototype 1EXPERIMENTAL -
Treatment C: BMS-986165 prototype 2EXPERIMENTAL -
Treatment D: BMS-986165 prototype 2EXPERIMENTAL -
Treatment A: BMS-986165 alone, fastedEXPERIMENTAL -
Treatment B: BMS-986165 alone, fedEXPERIMENTAL -
Treatment C: BMS-986165 with famotidine pretreatment, fastedEXPERIMENTAL -
Arm A: Single Dose (BMS-986165)EXPERIMENTAL -
Arm B:Diflunisal and Single Dose (BMS-986165)EXPERIMENTAL -
BMS- 986185 + PyrimethamineEXPERIMENTAL -
BMS-986185EXPERIMENTAL -
Combination TherapyEXPERIMENTAL -
BMS-986165 + RabeprazoleEXPERIMENTAL -
BMS-986165+FluvoxamineEXPERIMENTAL -
BMS-986165 onlyEXPERIMENTAL -
Fluvoxamine onlyEXPERIMENTAL -
Normal renal functionEXPERIMENTALSingle dose
Mild renal diseaseEXPERIMENTALSingle dose
Moderate renal failureEXPERIMENTALSingle dose
Severe renal failureEXPERIMENTALSingle dose
End-stage renal disease requiring dialysisEXPERIMENTALTwo single doses administered with washout
Group 1: BMS-986165 Dose 1EXPERIMENTALParticipants will receive Dose 1 on Day 1, and from Day 5 - 19.
Group 2: BMS-986165 Dose 2EXPERIMENTALParticipants will receive Dose 2 on Day 1, and from Day 5 - 19.
Group 1: Placebo Dose 1PLACEBO_COMPARATORParticipants will receive placebo matching Dose 1 on Day 1, and from Day 5 - 19.
Group 2: Placebo Dose 2PLACEBO_COMPARATORParticipants will receive placebo matching Dose 2 on Day 1, and from Day 5 - 19.
Normal liver functionEXPERIMENTALSingle dose
Mild liver impairmentEXPERIMENTALSingle dose
Moderate liver impairmentEXPERIMENTALSingle dose
Severe liver impairmentEXPERIMENTALSingle dose
Formulation AEXPERIMENTALDosage formulation and area of release varies between arms
Formulation BEXPERIMENTALDosage formulation and area of release varies between arms
Formulation CEXPERIMENTALDosage formulation and area of release varies between arms
Formulation DEXPERIMENTALDosage formulation and area of release varies between arms
Formulation EEXPERIMENTALDosage formulation and area of release varies between arms
Formulation FEXPERIMENTALDosage formulation and area of release varies between arms
Formulation GEXPERIMENTALDosage formulation and area of release varies between arms
Formulation HEXPERIMENTALDosage formulation and area of release varies between arms
BMS-986165 taste evaluationEXPERIMENTALBMS-986165 taste evaluation using Active Pharmaceutical Ingredient (API) and Prototypes of the API containing various flavors and sweeteners
BMS-986165 + MMFEXPERIMENTALOral administration
Moxifloxacin Dose 3 oral administrationACTIVE_COMPARATORMoxifloxacin positive control single dose
Placebo Dose 4 oral administrationPLACEBO_COMPARATORPlacebo single dose
BMS-986165 and cyclosporineEXPERIMENTALBMS-986165 and cyclosporine administered orally
BMS-986165+Methotrexate+LeucovorinEXPERIMENTALThree treatments administered
Tablet-Capsule Crossover 1EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 2EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 3EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 4EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 5EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
Tablet-Capsule Crossover 6EXPERIMENTALVariations between arms dependent on timing, fasting, dose and receiving the tablet or capsule at different treatment period combinations
BMS-986165 and Oral ContraceptiveEXPERIMENTALOral administration of contraceptive, then progress to combination
BMS 986165 and RosuvastatinEXPERIMENTAL -
Single dose of radiolabeled BMS-986165EXPERIMENTAL -
Part A: Single ascending doseEXPERIMENTALBMS-986165 or Placebo specified dose on specified days
Part B: Multiple ascending doseEXPERIMENTALBMS-986165 or Placebo + Interferon alpha-2a recombinant specified dose on specified days
Part C: Multiple ascending doseEXPERIMENTALBMS-986165 or Placebo specified dose on specified days
Part D: Relative BioavailabilityEXPERIMENTALBMS-986165 (Liquid) + BMS-986165 (Capsule) + Famotidine specified dose on specified days
Interventions
NameTypeDescription
BMS-986165DRUGSpecified dose on Specified Days
PlaceboOTHERSpecified dose on Specified days
ApremilastDRUGSpecified dose on specified days
Placebo ComparatorOTHERSpecified Dose on Specified Days
Placebo for BMS-986165DRUG -
MetforminDRUGSpecified dose on specified days
BMS-986165 prototype 1DRUGSpecified dose on specified days
BMS-986165 prototype 2DRUGSpecified dose on specified days
FamotidineDRUGSingle dose
diflunisalDRUGSpecified Dose on Specified Days
PyrimethamineDRUGOral administration of Pyrimethamine in combination with BMS-986185
RitonavirDRUG100 mg
RabeprazoleDRUGSpecified dose on specified days.
FluvoxamineDRUGParticipants will receive fluvoxamine.
Active Pharmaceutical IngredientDRUGSwish and expectorate after tasting
MMFDRUGSpecified dose on specified days
MoxifloxacinDRUGSpecified dose on specified days
CyclosporineDRUGSpecified dose on specified days
MethotrexateDRUGSpecified dose on specified days
LeucovorinDRUGSpecified dose on specified days
BMS-986165 CapsuleDRUGOral capsule
BMS-986165 TabletDRUGOral tablet
Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)DRUGOral Contraceptive
RosuvastatinDRUGRosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
Interferon alpha-2a recombinantDRUG -
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites34

Inclusion Criteria: * Plaque psoriasis for at least 6 months * Moderate to severe disease * Candidate for phototherapy or systemic therapy Exclusion Criteria: * Other forms of psoriasis * History of recent infection * Prior exposure to BMS-986165 Other inclusion/exclusion criteria may apply.

Countries:ChinaSouth KoreaTaiwanUnited StatesAustraliaCanadaCzechiaFinlandFranceGermanyHungaryIsraelJapanNew ZealandPolandPuerto RicoRussiaSpainSwedenUnited KingdomItalyNetherlandsBelgiumArgentinaBrazilColombiaMexicoRomaniaLatviaSlovakia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04036435primaryCompletionDate: changed
LOWMay 24, 2026NCT04036435studyFirstPostDate: changed
MEDIUMMay 21, 2026NCT03920267TRIAL_REMOVED: changed
MEDIUMMay 21, 2026NCT03920267TRIAL_REMOVED: changed