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BMS-986165

Phase 3

Psoriasis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Oct 20, 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-BlindCONTROLLEDDMCBiomarker
Total Trials9
Total Enrollment3,783
FDA Designations
No designations recorded
Clinical Trials (9)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
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 KoreaPHASE3 COMPLETED 220Nov 25, 2019Jan 7, 2022Mar 8, 202334 China, South Korea +1
NCT04036435Long-Term Study That Measures the Safety and Efficacy of Deucravacitinib (BMS-986165) in Participants With PsoriasisPHASE3 ACTIVE NOT_RECRUITING 1,466Aug 12, 2019Jul 26, 2026Oct 20, 2025302 United States, Australia +18
NCT03924427An Investigational Study to Evaluate Experimental Medication BMS-986165 in Japanese Participants With Moderate-to-Severe PsoriasisPHASE3 COMPLETED 74Apr 10, 2019Mar 24, 2021Nov 2, 202227 Japan
NCT03624127Effectiveness and Safety of BMS-986165 Compared to Placebo and Active Comparator in Participants With PsoriasisPHASE3 COMPLETED 666Aug 7, 2018Sep 2, 2020Jan 30, 2023165 United States, Canada +9
NCT03611751An Investigational Study to Evaluate Experimental Medication BMS-986165 Compared to Placebo and a Currently Available Treatment in Participants With Moderate-to-Severe Plaque PsoriasisPHASE3 COMPLETED 1,020Jul 26, 2018Nov 30, 2020Dec 20, 2022205 United States, Australia +14
NCT02931838Study to Evaluate Effectiveness and Safety in Subjects With Moderate to Severe PsoriasisPHASE2 COMPLETED 268Nov 15, 2016Nov 16, 2017Nov 27, 202076 United States, Australia +6
NCT03873415Assessment of Gut Absorption of Experimental Medication BMS-986165 in Healthy MalesPHASE1 COMPLETED 9Jan 25, 2019May 1, 2019Nov 26, 20191 United States
NCT03419910An Investigational Study of Cyclosporine on Experimental Medication BMS-986165 in Healthy Male ParticipantsPHASE1 COMPLETED 54Mar 5, 2018May 4, 2018Mar 18, 20201 United States
NCT03004768Pharmacokinetics and Metabolism of [14C]BMS-986165 in Healthy Male ParticipantsPHASE1 COMPLETED 6Jan 26, 2017Feb 27, 2017Feb 12, 20181 United States
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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).

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) 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
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
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
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
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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
BMS-986165 Dose 1EXPERIMENTALSpecified dose of BMS-986165 on specified days.
BMS-986165 Dose 2EXPERIMENTALSpecified dose of BMS-986165 on specified days.
BMS-986165 Dose 3EXPERIMENTALSpecified dose of BMS-986165 on specified days.
BMS-986165 Dose 4EXPERIMENTALSpecified dose of BMS-986165 on specified days.
BMS-986165 Dose 5EXPERIMENTALSpecified dose of BMS-986165 on specified days.
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 and cyclosporineEXPERIMENTALBMS-986165 and cyclosporine administered orally
Single dose of radiolabeled BMS-986165EXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986165DRUGSpecified dose on Specified Days
PlaceboOTHERSpecified dose on Specified days
ApremilastDRUGSpecified dose on specified days
Placebo for BMS-986165DRUG -
CyclosporineDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — 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 KingdomItalyLatviaMexico
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04036435primaryCompletionDate: changed
LOWMay 24, 2026NCT04036435studyFirstPostDate: changed