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Deucravacitinib

Phase 3

Psoriatic Arthritis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: Jul 14, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials2
Total Enrollment1,399
FDA Designations
No designations recorded
Clinical trial landscape

Deucravacitinib · 15 trials · 12 indications

Phase 3 9Phase 2 3Phase 1 3
NCT06979453A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque PsoriasisPlaque Psoriasis
RECRUITING366 Analytics
NCT07116967Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)Plaque Psoriasis
RECRUITING3,040 Analytics
NCT06869551A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic ArthritisJuvenile Psoriatic Arthritis
RECRUITING60 Analytics
NCT05946941A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's SyndromeSjögren's Syndrome
ACTIVE NOT_RECRUITING774 Analytics
NCT05617677A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)Systemic Lupus Erythematosus
ACTIVE NOT_RECRUITING516 Analytics
NCT05620407A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus ErythematosusSystemic Lupus Erythematosus
ACTIVE NOT_RECRUITING513 Analytics
NCT04908189A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor TreatmentPsoriatic Arthritis
ACTIVE NOT_RECRUITING729 Analytics
NCT04908202A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic DrugsPsoriatic Arthritis
ACTIVE NOT_RECRUITING670 Analytics
NCT04772079A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque PsoriasisPlaque Psoriasis
RECRUITING153 Analytics
PHASE3RECRUITING
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
PHASE3RECRUITING
Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)
Plaque PsoriasisUnlock trial analytics
PHASE3RECRUITING
A Study to Evaluate the Drug Levels, Efficacy, and Safety of Deucravacitinib (BMS-986165) in Pediatric Participants With Juvenile Psoriatic Arthritis
Juvenile Psoriatic ArthritisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate the Efficacy and Safety of Deucravacitinib in Adults With Active Sjögren's Syndrome
Sjögren's SyndromeUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Assess Effectiveness and Safety of Deucravacitinib Compared With Placebo in Participants With Active Systemic Lupus Erythematosus (SLE)
Systemic Lupus ErythematosusUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Evaluate Effectiveness and Safety of Deucravacitinib (BMS-986165) Compared With Placebo in Participants With Active Systemic Lupus Erythematosus
Systemic Lupus ErythematosusUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Psoriatic ArthritisUnlock trial analytics
PHASE3ACTIVE NOT_RECRUITING
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
Psoriatic ArthritisUnlock trial analytics
PHASE3RECRUITING
A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Children and Adolescent Participants With Moderate to Severe Plaque Psoriasis
Plaque PsoriasisUnlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75)
At week 16
Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline
At week 16
Composite cardiovascular adjudicated 3-point major adverse cardiovascular event (MACE) plus coronary revascularization
Up to 5 years

MACE defined as non-fatal myocardial infarction \[MI\], nonfatal stroke, and cardiovascular death

Time to first flare during the withdrawal period
From week 16 up to week 42
Change from baseline in European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) Score at Week 52
Baseline, Week 52
Proportion of participants who achieve Systemic Lupus Erythematosus Responder Index-4 [SRI(4)] response
At week 52
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
Week 16

The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.

Percentage of Participants With ACR 20 Response at Week 16
Week 16

The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.

Observed average concentration at steady state for deucravacitinib at Week 2
Week 2

Part A

Maximum observed plasma concentration at steady state for deucravacitinib at Week 2
Week 2

Part A

Trough observed plasma concentration for deucravacitinib at Week 2
Week 2

Part A

Proportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) at Week 16
Week 16

Part B

Proportion of subjects with an static Physician's Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16
Week 16

Part B

Incidence of Adverse Events (AEs)
Up to 316 weeks

Long-term extension (LTE) Period

Incidence of serious adverse events (SAEs)
Up to 316 weeks

LTE Period

Monitoring of growth: Body weight
Up to 316 weeks

LTE Period

Monitoring of growth: Height
Up to 316 weeks

LTE Period

Monitoring of growth: Tanner staging (sexual maturation)
Up to 316 weeks

LTE Period

Changes in IFNγ in CA scalp
Baseline to Week 24

Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in CCL5 in CA scalp
Baseline to Week 24

Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in CXCL9 in CA scalp
Baseline to Week 24

Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in CXCL10 in CA scalp
Baseline to Week 24

Changes in TH1 markers in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in TGFB1/2 in CA scalp
Baseline to Week 24

Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in vimentin in CA scalp
Baseline to Week 24

Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in fibronectin CA scalp
Baseline to Week 24

Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24

Changes in CTGF in CA scalp
Baseline to Week 24

Changes in biomarkers of fibrosis in Cicatricial Alopecias on the scalp from Baseline to Week 24

Percentage Change From Baseline in CLASI Activity Score at Week 16
From first dose to Week 16 (approximately 16 weeks)

The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a validated clinical tool designed to assess skin involvement in cutaneous lupus erythematosus (CLE). It separately scores: * Disease activity (e.g., erythema, scale, mucous membrane involvement, alopecia) * Damage (e.g., dyspigmentation, scarring) CLASI enables classification of disease severity: Mild: Activity score 0-9 Moderate: 10-20 Severe: 21-70

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From first dose to 30 days post last dose (Up to 110 weeks)

Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment

Number of Participants With Laboratory Abnormalities
From first dose to 30 days post last dose (Up to 110 weeks)

Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.

Number of Participants With Electrocardiogram (ECG) Abnormalities
From first dose to 30 days post last dose (Up to 110 weeks)
Number of Participants With Vital Signs Abnormalities
From first dose to 30 days post last dose (Up to 110 weeks)
Change From Baseline in Laboratory Parameters
Baseline, Week 12, Week 108

Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function

Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate
Baseline, Week 48, Week 96

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate

Change From Baseline in Electrocardiogram (ECG) Parameters
Baseline, Week 48, Week 96

Changes from IM011077 study baseline in electrocardiogram (ECG) parameters

Change From Baseline in Vital Signs Parameters - Heart Rate
Baseline, Week 12, Week 108

Changes from IM011077 study baseline in vital signs parameters - heart rate

Change From Baseline in Vital Signs Parameters
Baseline, Week 12, Week 108

Changes from IM011077 study baseline in vital signs parameters

Maximum observed plasma concentration (Cmax)
Up to day 20
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
Up to day 20
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
Up to day 20
Concentration at 24 hours post dose (C24)
Up to approximately 5 days
Area under the concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]
Up to approximately 5 days
Maximum Observed Plasma Concentration (Cmax) of deucravacitinib
Up to 7 days
Area Under the Concentration-time Curve from time 0 to 24 hours postdose (AUC(0-24)) of deucravacitinib
Up to 7 days
Concentration at 24 hours of post-morning dose on Day 1 and Day 7 (C24) of deucravacitinib
Up to 7 days
Secondary Endpoints
Number of participants achieving at least 90% improvement in PASI (PASI 90)
At week 16
Change from baseline in PASI
At week 16
Change from baseline in body surface area (BSA) involvement
At week 16
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Administration of DeucravacitinibACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Deucravacitinib, Dose 1EXPERIMENTAL -
Deucravacitinib, Dose 2EXPERIMENTAL -
Placebo, followed by Deucravacitinib Dose 1 or Dose 2PLACEBO_COMPARATOR -
Arm 1: DeucravacitinibEXPERIMENTAL -
Arm 2: PlaceboPLACEBO_COMPARATOR -
DeucravacitinibEXPERIMENTAL -
ApremilastOTHER -
Active treatment deucravacitinib standard doseEXPERIMENTAL -
Active treatment deucravacitinib half-standard doseEXPERIMENTAL -
Central Centrifugal Cicatricial AlopeciaEXPERIMENTALContains individuals diagnosed with Central Centrifugal Cicatricial Alopecia.
Frontal Fibrosing AlopeciaEXPERIMENTALContains individuals diagnosed with Frontal Fibrosing Alopecia.
Active Treatment: Deucravacitinib Dose 1EXPERIMENTAL -
Active Treatment: Deucravacitinib Dose 2EXPERIMENTAL -
Long-Term Extension Rollover Study: DeucravacitinibEXPERIMENTAL -
BMS-986165 Formulation 1EXPERIMENTAL -
BMS-986165 Formulation 2EXPERIMENTAL -
BMS-986165 Formulation 2 + FedEXPERIMENTAL -
BMS-986165 Formulation 2 + FamotidineEXPERIMENTAL -
Part A: DeucravacitinibEXPERIMENTAL -
Part B: DeucravacitinibEXPERIMENTAL -
Part AEXPERIMENTAL -
Part BEXPERIMENTAL -
Part CEXPERIMENTAL -
Part DEXPERIMENTAL -
Interventions
NameTypeDescription
DeucravacitinibDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
UstekinumabDRUGSpecified dose on specified days
ApremilastDRUGSpecified dose on specified days
Placebo matching deucravacitinibOTHERSpecified dose on specified days
FamotidineDRUGSpecified dose on specified days
Unlock Study Design Details
Eligibility Criteria
Age Range12 Years to 17 Years
SexALL
Healthy VolunteersNo
Study Sites129

Inclusion Criteria * Participants must have stable plaque psoriasis for 6 months or more prior to Screening. * Participants must have moderate to severe psoriasis defined by:. i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1. ii) Static Physician's Global Assessmen...

Countries:United StatesArgentinaBelgiumBrazilCanadaChinaColombiaGermanyHungaryItalyMexicoPolandPuerto RicoRomaniaSpainTaiwanAustraliaBulgariaChileCzechiaDenmarkFranceJapanSouth KoreaSwedenUnited KingdomTurkey (Türkiye)AustriaFinlandGreeceIsraelNetherlandsPeruPortugalSwitzerlandHong KongIndiaIrelandLithuaniaMoldovaSingaporeThailandRussia
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Recent Changes (Last 90 Days)
LOWJul 14, 2026NCT06979453lastUpdatePostDate: changed
LOWJul 14, 2026NCT06979453lastUpdatePostDate: changed
LOWJul 7, 2026NCT07116967lastUpdatePostDate: changed
LOWJul 7, 2026NCT07116967lastUpdatePostDate: changed
LOWJun 26, 2026NCT06869551lastUpdatePostDate: changed
LOWJun 26, 2026NCT06869551lastUpdatePostDate: changed
LOWJun 18, 2026NCT06979453lastUpdatePostDate: changed
LOWJun 18, 2026NCT06979453lastUpdatePostDate: changed
LOWJun 18, 2026NCT06979453lastUpdatePostDate: changed
LOWJun 16, 2026NCT07116967lastUpdatePostDate: changed
LOWJun 16, 2026NCT07116967lastUpdatePostDate: changed
LOWJun 16, 2026NCT07116967lastUpdatePostDate: changed
LOWJun 11, 2026NCT06869551lastUpdatePostDate: changed
LOWJun 11, 2026NCT06869551lastUpdatePostDate: changed
LOWJun 9, 2026NCT04772079lastUpdatePostDate: changed
LOWJun 9, 2026NCT04772079lastUpdatePostDate: changed
LOWJun 9, 2026NCT04772079lastUpdatePostDate: changed
LOWJun 9, 2026NCT04772079lastUpdatePostDate: changed
LOWMay 29, 2026NCT06979453lastUpdatePostDate: changed
LOWMay 29, 2026NCT06979453lastUpdatePostDate: changed