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Deucravacitinib

Phase 3

Plaque Psoriasis | Small molecule | Immunology |Bristol-Myers Squibb Company|Last Updated: May 28, 2026

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-BlindACTIVE_CONTROLLEDDMCBiomarker
Total Trials3
Total Enrollment3,559
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06979453A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque PsoriasisPHASE3 RECRUITING 366 — — Dec 3, 2025Aug 12, 2034May 28, 2026123 United States, Argentina +14
NCT07116967Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)PHASE3 RECRUITING 3,040 — — Sep 22, 2025Jan 16, 2031May 27, 2026363 United States, Argentina +23
NCT04772079A Study to Evaluate the Drug Levels, Efficacy and Safety of Deucravacitinib in Pediatric Participants With Moderate to Severe Plaque PsoriasisPHASE3 RECRUITING 153 — — Mar 23, 2021Sep 8, 2033Sep 25, 202563 Argentina, Australia +11
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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

Geometric mean observed average concentration at steady state (Cavg.ss) for deucravacitinib at Week 2
Week 2

Part A

Maximum observed plasma concentration at steady state (Cmax.ss) for deucravacitinib at Week 2
Week 2

Part A

Trough observed plasma concentration (Ctrough) 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

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
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Administration of DeucravacitinibACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Active treatment deucravacitinib standard doseEXPERIMENTAL -
Active treatment deucravacitinib half-standard doseEXPERIMENTAL -
Interventions
NameTypeDescription
DeucravacitinibDRUGSpecified dose on specified days
PlaceboOTHERSpecified dose on specified days
UstekinumabDRUGSpecified dose on specified days
Placebo matching deucravacitinibOTHERSpecified dose on specified days
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Eligibility Criteria
Age Range12 Years — 17 Years
SexALL
Healthy VolunteersNo
Study Sites123

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 Kingdom
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Recent Changes (Last 90 Days)
LOWMay 29, 2026NCT06979453lastUpdatePostDate: changed
LOWMay 29, 2026NCT06979453lastUpdatePostDate: changed
LOWMay 29, 2026NCT06979453lastUpdatePostDate: changed
LOWMay 28, 2026NCT07116967lastUpdatePostDate: changed
LOWMay 28, 2026NCT07116967lastUpdatePostDate: changed
LOWMay 26, 2026NCT04772079primaryCompletionDate: changed
LOWMay 26, 2026NCT06979453primaryCompletionDate: changed
LOWMay 26, 2026NCT07116967primaryCompletionDate: changed
LOWMay 24, 2026NCT04772079studyFirstPostDate: changed
LOWMay 24, 2026NCT06979453studyFirstPostDate: changed
LOWMay 24, 2026NCT07116967studyFirstPostDate: changed