Efficacy and Safety of Deucravacitinib Compared with Placebo in Participants with Active Psoriatic Arthritis (PsA) who are Naive to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFa Inhibitor Treatment

A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants with Active Psoriatic Arthritis (PsA) who are Naive to Biologic Disease Modifying Anti-rheumatic Drugs or had Previously Received TNFa Inhibitor Treatment

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031210418

Enrollment

700

Registered

2021-11-09

Start date

2022-03-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Interventions

Drug:Deucravacitinib(BMS-986165) Specified dose on specified days,Oral

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening -Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening -Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening -Active arthritis as shown by >- 3 swollen joints and >- 3 tender joints at Screening and Day 1 -Participant has high sensitivity C-reactive protein (hsCRP) >- 3 mg/L at Screening

Exclusion criteria

Exclusion criteria: -Nonplaque psoriasis at Screening or Day 1 -Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis -History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease) -Active fibromyalgia -Received an approved or investigational biologic therapy for the treatment of PsA or PsO

Design outcomes

Primary

Measure	Time frame
Proportion of participants meeting ACR20 response at week16	—

Secondary

Measure	Time frame
-Change from baseline DAS28-CRP [ Time Frame: At week 16 ] -Change from baseline HAQ-DI [ Time Frame: At week 16 ] -Proportion of participants meeting ACR20/50/70 response[ Time Frame: Up to 16 weeks ] -Proportion of participants meeting PASI 75/90/100 response [ Time Frame: Up to 16 weeks ] -Incidence of AEs/SAEs [Time Frame: Up to Week 52 ]	—

Countries

Argentina, Australia, Belgium, Canada, China, Colombia, Czech Republic, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Taiwan, UK, USA

Contacts

Public ContactMiroslawa Nowak

Bristol-Myers Squibb

MG-JP-RCO-JRCT@bms.com+81-120-093-507

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026