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Purpose

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening. - Meets the Classification Criteria for Psoriatic Arthritis 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. - ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading. - Must have completed the week 52 treatment for the optional open-label long-term extension period.

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. - Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Deucravacitinib
  • Drug: Deucravacitinib
    Specified dose on specified days
    Other names:
    • BMS-986165
Placebo Comparator
Placebo
  • Other: Placebo
    Specified dose on specified days

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Bristol-Myers Squibb

Study Contact

BMS Study Connect Contact Center www.BMSStudyConnect.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.