Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
Condition: Active Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: BMS-986165 Placebo; BMS-986165 Dose A; BMS-986165 Dose B; Ustekinumab; Ustekinumab Placebo
Intervention description: Participants will receive BMS-986165 matching placebo QD; Participants will receive BMS-986165 Dose A QD.; Participants will receive BMS-986165 dose B QD.; Participants will receive ustekinumab SQ injection QD.; Participants will receive ustekinumab SQ matching placebo QD
Intervention MeSH terms: Ustekinumab; Deucravacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking description: Investigative site staff, the Sponsor, and Participant will remain blinded to treatment assignment with the exception of an unblinded pharmacist, an unblinded study drug administrator (Part B), and an unblinded site monitor.
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A
      or Dose B once daily [QD]) at Week 16 in the treatment of participants with active PsA.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with PsA for at least 6 months before screening, and who meet the
             Classification Criteria for Psoriatic Arthritis (CASPAR) at screening

          -  Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or
             (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi)
             (TNFi-experienced). Failure is defined as lack of response or loss of response with at
             least 3 months of therapy with an approved dose of a TNFi, as judged by the
             investigator. Failure must have occurred at least 2 months prior to Day 1

          -  Participants have at least 1 confirmed greater than or equal to (>=) 2 centimeter (cm)
             lesion of plaque psoriasis at screening

          -  Participants have active arthritis as shown by a minimum of >= 3 swollen joints and >=
             3 tender joints (66/68 joint counts) at screening and Day 1

          -  High sensitivity C-reactive protein (hsCRP) >= 3milligram per liter (mg/L) at
             screening

          -  Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy
             test within 24 hours prior to the start of study treatment

        Exclusion Criteria:

          -  Has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or
             drug-induced psoriasis) at screening or Day 1

          -  Has any other autoimmune condition such as rheumatoid arthritis, etc. There are
             exceptions for inflammatory bowel disease or uveitis as follows: currently active
             disease is excluded but, a history of no longer active disease for at least 12 months
             (including not being on medication) is allowed

          -  Has active (i.e. currently symptomatic) fibromyalgia

          -  History or evidence of active infection and/or febrile illness within 7 days prior to
             Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)

          -  History of recent serious bacterial, fungal, or viral infections requiring
             hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to
             screening, or any infection requiring antimicrobial treatment within 15 days prior to
             Day 1

          -  History of active tuberculosis (TB) prior to screening visit, regardless of completion
             of adequate treatment