Efficacy and Safety of BMS-986165 Compared with Placebo in Subjects with Active Psoriatic Arthritis (PsA)

INTERVENTION: Product Name: BMS‐986165 Product Code: BMS‐986165 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: BMS‐986165 CAS Number: 1609392‐28‐0 Other descriptive name: BMS986165 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Product Name: BMS‐986165 Product Code: BMS‐986165 Pharmaceutical Form: Film‐coated tablet INN or Proposed INN: BMS‐986165 CAS Number: 1609392‐28‐0 Other descriptive name: BMS986165 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12‐ Pharmaceutical form of the placebo: Film‐coated tablet Route of administration of the placebo: Oral use Trade Name: Stelara Product Name: Ustekinumab Pharmaceutical Form: Solution for infusion INN or Proposed INN: USTEKINUMAB CAS Number: 815610‐63‐0 Other descriptive name: USTEKINUMAB Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 5‐ Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Subcutaneous use CONDITION: Psoriatic Arthritis ; MedDRA version: 20.0 Level: LLT Classification code 10037160 Term: Psoriatic arthritis System Organ Class: 100000004859 Therapeutic area: Diseases [C] ‐ Immune System Diseases [C20] PRIMARY OUTCOME: Main Objective: Assess the dose‐response relationship of BMS‐986165 (6 or 12 mg once daily [QD]) at Week 16 in the treatment of subjects with active PsA Primary end point(s): ACR 20 response Secondary Objective: Assess the dose‐response relationship of BMS‐986165 (6 or 12 mg QD) at Week 16 in daily functional activities; Assess the dose‐response relationship of BMS‐986165 (6 or 12 mg QD) at Week 16 in reducing PSO severity; Assess the dose‐response relationship of BMS‐986165 (6 or 12 mg QD) at Week 16 in Patient‐reported Outcomes; Timepoint(s) of evaluation of this end point: Week 16 SECONDARY OUTCOME: Secondary end point(s): Change from baseline in HAQ‐DI score ; PASI 75 response ; Change from baseline in the Physical Component Summary (PCS) score of the SF‐36 Questionnaire ; Timepoint(s) of evaluation of this end point: Throughout the study INCLUSION CRITERIA: 1.Signed Written Informed Consent 2.Type of Participant and Target Disease Characteristics Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening. Subjects either (i) cannot have prior exposure to biologics (biologic‐naïve) or (ii) have failed or been intolerant to 1 TNF‐inhibitor (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. Subjects have at least 1 confirmed = 2 cm lesion of plaque psoriasis at screening. Subjects 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) = 3mg/L at screening. If on a conventional non‐biologic DMARD (eg