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

Phase 1

Recruiting

• Conditions: Active Psoriatic Arthritis; Therapeutic area: Diseases [C] - Immune System Diseases [C20]; MedDRA version: 21.0Level: LLTClassification code: 10037160Term: Psoriatic arthritis Class: 10028395

• Registration Number: CTIS2023-506257-37-00
• Lead Sponsor: Bristol Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1110

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

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, rheumatoidarthritis, ankylosing spondylitis, Lyme disease), Active fibromyalgia, Received an approved or investigational biologic therapy for the treatment of PsA or PsO

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare the efficacy of deucravacitinib to placebo in the treatment of participants with active PsA;Secondary Objective: To compare the efficacy of deucravacitinib to placebo at Week 16 as assessed by DAS28-CRP, To compare the efficacy of deucravacitinib to placebo at Week 16 as assessed by HAQ-DI., To compare the efficacy of deucravacitinib to placebo at Week 16 as assessed by PASI 75 response., To compare the efficacy of deucravacitinib to placebo at Week 16 as assessed by SF-36 PCS score., To compare the efficacy of deucravacitinib to placebo at Week 16 in enthesitis resolution., To compare the efficacy of deucravacitinib to placebo at Week 16 in MDA response, To compare the efficacy of deucravacitinib to placebo at Week 16 in FACIT-Fatigue, To compare the efficacy of deucravacitinib to placebo at Week 16 in dactylitis resolution;Primary end point(s): Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20)