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
- Conditions
- Active Psoriatic ArthritisMedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-005099-36-CZ
- Lead Sponsor
- Bristol-Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1166
• 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) atScreening
• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 979
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 187
• 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
Other protocol-defined inclusion/exclusion criteria apply
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:<br>- as assessed by DAS28-CRP<br>- as assessed by HAQ-DI<br>- as assessed by PASI 75 response<br>- as assessed by SF-36 PCS score<br>- in enthesitis resolution<br>- in MDA response<br>- in FACIT-Fatigue<br>- in dactylitis resolution<br>;Primary end point(s): Proportion of participants meeting American College of Rheumatology improvement of 20% (ACR20);Timepoint(s) of evaluation of this end point: At Week 16
- Secondary Outcome Measures
Name Time Method