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

• Conditions: Active Psoriatic Arthritis; MedDRA version: 21.0Level: LLTClassification code 10037160Term: Psoriatic arthritisSystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2020-005099-36-HU
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-08
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 1166

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) 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

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

Other protocol-defined inclusion/exclusion criteria apply

Study & Design

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