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Active (not recruiting) Phase 3 NCT04908189

A Study to Determine the 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 TNFα Inhibitor Treatment

Phase 3 – large-scale trial before approval
Conditions: Psoriatic Arthritis

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
Overview
The purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.
Who can participate
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 * Must have completed the week 52 treatment for the optional open-label long-term extension period 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, rheumatoid arthritis, 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
Locations 18
Argentina (1)
Local Institution - 0048
La Plata , Buenos Aires
Australia (1)
Local Institution - 0003
Botany , New South Wales
Belgium (1)
Local Institution - 0078
Brussels
Canada (1)
Local Institution - 0111
Vancouver , British Columbia
China (1)
Local Institution - 0126
Bengbu , Anhui
Colombia (1)
Local Institution - 0072
Barranquilla , Atlántico
Czech Republic (1)
Local Institution - 0010
Brno
Germany (1)
Local Institution - 0176
Ratingen , North Rhine-Westphalia
Hungary (1)
Local Institution - 0025
Veszprém , Veszprém City
Italy (1)
Azienda Ospedaliera Universitaria Careggi-Reumatologia
Florence
Japan (1)
Local Institution - 0202
Nagoya , Aichi-ken
Mexico (1)
Local Institution - 0052
León , Guanajuato
Poland (1)
Local Institution - 0082
Bydgoszcz , Kuyavian-Pomeranian Voivodeship
Russia (1)
Local Institution
Moscow
Spain (1)
Local Institution - 0014
Barcelona
Taiwan (1)
Local Institution - 0090
Taichung
United Kingdom (1)
Local Institution - 0185
London , England
United States (1)
Local Institution - 0149
Mountain Brook , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
15.07.2021
Completion date
12.11.2026
Registry ID
NCT04908189
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.