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-BE
- 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
??Participant has been diagnosed to have PsA (by any criteria) of at least 3 months duration at Screening.
??Participant meets the CASPAR criteria at Screening.
??Participant has active plaque psoriatic skin lesion(s) or documented medical history of plaque PsO at Screening.
??Participant has active arthritis as shown by = 3 swollen joints and = 3 tender joints (66/68 joint counts) at Screening and Day 1.
??Participant has hsCRP = 3 mg/L at Screening.
??Participant has had documented inadequate response, loss of response or intolerance to at least 1 of the following:
•?A csDMARD at maximally tolerated dose, and/or apremilast, after a minimum of 12 weeks duration of therapy given for the treatment of PsA
•?An NSAID after a minimum of 4 weeks duration of therapy given for the treatment of PsA, or participant has intolerance to those treatments in the opinion of the investigator
•?A TNF-inhibitor after a minimum of 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar), or a minimum of 14 weeks (i.e., at least 4 doses) of infliximab (or biosimilar) given for the treatment of PsA and/or PsO. A shorter duration may be considered if documentation of inadequate response can be obtained and provided to the Medical Monitor for review
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
??Participant has non-plaque PsO (ie, guttate, pustular, erythrodermic or drug-induced PsO) at Screening or Day 1.
??Participant has any other autoimmune condition such as, systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis.
??Participant has prior history of or current inflammatory joint disease other than PsA (eg, gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease).
??Participant has active (ie, currently symptomatic) fibromyalgia whose symptoms or therapy will significantly impact the assessment of PsA disease manifestations and activity in the opinion of the investigator.
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 ACR 20 response ;Timepoint(s) of evaluation of this end point: At Week 16
- Secondary Outcome Measures
Name Time Method