NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210418

Registered date:09/11/2021

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

Basic Information

Recruitment status Not Recruiting
Health condition(s) or Problem(s) studiedPsoriatic Arthritis
Date of first enrollment18/03/2022
Target sample size700
Countries of recruitmentUSA,Japan,Spain,Japan,Germany,Japan,Italy,Japan,UK,Japan,Poland,Japan,Czech Republic,Japan,Russia,Japan,Hungary,Japan,Mexico,Japan,Taiwan,Japan,Argentina,Japan,China,Japan,Colombia,Japan,Belgium,Japan,Australia,Japan,Canada,Japan
Study typeInterventional
Intervention(s)Drug:Deucravacitinib(BMS-986165) Specified dose on specified days,Oral

Outcome(s)

Primary OutcomeProportion of participants meeting ACR20 response at week16
Secondary Outcome-Change from baseline DAS28-CRP [ Time Frame: At week 16 ] -Change from baseline HAQ-DI [ Time Frame: At week 16 ] -Proportion of participants meeting ACR20/50/70 response[ Time Frame: Up to 16 weeks ] -Proportion of participants meeting PASI 75/90/100 response [ Time Frame: Up to 16 weeks ] -Incidence of AEs/SAEs [Time Frame: Up to Week 52 ]

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include 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
Exclude 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

Related Information

Contact

Public contact
Name Miroslawa Nowak
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail MG-JP-RCO-JRCT@bms.com
Affiliation Bristol-Myers Squibb
Scientific contact
Name Miroslawa Nowak
Address 1-2-1 Otemachi, Chiyoda-ku, Tokyo Tokyo Japan 100-0004
Telephone +81-120-093-507
E-mail mg-jp-clinical_trial@bms.com
Affiliation Bristol-Myers Squibb