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

Study Purpose

The purpose of this study is to evaluate the efficacy and safety of deucravacitinib versus placebo in participants with active psoriatic arthritis who are naïve to biologic disease-modifying anti-rheumatic drugs. The long term extension period will provide additional long-term efficacy and safety information.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

- Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at screening.

- Meets the Classification Criteria for Psoriatic Arthritis 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.

- ≥ 1 PsA-related hand and/or foot joint erosion on X-ray during Screening Period that is confirmed by central reading.

- 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04908202
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 3
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Bristol-Myers Squibb
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Bristol-Myers Squibb
Principal Investigator Affiliation	Bristol-Myers Squibb
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	Argentina, Australia, Brazil, Bulgaria, Chile, China, Colombia, Czechia, Finland, France, Hungary, Ireland, Italy, Mexico, Poland, Romania, Russian Federation, Spain, Taiwan, United Kingdom, United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Psoriatic Arthritis
Study Website:	View Trial Website

Arms & Interventions

Arms

Experimental: Deucravacitinib

Placebo Comparator: Placebo

Interventions

Drug: - Deucravacitinib

Specified dose on specified days

Other: - Placebo

Specified dose on specified days

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gilbert, Arizona

Status

Recruiting

Address

Arizona Arthritis & Rheumatology Associates

Gilbert, Arizona, 85297

Site Contact

Joonhee Lim, Site 0197

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