The trial is taking place at:
E

Etyka Osrodek Badan Klinicznych | Olsztyn, Poland

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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

Bristol-Myers Squibb (BMS) logo

Bristol-Myers Squibb (BMS)

Status and phase

Active, not recruiting
Phase 3

Conditions

Psoriatic Arthritis

Treatments

Drug: Deucravacitinib
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04908202
2020-005097-10 (EudraCT Number)
U1111-1259-9443 (Registry Identifier)
IM011-054

Details and patient eligibility

About

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.

Enrollment

650 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and 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 design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

650 participants in 2 patient groups, including a placebo group

Deucravacitinib
Experimental group
Treatment:
Drug: Deucravacitinib
Placebo
Placebo Comparator group
Treatment:
Other: Placebo

Trial contacts and locations

192

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Central trial contact

BMS Study Connect Contact Center www.BMSStudyConnect.com; First line of the email MUST contain NCT # and Site #.

Data sourced from clinicaltrials.gov

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