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

Part of paid clinical trials in Mountain Brook, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT04908189
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Deucravacitinib — DRUG
    Specified dose on specified days
  • Placebo — OTHER
    Specified dose on specified days
  • Apremilast — DRUG
    Specified dose on specified days

Study Details

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.

Key Dates

Start date
Jul 15, 2021
Status verified
Jun 2025
Primary completion
Feb 6, 2024
Completion
Nov 12, 2026

Study Design

Enrollment
729 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Deucravacitinib
  • Placebo Comparator: Placebo
  • Other: Apremilast

Primary Outcome Measure

Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 [ Time Frame: Week 16 ]

Locations (24)

FacilityCityStateZIPSite coordinators
Local Institution - 0149Mountain BrookAlabama35223-
Local Institution - 0212SacramentoCalifornia95815-
Local Institution - 0188WhittierCalifornia90602-
Local Institution - 0192SkokieIllinois60076-
Local Institution - 0203HopkinsvilleKentucky42240-
Local Institution - 0195Baton RougeLouisiana70836-
Local Institution - 0169CumberlandMaryland21502-
Local Institution - 0034OkemosMichigan48864-
Local Institution - 0133EaganMinnesota55121-
Local Institution - 0109HattiesburgMississippi39402-
Local Institution - 0108New YorkNew York10003-
Local Institution - 0186RochesterNew York14642-
Local Institution - 0196CharlotteNorth Carolina28277-
Local Institution - 0180ClevelandOhio44106-
Local Institution - 0189Oklahoma CityOklahoma73116-
Local Institution - 0147PortlandOregon97239-
Local Institution - 0016DuncansvillePennsylvania16635-
Local Institution - 0182SummervilleSouth Carolina29486-
Local Institution - 0167LubbockTexas79424-
Local Institution - 0070MesquiteTexas75150-
Local Institution - 0184PlanoTexas75024-
Local Institution - 0187SeattleWashington98122-
Local Institution - 0190FranklinWisconsin53132-
Local Institution - 0175MilwaukeeWisconsin53217-

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Find similar trials in Mountain Brook, AL

By condition
Psoriatic arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
Local Institution - 0149· Mountain Brook, ALLocal Institution - 0212· Sacramento, CALocal Institution - 0188· Whittier, CALocal Institution - 0192· Skokie, ILLocal Institution - 0203· Hopkinsville, KYLocal Institution - 0195· Baton Rouge, LA

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