Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Bristol-Myers Squibb
Study ID
NCT03881059
Phase
PHASE2
Status
Completed

Conditions

  • Active Psoriatic Arthritis

Eligibility Criteria

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

Interventions

  • BMS-986165 Placebo — OTHER
    Participants will receive BMS-986165 matching placebo QD
  • BMS-986165 Dose A — DRUG
    Participants will receive BMS-986165 Dose A QD.
  • BMS-986165 Dose B — DRUG
    Participants will receive BMS-986165 dose B QD.
  • Ustekinumab — DRUG
    Participants will receive ustekinumab SQ injection QD.
  • Ustekinumab Placebo — OTHER
    Participants will receive ustekinumab SQ matching placebo QD

Study Details

The main purpose of study is to assess the dose-response relationship of BMS-986165 (Dose A or Dose B once daily \[QD\]) at Week 16 in the treatment of participants with active PsA.

Key Dates

Start date
Apr 1, 2019
Status verified
Jan 2022
Primary completion
Apr 27, 2020
Completion
Jan 27, 2021

Study Design

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

Arms

  • Placebo Comparator: Part A: Placebo
  • Experimental: Part A: BMS-986165 Dose A
  • Experimental: Part A: BMS-986165 Dose B
  • Experimental: Part B: Ustekinumab + BMS-986165 Placebo
  • Experimental: Part B: BMS-986165 Dose A + Ustekinumab Placebo
  • Experimental: Part B: BMS-986165 Dose B + Ustekinumab Placebo

Primary Outcome Measure

Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16 [ Time Frame: 16 weeks after first dose ]

Locations (31)

FacilityCityStateZIPSite coordinators
Rheumatology Associates of North AlabamaHuntsvilleAlabama35801-
Medvin Clinical Research - Covina OfficeCovinaCalifornia91722-
University of California at San Diego Medical CenterLa JollaCalifornia92039-
Arthritis & Rheumatic Disease SpecialtiesAventuraFlorida33180-
San Marcus Research ClinicMiami LakesFlorida33014-
Omega Research Consultants - MetrowestOrlandoFlorida32835-
Integral Rheumatology & Immunology SpecialistsPlantationFlorida33324-
BayCare Medical GroupSt. PetersburgFlorida33705-
University of South Florida - Morsani College of MedicineTampaFlorida33612-
Heartland Research Associates - East WichitaWichitaKansas67207-
Arthritis Center of LexingtonLexingtonKentucky40504-
Clinical Pharmacology Study GroupWorcesterMassachusetts01605-
Arthritis AssociatesHattiesburgMississippi39402-
Dartmouth-Hitchcock Medical CenterLebanonNew Hampshire03756-
Atlantic Coast RheumatologyToms RiverNew Jersey08755-
Albuquerque Center for RheumatologyAlbuquerqueNew Mexico87102-
The Center for Rheumatology-AlbanyAlbanyNew York12203-
University of Rochester Medical CenterRochesterNew York14642-
DJL Clinical ResearchCharlotteNorth Carolina28210-
Joint Muscle Medical Care and Research Institute - Lilington OfficeCharlotteNorth Carolina28204-
PMG Research of SalisburySalisburyNorth Carolina28144-
Paramount Medical Research and ConsultingMiddleburg HeightsOhio44130-
East Penn Rheumatology AssociatesBethlehemPennsylvania18015-
Altoona Center for Clinical ResearchDuncansvillePennsylvania16635-
Low Country RheumatologySummervilleSouth Carolina29486-
West Tennessee Research InstituteJacksonTennessee38305-
Office of Ramesh C. Gupta, MDMemphisTennessee38119-
Pioneer Research SolutionsCypressTexas77429-5890-
Southwest Rheumatology ResearchMesquiteTexas75150-
Seattle Rheumatology AssociatesSeattleWashington98122-
Arthritis Northwest RheumatologySpokaneWashington99204-

Find similar trials in Huntsville, AL

By research site
Rheumatology Associates of North Alabama· Huntsville, ALMedvin Clinical Research - Covina Office· Covina, CAUniversity of California at San Diego Medical Center· La Jolla, CAArthritis & Rheumatic Disease Specialties· Aventura, FLSan Marcus Research Clinic· Miami Lakes, FLOmega Research Consultants - Metrowest· Orlando, FL