Psoriasis Clinical Trial

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

Summary

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.

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Full Description

The study is intended to evaluate the safety and efficacy of BMS-986165 Dose A or B once daily (QD) compared with placebo in adults with active PsA. The primary endpoint is american college of rheumatology (ACR) 20 response at Week 16 (Part A).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Diagnosed with PsA for at least 6 months before screening, and who meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at screening
Participants either (i) cannot have prior exposure to biologics (biologic-naïve) or (ii) have failed or been intolerant to 1 tumor necrosis factor -inhibitor (TNFi) (TNFi-experienced). Failure is defined as lack of response or loss of response with at least 3 months of therapy with an approved dose of a TNFi, as judged by the investigator. Failure must have occurred at least 2 months prior to Day 1
Participants have at least 1 confirmed greater than or equal to (>=) 2 centimeter (cm) lesion of plaque psoriasis at screening
Participants have active arthritis as shown by a minimum of >= 3 swollen joints and >= 3 tender joints (66/68 joint counts) at screening and Day 1
High sensitivity C-reactive protein (hsCRP) >= 3milligram per liter (mg/L) at screening
Women of Childbearing Potential (WOCBP) must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment

Exclusion Criteria:

Has non-plaque psoriasis (that is (i.e.), guttate, inverse, pustular, erythrodermic or drug-induced psoriasis) at screening or Day 1
Has any other autoimmune condition such as rheumatoid arthritis, etc. There are exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed
Has active (i.e. currently symptomatic) fibromyalgia
History or evidence of active infection and/or febrile illness within 7 days prior to Day 1 (example, bronchopulmonary, urinary, gastrointestinal, etc.)
History of recent serious bacterial, fungal, or viral infections requiring hospitalization and intravenous (IV) antimicrobial treatment within 90 days prior to screening, or any infection requiring antimicrobial treatment within 15 days prior to Day 1
History of active tuberculosis (TB) prior to screening visit, regardless of completion of adequate treatment

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

203

Study ID:

NCT03881059

Recruitment Status:

Completed

Sponsor:

Bristol-Myers Squibb

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There are 92 Locations for this study

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Rheumatology Associates of North Alabama
Huntsville Alabama, 35801, United States
Medvin Clinical Research - Covina Office
Covina California, 91722, United States
University of California at San Diego Medical Center
La Jolla California, 92039, United States
Arthritis & Rheumatic Disease Specialties
Aventura Florida, 33180, United States
San Marcus Research Clinic
Miami Lakes Florida, 33014, United States
Omega Research Consultants - Metrowest
Orlando Florida, 32835, United States
Integral Rheumatology & Immunology Specialists
Plantation Florida, 33324, United States
BayCare Medical Group
Saint Petersburg Florida, 33705, United States
University of South Florida - Morsani College of Medicine
Tampa Florida, 33612, United States
Heartland Research Associates - East Wichita
Wichita Kansas, 67207, United States
Arthritis Center of Lexington
Lexington Kentucky, 40504, United States
Clinical Pharmacology Study Group
Worcester Massachusetts, 01605, United States
Arthritis Associates
Hattiesburg Mississippi, 39402, United States
Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Atlantic Coast Rheumatology
Toms River New Jersey, 08755, United States
Albuquerque Center for Rheumatology
Albuquerque New Mexico, 87102, United States
The Center for Rheumatology-Albany
Albany New York, 12203, United States
University of Rochester Medical Center
Rochester New York, 14642, United States
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte North Carolina, 28204, United States
DJL Clinical Research
Charlotte North Carolina, 28210, United States
PMG Research of Salisbury
Salisbury North Carolina, 28144, United States
Paramount Medical Research and Consulting
Middleburg Heights Ohio, 44130, United States
East Penn Rheumatology Associates
Bethlehem Pennsylvania, 18015, United States
Altoona Center for Clinical Research
Duncansville Pennsylvania, 16635, United States
Low Country Rheumatology
Summerville South Carolina, 29486, United States
West Tennessee Research Institute
Jackson Tennessee, 38305, United States
Office of Ramesh C. Gupta, MD
Memphis Tennessee, 38119, United States
Pioneer Research Solutions
Cypress Texas, 77429, United States
Southwest Rheumatology Research
Mesquite Texas, 75150, United States
Seattle Rheumatology Associates
Seattle Washington, 98122, United States
Arthritis Northwest Rheumatology
Spokane Washington, 99204, United States
L.K.N. Arthrocentrum, s.r.o
Hlu? , 748 0, Czechia
CCR Ostrava
Ostrava , 702 0, Czechia
Revmatologie MUDr. Klara Sirova s.r.o.
Ostrava , 702 0, Czechia
Arthrocentrum
Praha 10 , 101 0, Czechia
Affidea Praha
Praha 11 Chodov , 148 0, Czechia
CCR Prague
Praha 3 , 130 0, Czechia
Nuselska Poliklinika
Praha 4 , 140 0, Czechia
Revmatologicky Ustav
Praha , 128 0, Czechia
PV-Medical Services, s.r.o.
Zlin , 760 0, Czechia
Charite Universitatsmedizin Berlin
Berlin , 10117, Germany
Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
Berlin , 12161, Germany
Universitatsklinikum Erlangen
Erlangen , 91054, Germany
Universitatsklinikum Frankfurt
Frankfurt am Main , 60590, Germany
HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
Hamburg , 20095, Germany
SMO.MD GmbH
Magdeburg , 39120, Germany
Universitatsmedizin Mannheim
Mannheim , 68167, Germany
Klinikum der Universitat Munchen
Munchen , 80336, Germany
Clinexpert Gyogycentrum
Budapest , 1033, Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest , 1062, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen , 4032, Hungary
CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
Miskolc , 3529, Hungary
Aranyklinika
Szeged , 6720, Hungary
CMed Rehabilitacios es Diagnosztikai Kozpont
Szekesfehervar , 8000, Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes , 6600, Hungary
Azienda Ospedaliera Universitaria Integrata di Verona
Verona , 37134, Italy
Osteo-Medic
Bia?ystok , 15-35, Poland
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok , 15-07, Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok , 15-87, Poland
Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
Bydgoszcz , 85-06, Poland
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz , 85-16, Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag , 82-30, Poland
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Elblag , 82-30, Poland
Malopolskie Badania Kliniczne
Krakow , 30-00, Poland
Grazyna Pulka Specjalistyczny Osrodek All-med
Krak , 30-03, Poland
Pratia MCM Krakow
Krak , 30-51, Poland
AMED Centrum Medyczne
Lodz , 91-36, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna
Nadarzyn , 05-83, Poland
Centrum Badan Klinicznych S.C.
Poznan , 60-77, Poland
Ai Centrum Medyczne
Poznan , 61-11, Poland
Nasz Lekarz Przychodnie Medyczne
Torun , 87-10, Poland
Rheuma Medicus Zaklad Opieki Zdrowotnej
Warszawa , 02-11, Poland
Ars Rheumatica - Reumatika Centrum Reumatologii
Warszawa , 02-69, Poland
Centrum Medyczne AMED Warszawa Targowek
Warszawa , 03-29, Poland
WroMedica
Wroclaw , 51-68, Poland
Centrum Medyczne Oporow
Wroclaw , 52-41, Poland
Chelyabinsk Regional Clinical Hospital
Chelyabinsk , 45407, Russian Federation
Scientific Research Medical Complex
Kazan , 42009, Russian Federation
Medical Center Revma-Med
Kemerovo , 65007, Russian Federation
Clinic on Maroseyka
Moscow , 10100, Russian Federation
Medical Center Health Family
Novosibirsk , 63009, Russian Federation
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
Petrozavodsk , 18501, Russian Federation
Polyclinic of Private Security Personnel
Saint Petersburg , 19200, Russian Federation
Clinical Rheumatological Hospital Number 25
Saint-Petersburg , 19006, Russian Federation
LLC Medical Consultation and Research Center-Practice
Yarolavl , 15000, Russian Federation
Clinical Hospital named after NA Semashko
Yaroslavl , 15002, Russian Federation
Hospital Universitario Reina Sofia
Cordoba , 14004, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada , 28942, Spain
Hospital Universitario Ramon Y Cajal
Madrid , 28034, Spain
Corporacio Sanitaria Parc Tauli
Sabadell , 08208, Spain
Hospital Nuestra Senora de la Esperanza
Santiago de Compostela , 15705, Spain
Hospital Clinico Universitario de Valencia
Valencia , 46010, Spain
Bradford Teaching Hospitals NHS Foundation Trust
Bradford , BD5 0, United Kingdom
The Princess Alexandra Hospital NHS Trust
Harlow , CM20 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 2

Estimated Enrollment:

203

Study ID:

NCT03881059

Recruitment Status:

Completed

Sponsor:


Bristol-Myers Squibb

How clear is this clinincal trial information?

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