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.
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).
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exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed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
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There are 92 Locations for this study
Huntsville Alabama, 35801, United States
Covina California, 91722, United States
La Jolla California, 92039, United States
Aventura Florida, 33180, United States
Miami Lakes Florida, 33014, United States
Orlando Florida, 32835, United States
Plantation Florida, 33324, United States
Saint Petersburg Florida, 33705, United States
Tampa Florida, 33612, United States
Wichita Kansas, 67207, United States
Lexington Kentucky, 40504, United States
Worcester Massachusetts, 01605, United States
Hattiesburg Mississippi, 39402, United States
Lebanon New Hampshire, 03756, United States
Toms River New Jersey, 08755, United States
Albuquerque New Mexico, 87102, United States
Albany New York, 12203, United States
Rochester New York, 14642, United States
Charlotte North Carolina, 28204, United States
Charlotte North Carolina, 28210, United States
Salisbury North Carolina, 28144, United States
Middleburg Heights Ohio, 44130, United States
Bethlehem Pennsylvania, 18015, United States
Duncansville Pennsylvania, 16635, United States
Summerville South Carolina, 29486, United States
Jackson Tennessee, 38305, United States
Memphis Tennessee, 38119, United States
Cypress Texas, 77429, United States
Mesquite Texas, 75150, United States
Seattle Washington, 98122, United States
Spokane Washington, 99204, United States
Hlu? , 748 0, Czechia
Ostrava , 702 0, Czechia
Ostrava , 702 0, Czechia
Praha 10 , 101 0, Czechia
Praha 11 Chodov , 148 0, Czechia
Praha 3 , 130 0, Czechia
Praha 4 , 140 0, Czechia
Praha , 128 0, Czechia
Zlin , 760 0, Czechia
Berlin , 10117, Germany
Berlin , 12161, Germany
Erlangen , 91054, Germany
Frankfurt am Main , 60590, Germany
Hamburg , 20095, Germany
Magdeburg , 39120, Germany
Mannheim , 68167, Germany
Munchen , 80336, Germany
Budapest , 1033, Hungary
Budapest , 1062, Hungary
Debrecen , 4032, Hungary
Miskolc , 3529, Hungary
Szeged , 6720, Hungary
Szekesfehervar , 8000, Hungary
Szentes , 6600, Hungary
Verona , 37134, Italy
Bia?ystok , 15-35, Poland
Bialystok , 15-07, Poland
Bialystok , 15-87, Poland
Bydgoszcz , 85-06, Poland
Bydgoszcz , 85-16, Poland
Elblag , 82-30, Poland
Elblag , 82-30, Poland
Krakow , 30-00, Poland
Krak , 30-03, Poland
Krak , 30-51, Poland
Lodz , 91-36, Poland
Nadarzyn , 05-83, Poland
Poznan , 60-77, Poland
Poznan , 61-11, Poland
Torun , 87-10, Poland
Warszawa , 02-11, Poland
Warszawa , 02-69, Poland
Warszawa , 03-29, Poland
Wroclaw , 51-68, Poland
Wroclaw , 52-41, Poland
Chelyabinsk , 45407, Russian Federation
Kazan , 42009, Russian Federation
Kemerovo , 65007, Russian Federation
Moscow , 10100, Russian Federation
Novosibirsk , 63009, Russian Federation
Petrozavodsk , 18501, Russian Federation
Saint Petersburg , 19200, Russian Federation
Saint-Petersburg , 19006, Russian Federation
Yarolavl , 15000, Russian Federation
Yaroslavl , 15002, Russian Federation
Cordoba , 14004, Spain
Fuenlabrada , 28942, Spain
Madrid , 28034, Spain
Sabadell , 08208, Spain
Santiago de Compostela , 15705, Spain
Valencia , 46010, Spain
Bradford , BD5 0, United Kingdom
Harlow , CM20 , United Kingdom
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