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

Completed · Phase 2 · Has a placebo group

Conditions studied: Active Psoriatic Arthritis

In brief

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 facts

Study ID

NCT03881059

Run by

Bristol-Myers Squibb

People needed

203

Starts

2019-04-01

Expected to finish

2021-01-27

Last updated by the study team

2022-02-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed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

Where it is running

• Medvin Clinical Research - Covina Office — Covina, California, United States
• University of California at San Diego Medical Center — La Jolla, California, United States
• Arthritis & Rheumatic Disease Specialties — Aventura, Florida, United States
• San Marcus Research Clinic — Miami Lakes, Florida, United States
• Omega Research Consultants - Metrowest — Orlando, Florida, United States
• Integral Rheumatology & Immunology Specialists — Plantation, Florida, United States
• BayCare Medical Group — St. Petersburg, Florida, United States
• University of South Florida - Morsani College of Medicine — Tampa, Florida, United States
• Heartland Research Associates - East Wichita — Wichita, Kansas, United States
• Arthritis Center of Lexington — Lexington, Kentucky, United States
• Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
• Arthritis Associates — Hattiesburg, Mississippi, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Atlantic Coast Rheumatology — Toms River, New Jersey, United States
• Albuquerque Center for Rheumatology — Albuquerque, New Mexico, United States
• The Center for Rheumatology-Albany — Albany, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Joint Muscle Medical Care and Research Institute - Lilington Office — Charlotte, North Carolina, United States
• DJL Clinical Research — Charlotte, North Carolina, United States
• PMG Research of Salisbury — Salisbury, North Carolina, United States
• Paramount Medical Research and Consulting — Middleburg Heights, Ohio, United States
• East Penn Rheumatology Associates — Bethlehem, Pennsylvania, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Low Country Rheumatology — Summerville, South Carolina, United States
• Rheumatology Associates of North Alabama — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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