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Recruiting

Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) - IM011-084

Updated: 10 June, 2019   |   ClinicalTrials.gov

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CONSIDERING THIS TRIAL?
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Use the Study Participants Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 2

    Phase

  • Gender(s)

  • 18+

    Age Range

  • 81

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Part A: BMS-986165 Dose A
Drug: BMS-986165 Dose A
Experimental: Part A: BMS-986165 Dose B
Drug: BMS-986165 Dose B
Placebo Comparator: Part A: Placebo
Other: BMS-986165 Placebo
Experimental: Part B: BMS-986165 Dose A + Ustekinumab Placebo
Drug: BMS-986165 Dose A Other: Ustekinumab Placebo
Experimental: Part B: BMS-986165 Dose B + Ustekinumab Placebo
Drug: BMS-986165 Dose B Other: Ustekinumab Placebo
Experimental: Part B: Ustekinumab + BMS-986165 Placebo
Other: BMS-986165 Placebo Drug: Ustekinumab

Key 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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Have questions? Live support is available 24/7 -
Call 855-907-3286 or Email Us