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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Active Psoriatic Arthritis

Treatments: Other: BMS-986165 Placebo; Drug: BMS-986165 Dose B; Drug: Ustekinumab; Other: Ustekinumab Placebo; Drug: BMS-986165 Dose A

Study type: Interventional

Funder types: Industry

Identifiers

NCT03881059

IM011-084

2018-004293-10 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 6 patient groups, including a placebo group

Part A: Placebo

Placebo Comparator group

Treatment:

Other: BMS-986165 Placebo

Part A: BMS-986165 Dose A

Experimental group

Treatment:

Drug: BMS-986165 Dose A

Part A: BMS-986165 Dose B

Experimental group

Treatment:

Drug: BMS-986165 Dose B

Part B: Ustekinumab + BMS-986165 Placebo

Experimental group

Treatment:

Other: BMS-986165 Placebo

Drug: Ustekinumab

Part B: BMS-986165 Dose A + Ustekinumab Placebo

Experimental group

Treatment:

Drug: BMS-986165 Dose A

Other: Ustekinumab Placebo

Part B: BMS-986165 Dose B + Ustekinumab Placebo

Experimental group

Treatment:

Drug: BMS-986165 Dose B

Other: Ustekinumab Placebo