Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03881059
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : June 16, 2020
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

Brief 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.

Condition or disease Intervention/treatment Phase
Active Psoriatic Arthritis Other: BMS-986165 Placebo Drug: BMS-986165 Dose A Drug: BMS-986165 Dose B Drug: Ustekinumab Other: Ustekinumab Placebo Phase 2

Detailed 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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Investigative site staff, the Sponsor, and Participant will remain blinded to treatment assignment with the exception of an unblinded pharmacist, an unblinded study drug administrator (Part B), and an unblinded site monitor.
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-Controlled, Double-blind, Multicenter Study to Assess the Efficacy and Safety of Multiple Doses of BMS-986165 in Subjects With Active Psoriatic Arthritis (PsA)
Actual Study Start Date : March 28, 2019
Estimated Primary Completion Date : January 28, 2021
Estimated Study Completion Date : January 28, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Part A: Placebo Other: BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD

Experimental: Part A: BMS-986165 Dose A Drug: BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.

Experimental: Part A: BMS-986165 Dose B Drug: BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.

Experimental: Part B: Ustekinumab + BMS-986165 Placebo Other: BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD

Drug: Ustekinumab
Participants will receive ustekinumab SQ injection QD.

Experimental: Part B: BMS-986165 Dose A + Ustekinumab Placebo Drug: BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.

Other: Ustekinumab Placebo
Participants will receive ustekinumab SQ matching placebo QD

Experimental: Part B: BMS-986165 Dose B + Ustekinumab Placebo Drug: BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.

Other: Ustekinumab Placebo
Participants will receive ustekinumab SQ matching placebo QD




Primary Outcome Measures :
  1. Number of Participants Achieving American College of Rheumatology (ACR) 20 Response at Week 16 [ Time Frame: At Week 16 ]

Secondary Outcome Measures :
  1. Change from Baseline in Health Assessment Questionnaire-disability Index (HAQ-DI) Score at Week 16 [ Time Frame: Baseline, Week 16 ]
  2. Psoriasis Area and Severity Index (PASI) 75 response in Participants with at Least 3 Percent Body Surface Area (BSA) Involvement at Baseline [ Time Frame: At Week 16 ]
  3. Change from Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 Item (SF-36) Questionnaire at Week 16 [ Time Frame: Baseline, Week 16 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03881059


Locations
Show Show 92 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03881059    
Other Study ID Numbers: IM011-084
2018-004293-10 ( EudraCT Number )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: June 16, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
BMS-986165
Dermatologic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action