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

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ClinicalTrials.gov Identifier: NCT03881059
Recruitment Status : Not yet recruiting
First Posted : March 19, 2019
Last Update Posted : March 19, 2019
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).

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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)
Estimated Study Start Date : March 29, 2019
Estimated Primary Completion Date : April 20, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ustekinumab

Arm Intervention/treatment
Placebo Comparator: Part A: Placebo
Participants will receive BMS-986165 matching placebo as oral tablets once daily (QD) up to week 16.
Other: BMS-986165 Placebo
Participants will receive BMS-986165 matching placebo QD

Experimental: Part A: BMS-986165 Dose A QD
Participants will receive BMS-986165 dose A as oral tablets QD up to week 16.
Drug: BMS-986165 Dose A
Participants will receive BMS-986165 Dose A QD.

Experimental: Part A: BMS-986165 Dose B QD
Participants will receive BMS-986165 dose B as oral tablets QD up to week 16.
Drug: BMS-986165 Dose B
Participants will receive BMS-986165 dose B QD.

Experimental: Part B: Ustekinumab + BMS-986165 Placebo
Participants who received placebo, BMS-986165 Dose A and B QD and did not achieve MDA at Week 16 in case of BMS-986165 Dose A and B in Part A, will receive either 45 or 90 mg ustekinumab subcutaneous (SQ) injection based on body weight at Weeks 16, 20, 32 and 44 in Part B (Part B is optional for participants who completed Part A) plus placebo matching BMS-986165 QD (Week 16 to 52).
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
Participants who received BMS-986165 Dose A QD in Part A and achieved minimal disease activity (MDA) at Week 16, will receive BMS-986165 Dose A QD (Weeks 16-52) plus placebo matching ustekinumab SQ injection at Weeks 16, 20, 32 and 44 in Part B (Part B is optional for participants who completed Part A).
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
Participants who received BMS-986165 Dose B QD in Part A and achieved MDA at Week 16, will receive BMS-986165 Dose B QD (Weeks 16-52) plus placebo matching ustekinumab SQ injection at Weeks 16, 20, 32 and 44 in Part B (Part B is optional for participants who completed Part A).
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 ]
    ACR 20 refers to 20 percent (%), improvement over baseline in tender and swollen joint counts with standardized 68 and 66 joint count for swollen and tender joint counts respectively, and 20% improvement, in 3 of 5 following core data set measures: 1) participant global assessment of pain; 2) participant global assessment of disease activity; 3) physician global assessment of psoriatic arthritis; 4) participant assessment of physical function; 5) acute phase reactant value.


Secondary Outcome Measures :
  1. Change from Baseline in Health Assessment Questionnaire-disability Index (HAQ-DI) Score at Week 16 [ Time Frame: Baseline, Week 16 ]
    The HAQ-DI is a participant-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire the level of activity is cored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as much "difficulty", and 3 has "unable to do". Any activity that requires assistance from another individual or requires the use of an assistive device adjusts to a minimum score of 2 to represent a more limited functional status.

  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 ]
    The PASI is a measure of the average erythema, induration thickness and scaling of psoriatic skin lesions (each graded on a 0 to 4 scale), weighted by the area of involvement (head, arms, trunk to groin, and legs to top of buttocks). The PASI produces a numeric score that can range from 0 to 72, with higher PASI scores denoting more severe disease activity. The PASI can also be used to assess response to treatment. The PASI 75 is the proportion of participants who experience at least a 75 % improvement in PASI score as compared with the baseline value.

  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 ]
    The SF-36 is a participant-reported outcome measure in clinical practice and research. The instrument includes 36 items in a Likert-type format to measure the following 8 health dimensions over the past week: 1) limitations in physical activities, such as bathing or dressing; 2) limitations in social activities because of physical or emotional problems; 3) limitations in usual role activities because of physical health problems; 4) bodily pain; 5) general mental health (psychological distress and well-being); 6) limitations in usual role activities because of emotional problems; 7) vitality (energy and fatigue); and 8) general health perceptions. Scores for each domain range from 0 to 100, with high scores indicating a better status.



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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


Contacts
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Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #.

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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03881059     History of Changes
Other Study ID Numbers: IM011-084
2018-004293-10 ( EudraCT Number )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Arthritis
Arthritis, Psoriatic
Joint Diseases
Musculoskeletal Diseases
Spondylarthropathies
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Ustekinumab
Dermatologic Agents