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

• ClinicalTrials.gov Identifier: NCT03881059
• Recruitment Status: Completed
• First Posted: March 19, 2019
• Results First Posted: May 17, 2021
• Last Update Posted: February 15, 2022
• Sponsor: Bristol-Myers Squibb
• Information provided by (Responsible Party): Bristol-Myers Squibb

Study Description

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).

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 203 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: April 1, 2019
• Actual Primary Completion Date: April 27, 2020
• Actual Study Completion Date: January 27, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16 [ Time Frame: 16 weeks after first dose ]
   A participant is considered an ACR 20 responder if the following three conditions are met: 1) ≥ 20% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 20% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 20% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)

Secondary Outcome Measures :

1. Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
   The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person has experienced during the past week in 8 domains of daily living activities. Each activity category consists of 2 to 3 questions (total of 20 questions). For reach question the level of activity is scored from 0 to 3, with 0 representing "no difficulty" and 3 as "unable to do". Any activity that requires assistance from another individual or an assistive device adjusts to a minimum score of 2. For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
2. Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response [ Time Frame: 16 weeks after first dose ]
   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 75 response rate represents the percentage of participants who experienced at least a 75% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
3. Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
   The SF-36 is a patient-reported outcome measure, which 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. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
4. Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16 [ Time Frame: 16 weeks after first dose ]
   A participant is considered an ACR 50 responder if the following three conditions are met: 1) ≥ 50% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 50% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 50% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
5. Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16 [ Time Frame: 16 weeks after first dose ]
   A participant is considered an ACR 70 responder if the following three conditions are met: 1) ≥ 70% improvement from baseline in the number of tender joints (68 joint count). 2) ≥ 70% improvement from baseline in the number of swollen joints (66 joint count). 3) ≥ 70% improvement from baseline in at least 3 of the following 5 domains: o Subject Global Assessment of disease activity o Physician Global Assessment of psoriatic arthritis o Subject Global Assessment of pain o Health Assessment Questionnaire-Disability Index (HAQ-DI) o High-sensitivity C-reactive protein (hsCRP)
6. Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) [ Time Frame: 16 weeks after first dose ]
   A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • > 5.1: High disease activity. Only participants with a score < 3.2 are considered to have achieved low disease activity.
7. Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) [ Time Frame: 16 weeks after first dose ]
   A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • > 5.1: High disease activity. Only participants with a score < 2.6 are considered to have achieved remission.
8. Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
   A Disease Activity Score (DAS) is a scoring system used to assess disease activity. DAS 28 CRP is a composite outcome measure that assesses: • How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints, but excluding distal interphalangeal joints), wrists, elbows, shoulders, and knees are swollen and/or tender over a total of 28. • C Reactive Protein (CRP) levels in the blood (as a measure of the degree of inflammation) • Subject Global Assessment of disease activity The results are combined to produce the DAS 28 CRP score, which correlates with the extent of disease activity as follows: • < 2.6: Disease remission • 2.6 - 3.2: Low disease activity • 3.2 - 5.1: Moderate disease activity • > 5.1: High disease activity. Adjusted change represents a change from baseline based on statistical model.
9. Adjusted Change From Baseline in Dactylitis Count [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
   The number of digits in hands and feet with dactylitis (Tender + Non-Tender) was counted and change from baseline at week 16 was assessed. Adjusted change represents a change from baseline based on statistical model.
10. Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    The Leeds Dactylitis Index (LDI) Basic is a quantitative measurement of dactylitis in the 20 digits using a dactylometer. The circumference of the affected and contralateral digits, and tenderness of the affected digits are measured to generate a total score. For each dactylitic digit, the final score is defined as: [{(A/B) - 1}*100]*C, where A is circumference of involved digit, B is circumference of the opposite, unaffected, digit or reference, and C is tenderness (0 or 1). The total score is determined by summing the relative score of all digits. A higher score indicates worse dactylitis. Adjusted change represents a change from baseline based on statistical model.
11. Percentage of Participants Achieving Dactylitis Resolution [ Time Frame: 16 weeks after first dose ]
    Dactylitis resolution (tender digits only) is defined as a dactylitis count of 0 in participants with dactylitis count ≥ 1 at baseline
12. Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI) [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Adjusted change represents a change from baseline based on statistical model.
13. Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Adjusted change represents a change from baseline based on statistical model.
14. Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI) [ Time Frame: 16 weeks after first dose ]
    The LEI was developed specifically for psoriatic arthritis. An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 entheseal sites (right and left: lateral epicondyle, medial femoral condyle, and Achilles tendon insertion) at the time of evaluation. A higher count indicates a greater enthesitis burden. Enthesitis resolution is defined as s LEI score of 0, in subjects with LEI ≥ 1 at baseline
15. Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index [ Time Frame: 16 weeks after first dose ]
    The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (R/L), quadriceps tendon insertion into the patella (R/L), patellar ligament insertion into the patella and tibial tuberosity (R/L), Achilles tendon insertion (R/L), plantar fascia insertion (R/L), medial and lateral epicondyles (R/L), and the supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation. Enthesitis resolution defined as a SPARCC enthesitis index score of 0, in subjects with SPARCC ≥ 1 at baseline.
16. Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1 [ Time Frame: 16 weeks after first dose ]
    In participants with psoriasis fingernail involvement, the PGA-F score is used to evaluate the overall condition of the fingernails in terms of disease severity. The assessment is performed by the investigator, who rates the fingernail condition on a 5-point scale based on the higher of the nail bed/nail matrix score. Scores are 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe).
17. Percentage of Participants Achieving Minimal Disease Activity (MDA) Response [ Time Frame: 16 weeks after first dose ]
    A Minimal Disease Activity (MDA) responder is defined as a participant fulfilling 5 of the following 7 outcomes: • Tender joint count ≤ 1 • Swollen joint count ≤ 1 • Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% • Subject Global Assessment of pain ≤ 15 • Subject Global Assessment of disease activity ≤ 20 • Health Assessment Questionnaire-Disability Index (HAQ-DI) ≤ 0.5 • Tender entheseal points ≤ 1
18. Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS) [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    PASDAS is a composite measure calculated from the Physician Global Assessment of psoriatic arthritis, the Subject Global Assessment of disease activity, the Short Form Health Survey-36 Item (SF-36) Physical Component Summary (PCS), the swollen joint count, the tender joint count, the Leeds Enthesitis Index (LEI), the Leeds Dactylitis Index (LDI) (Basic), and the the levels of high-sensitivity C-reactive Protein (hsCRP). Each item contributes differently to the final score, which ranges from 0 to 10 (higher scores represent a higher level of disease activity). Adjusted change represents a change from baseline based on statistical model.
19. Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA) [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    DAPSA is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender/painful joint count 68, swollen joint count 66, Subject Global Assessment of disease activity, Subject Global Assessment of pain, and the levels of C-reactive Protein (CRP). Final scores are interpreted as follows: - ≤4 = Remission (REM) - > 4 and ≤ 28 = moderate disease activity (MDA) - >28 = high disease activity (HDA). Adjusted change represents a change from baseline based on statistical model.
20. Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC) [ Time Frame: 16 weeks after first dose ]
    PsARC consists of 4 measurements: tender/painful joint count, swollen joint count, Physician Global Assessment of psoriatic arthritis, and Subject Global Assessment of pain ≤ 15. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, one of which must be joint pain or swelling, without worsening in any measure.
21. Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
    In participants with baseline evidence of Psoriatic Arthritis Spondylitis, symptoms are evaluated using the BASDAI, which consists of a 0 to 100 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: • Fatigue (medical) • Spinal pain • Joint pain and swelling • Areas of localized tenderness • Morning stiffness duration • Morning stiffness severity A higher count indicates worse disease. Adjusted change represents a change from baseline based on statistical model.
22. Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
    The SF-36 is a patient-reported outcome measure, which 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. The 8 health dimensions assessed are grouped into 2 main components, physical and mental. Each of the 8 dimensions contribute to both the Physical Component Summary (PCS) score and the Mental Component Summary (MCS) score. PCS and MCS scores range from 0 to 100, with high scores indicating a better health status. Adjusted change represents a change from baseline based on statistical model.
23. Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
    PsAID is a 12-item self-report that measures psoriatic arthritis symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale, and each item contributes differently to the final score. Weighted scores for each item are summed and divided by 20 to generate the final score, ranging from 0 to 10 (higher values indicate worse health). Adjusted change represents a change from baseline based on statistical model.
24. Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
    The FACIT-Fatigue instrument is a questionnaire used to evaluate a range of self-reported symptoms over the past week, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The questionnaire is composed of 13 questions (Short Form 13a) and each question is scored from 1 to 5. The final score results from the sum of the scores of the 13 questions, and ranges from 13 (most desirable outcome) to 65 (least desirable outcome). Adjusted change represents a change from baseline based on statistical model.
25. Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score [ Time Frame: From baseline (day of the first dose) to 16 weeks after first dose ]
    The Work Limitation Questionnaire (WLQ) is a 25-item self-report that measures the on-the-job impact of chronic health conditions and treatment over the past 2 weeks. It focuses on assessing limitations while performing specific job demands from the following 4 domains: 1) Time management: difficulty with handling time and scheduling demands (5 items) 2) Physical demands: ability to perform job tasks that involve bodily strength, movement, endurance, coordination, and flexibility (6 items) 3) Mental-interpersonal demands: cognitively demanding tasks and on-the-job social interactions (9 items) 4) Output demands: concerns reduced work productivity (5 items). Final score ranges from 0 (limited none of the time) to 100 (limited all of the time). The score can be used to calculate a percent of lost work productivity due to a particular disease state. Adjusted change represents a change from baseline based on statistical model.
26. Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response [ Time Frame: 16 weeks after first dose ]
    The HAQ-DI is measured by the use of a patient-reported outcome measure questionnaire, assessing the degree of difficulty a person 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 questions (total of 20 questions). For reach question the level of activity is scored from 0 ("no difficulty") to 3 ("unable to do"). For each activity category, the highest score reported in the 2 or 3 questions pertinent to that category represents the category score. Scores from the 8 categories are then summed and divided by 8 to generate the final score. The final score can range from 0 (most desirable outcome) to 3 (least desirable outcome). A HAQ-DI 0.35 responder is defined as a participant with an improvement from baseline in HAQ-DI score of at least 0.35.
27. Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response [ Time Frame: 16 weeks after first dose ]
    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 90 response rate represents the percentage of participants who experienced at least a 90% improvement in PASI score as compared with the baseline value. PASI assessment was performed by trained professionals.
28. Change From Baseline in Electrocardiogram (ECG) Results [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
29. Change From Baseline in Electrocardiogram (ECG) Heart Rate [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
30. Change From Baseline in Vital Signs - Diastolic Blood Pressure [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
31. Change From Baseline in Vital Signs - Heart Rate [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
32. Change From Baseline in Vital Signs - Respiratory Rate [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
33. Change From Baseline in Vital Signs - Systolic Blood Pressure [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
34. Change From Baseline in Vital Signs - Temperature [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]
35. Change From Baseline in Vital Signs - Weight [ Time Frame: From baseline (day of first dose) to 16 weeks after first dose ]

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Alabama

Rheumatology Associates of North Alabama

Huntsville, Alabama, United States, 35801

United States, California

Medvin Clinical Research - Covina Office

Covina, California, United States, 91722

University of California at San Diego Medical Center

La Jolla, California, United States, 92039

United States, Florida

Arthritis & Rheumatic Disease Specialties

Aventura, Florida, United States, 33180

San Marcus Research Clinic

Miami Lakes, Florida, United States, 33014

Omega Research Consultants - Metrowest

Orlando, Florida, United States, 32835

Integral Rheumatology & Immunology Specialists

Plantation, Florida, United States, 33324

BayCare Medical Group

Saint Petersburg, Florida, United States, 33705

University of South Florida - Morsani College of Medicine

Tampa, Florida, United States, 33612

United States, Kansas

Heartland Research Associates - East Wichita

Wichita, Kansas, United States, 67207

United States, Kentucky

Arthritis Center of Lexington

Lexington, Kentucky, United States, 40504

United States, Massachusetts

Clinical Pharmacology Study Group

Worcester, Massachusetts, United States, 01605

United States, Mississippi

Arthritis Associates

Hattiesburg, Mississippi, United States, 39402

United States, New Hampshire

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New Jersey

Atlantic Coast Rheumatology

Toms River, New Jersey, United States, 08755

United States, New Mexico

Albuquerque Center for Rheumatology

Albuquerque, New Mexico, United States, 87102

United States, New York

The Center for Rheumatology-Albany

Albany, New York, United States, 12203

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, North Carolina

Joint Muscle Medical Care and Research Institute - Lilington Office

Charlotte, North Carolina, United States, 28204

DJL Clinical Research

Charlotte, North Carolina, United States, 28210

PMG Research of Salisbury

Salisbury, North Carolina, United States, 28144

United States, Ohio

Paramount Medical Research and Consulting

Middleburg Heights, Ohio, United States, 44130

United States, Pennsylvania

East Penn Rheumatology Associates

Bethlehem, Pennsylvania, United States, 18015

Altoona Center for Clinical Research

Duncansville, Pennsylvania, United States, 16635

United States, South Carolina

Low Country Rheumatology

Summerville, South Carolina, United States, 29486

United States, Tennessee

West Tennessee Research Institute

Jackson, Tennessee, United States, 38305

Office of Ramesh C. Gupta, MD

Memphis, Tennessee, United States, 38119

United States, Texas

Pioneer Research Solutions

Cypress, Texas, United States, 77429-5890

Southwest Rheumatology Research

Mesquite, Texas, United States, 75150

United States, Washington

Seattle Rheumatology Associates

Seattle, Washington, United States, 98122

Arthritis Northwest Rheumatology

Spokane, Washington, United States, 99204

Czechia

L.K.N. Arthrocentrum, s.r.o

Hlu?, Czechia, 748 01

CCR Ostrava

Ostrava, Czechia, 702 00

Revmatologie MUDr. Klara Sirova s.r.o.

Ostrava, Czechia, 702 00

Arthrocentrum

Praha 10, Czechia, 101 00

Affidea Praha

Praha 11 Chodov, Czechia, 148 00

CCR Prague

Praha 3, Czechia, 130 00

Nuselska Poliklinika

Praha 4, Czechia, 140 00

Revmatologicky Ustav

Praha, Czechia, 128 00

PV-Medical Services, s.r.o.

Zlin, Czechia, 760 01

Germany

Charite Universitatsmedizin Berlin

Berlin, Germany, 10117

Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens

Berlin, Germany, 12161

Universitatsklinikum Erlangen

Erlangen, Germany, 91054

Universitatsklinikum Frankfurt

Frankfurt am Main, Germany, 60590

HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg

Hamburg, Germany, 20095

SMO.MD GmbH

Magdeburg, Germany, 39120

Universitatsmedizin Mannheim

Mannheim, Germany, 68167

Klinikum der Universitat Munchen

Munchen, Germany, 80336

Hungary

Clinexpert Gyogycentrum

Budapest, Hungary, 1033

Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, Hungary, 1062

Debreceni Egyetem Klinikai Kozpont

Debrecen, Hungary, 4032

CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag

Miskolc, Hungary, 3529

Aranyklinika

Szeged, Hungary, 6720

CMed Rehabilitacios es Diagnosztikai Kozpont

Szekesfehervar, Hungary, 8000

Csongrad Megyei Dr. Bugyi Istvan Korhaz

Szentes, Hungary, 6600

Italy

Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy, 37134

Poland

Osteo-Medic

Bia?ystok, Poland, 15-351

Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk

Bialystok, Poland, 15-077

ClinicMed Daniluk Nowak Spolka Jawna

Bialystok, Poland, 15-879

Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz

Bydgoszcz, Poland, 85-068

Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy

Bydgoszcz, Poland, 85-168

Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska

Elblag, Poland, 82-300

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela

Elblag, Poland, 82-300

Malopolskie Badania Kliniczne

Krakow, Poland, 30-002

Grazyna Pulka Specjalistyczny Osrodek All-med

Krak, Poland, 30-033

Pratia MCM Krakow

Krak, Poland, 30-510

AMED Centrum Medyczne

Lodz, Poland, 91-363

Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna

Nadarzyn, Poland, 05-830

Centrum Badan Klinicznych S.C.

Poznan, Poland, 60-773

Ai Centrum Medyczne

Poznan, Poland, 61-113

Nasz Lekarz Przychodnie Medyczne

Torun, Poland, 87-100

Rheuma Medicus Zaklad Opieki Zdrowotnej

Warszawa, Poland, 02-118

Ars Rheumatica - Reumatika Centrum Reumatologii

Warszawa, Poland, 02-691

Centrum Medyczne AMED Warszawa Targowek

Warszawa, Poland, 03-291

WroMedica

Wroclaw, Poland, 51-685

Centrum Medyczne Oporow

Wroclaw, Poland, 52-416

Russian Federation

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, Russian Federation, 454076

Scientific Research Medical Complex

Kazan, Russian Federation, 420097

Medical Center Revma-Med

Kemerovo, Russian Federation, 650070

Clinic on Maroseyka

Moscow, Russian Federation, 101000

Medical Center Health Family

Novosibirsk, Russian Federation, 630099

State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova

Petrozavodsk, Russian Federation, 185019

Polyclinic of Private Security Personnel

Saint Petersburg, Russian Federation, 192007

Clinical Rheumatological Hospital Number 25

Saint-Petersburg, Russian Federation, 190068

LLC Medical Consultation and Research Center-Practice

Yarolavl, Russian Federation, 150003

Clinical Hospital named after NA Semashko

Yaroslavl, Russian Federation, 150023

Spain

Hospital Universitario Reina Sofia

Cordoba, Spain, 14004

Hospital Universitario de Fuenlabrada

Fuenlabrada, Spain, 28942

Hospital Universitario Ramon Y Cajal

Madrid, Spain, 28034

Corporacio Sanitaria Parc Tauli

Sabadell, Spain, 08208

Hospital Nuestra Senora de la Esperanza

Santiago de Compostela, Spain, 15705

Hospital Clinico Universitario de Valencia

Valencia, Spain, 46010

United Kingdom

Bradford Teaching Hospitals NHS Foundation Trust

Bradford, United Kingdom, BD5 0NA

The Princess Alexandra Hospital NHS Trust

Harlow, United Kingdom, CM20 1QX

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb; Bristol-Myers Squibb

  Study Documents (Full-Text)

Documents provided by Bristol-Myers Squibb:

Study Protocol  [PDF] September 23, 2019

Statistical Analysis Plan  [PDF] June 5, 2020

More Information

Additional Information:

BMS Clinical Trial Information 

BMS Clinical Trial Patient Recruiting 

FDA Safety Alerts and Recalls 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mease PJ, Deodhar AA, van der Heijde D, Behrens F, Kivitz AJ, Neal J, Kim J, Singhal S, Nowak M, Banerjee S. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis. Ann Rheum Dis. 2022 Jun;81(6):815-822. doi: 10.1136/annrheumdis-2021-221664. Epub 2022 Mar 3.

• 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
• Results First Posted: May 17, 2021
• Last Update Posted: February 15, 2022
• Last Verified: January 2022

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

Additional relevant 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