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

Primary Purpose

Active Psoriatic Arthritis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BMS-986165 Placebo
BMS-986165 Dose A
BMS-986165 Dose B
Ustekinumab
Ustekinumab Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active Psoriatic Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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exceptions for inflammatory bowel disease or uveitis as follows: currently active disease is excluded but, a history of no longer active disease for at least 12 months (including not being on medication) is allowed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

Sites / Locations

  • Rheumatology Associates of North Alabama
  • Medvin Clinical Research - Covina Office
  • University of California at San Diego Medical Center
  • Arthritis & Rheumatic Disease Specialties
  • San Marcus Research Clinic
  • Omega Research Consultants - Metrowest
  • Integral Rheumatology & Immunology Specialists
  • BayCare Medical Group
  • University of South Florida - Morsani College of Medicine
  • Heartland Research Associates - East Wichita
  • Arthritis Center of Lexington
  • Clinical Pharmacology Study Group
  • Arthritis Associates
  • Dartmouth-Hitchcock Medical Center
  • Atlantic Coast Rheumatology
  • Albuquerque Center for Rheumatology
  • The Center for Rheumatology-Albany
  • University of Rochester Medical Center
  • Joint Muscle Medical Care and Research Institute - Lilington Office
  • DJL Clinical Research
  • PMG Research of Salisbury
  • Paramount Medical Research and Consulting
  • East Penn Rheumatology Associates
  • Altoona Center for Clinical Research
  • Low Country Rheumatology
  • West Tennessee Research Institute
  • Office of Ramesh C. Gupta, MD
  • Pioneer Research Solutions
  • Southwest Rheumatology Research
  • Seattle Rheumatology Associates
  • Arthritis Northwest Rheumatology
  • L.K.N. Arthrocentrum, s.r.o
  • CCR Ostrava
  • Revmatologie MUDr. Klara Sirova s.r.o.
  • Arthrocentrum
  • Affidea Praha
  • CCR Prague
  • Nuselska Poliklinika
  • Revmatologicky Ustav
  • PV-Medical Services, s.r.o.
  • Charite Universitatsmedizin Berlin
  • Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
  • Universitatsklinikum Erlangen
  • Universitatsklinikum Frankfurt
  • HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
  • SMO.MD GmbH
  • Universitatsmedizin Mannheim
  • Klinikum der Universitat Munchen
  • Clinexpert Gyogycentrum
  • Magyar Honvedseg Egeszsegugyi Kozpont
  • Debreceni Egyetem Klinikai Kozpont
  • CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
  • Aranyklinika
  • CMed Rehabilitacios es Diagnosztikai Kozpont
  • Csongrad Megyei Dr. Bugyi Istvan Korhaz
  • Azienda Ospedaliera Universitaria Integrata di Verona
  • Osteo-Medic
  • Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
  • ClinicMed Daniluk Nowak Spolka Jawna
  • Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
  • Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
  • Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
  • Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
  • Malopolskie Badania Kliniczne
  • Grazyna Pulka Specjalistyczny Osrodek All-med
  • Pratia MCM Krakow
  • AMED Centrum Medyczne
  • Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna
  • Centrum Badan Klinicznych S.C.
  • Ai Centrum Medyczne
  • Nasz Lekarz Przychodnie Medyczne
  • Rheuma Medicus Zaklad Opieki Zdrowotnej
  • Ars Rheumatica - Reumatika Centrum Reumatologii
  • Centrum Medyczne AMED Warszawa Targowek
  • WroMedica
  • Centrum Medyczne Oporow
  • Chelyabinsk Regional Clinical Hospital
  • Scientific Research Medical Complex
  • Medical Center Revma-Med
  • Clinic on Maroseyka
  • Medical Center Health Family
  • State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
  • Polyclinic of Private Security Personnel
  • Clinical Rheumatological Hospital Number 25
  • LLC Medical Consultation and Research Center-Practice
  • Clinical Hospital named after NA Semashko
  • Hospital Universitario Reina Sofia
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitario Ramon Y Cajal
  • Corporacio Sanitaria Parc Tauli
  • Hospital Nuestra Senora de la Esperanza
  • Hospital Clinico Universitario de Valencia
  • Bradford Teaching Hospitals NHS Foundation Trust
  • The Princess Alexandra Hospital NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Part A: Placebo

Part A: BMS-986165 Dose A

Part A: BMS-986165 Dose B

Part B: Ustekinumab + BMS-986165 Placebo

Part B: BMS-986165 Dose A + Ustekinumab Placebo

Part B: BMS-986165 Dose B + Ustekinumab Placebo

Arm Description

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
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

Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
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.
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response
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.
Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
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.
Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16
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)
Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16
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)
Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
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.
Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
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.
Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score
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.
Adjusted Change From Baseline in Dactylitis Count
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.
Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score
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.
Percentage of Participants Achieving Dactylitis Resolution
Dactylitis resolution (tender digits only) is defined as a dactylitis count of 0 in participants with dactylitis count ≥ 1 at baseline
Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)
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.
Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
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.
Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)
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
Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
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.
Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1
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).
Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
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
Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
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.
Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)
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.
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
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.
Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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.
Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
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.
Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
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.
Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
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.
Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score
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.
Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response
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.
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response
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.
Change From Baseline in Electrocardiogram (ECG) Results
Change From Baseline in Electrocardiogram (ECG) Heart Rate
Change From Baseline in Vital Signs - Diastolic Blood Pressure
Change From Baseline in Vital Signs - Heart Rate
Change From Baseline in Vital Signs - Respiratory Rate
Change From Baseline in Vital Signs - Systolic Blood Pressure
Change From Baseline in Vital Signs - Temperature
Change From Baseline in Vital Signs - Weight

Full Information

First Posted
March 18, 2019
Last Updated
January 25, 2022
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT03881059
Brief Title
Efficacy and Safety of BMS-986165 Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
April 27, 2020 (Actual)
Study Completion Date
January 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active Psoriatic Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
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.
Allocation
Randomized
Enrollment
203 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Part A: Placebo
Arm Type
Placebo Comparator
Arm Title
Part A: BMS-986165 Dose A
Arm Type
Experimental
Arm Title
Part A: BMS-986165 Dose B
Arm Type
Experimental
Arm Title
Part B: Ustekinumab + BMS-986165 Placebo
Arm Type
Experimental
Arm Title
Part B: BMS-986165 Dose A + Ustekinumab Placebo
Arm Type
Experimental
Arm Title
Part B: BMS-986165 Dose B + Ustekinumab Placebo
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
BMS-986165 Placebo
Intervention Description
Participants will receive BMS-986165 matching placebo QD
Intervention Type
Drug
Intervention Name(s)
BMS-986165 Dose A
Intervention Description
Participants will receive BMS-986165 Dose A QD.
Intervention Type
Drug
Intervention Name(s)
BMS-986165 Dose B
Intervention Description
Participants will receive BMS-986165 dose B QD.
Intervention Type
Drug
Intervention Name(s)
Ustekinumab
Intervention Description
Participants will receive ustekinumab SQ injection QD.
Intervention Type
Other
Intervention Name(s)
Ustekinumab Placebo
Intervention Description
Participants will receive ustekinumab SQ matching placebo QD
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving the American College of Rheumatology (ACR) 20 Response at Week 16
Description
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)
Time Frame
16 weeks after first dose
Secondary Outcome Measure Information:
Title
Adjusted Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI)
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 75 Response
Description
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.
Time Frame
16 weeks after first dose
Title
Adjusted Change From Baseline in the Physical Component Summary (PCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving the American College of Rheumatology (ACR) 50 Response at Week 16
Description
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)
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving the American College of Rheumatology (ACR) 70 Response at Week 16
Description
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)
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving Low Disease Activity According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
Description
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.
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving Remission According to the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP)
Description
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.
Time Frame
16 weeks after first dose
Title
Adjusted Change From Baseline in the Disease Activity Score-28 Using C Reactive Protein (DAS 28 CRP) Score
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in Dactylitis Count
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Leeds Dactylitis Index (LDI) Basic Score
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving Dactylitis Resolution
Description
Dactylitis resolution (tender digits only) is defined as a dactylitis count of 0 in participants with dactylitis count ≥ 1 at baseline
Time Frame
16 weeks after first dose
Title
Adjusted Change From Baseline in Enthesitis by the Leeds Enthesitis Index (LEI)
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in Enthesitis by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving Enthesitis Resolution by the Leeds Enthesitis Index (LEI)
Description
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
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving Enthesitis Resolution by the Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
Description
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.
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving a Physicians Global Assessment-Fingernails (PGA-F) Score of 0 or 1
Description
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).
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving Minimal Disease Activity (MDA) Response
Description
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
Time Frame
16 weeks after first dose
Title
Adjusted Change From Baseline in the Psoriatic Arthritis Disease Activity Score (PASDAS)
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Disease Activity Index for Psoriatic Arthritis Score (DAPSA)
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving Psoriatic Arthritis Response Criteria (PsARC)
Description
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.
Time Frame
16 weeks after first dose
Title
Adjusted Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Description
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.
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Mental Component Summary (MCS) Score of the Short Form Health Survey-36 (SF-36) Questionnaire
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) Score
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Adjusted Change From Baseline in the Work Limitation Questionnaire (WLQ) Score
Description
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.
Time Frame
From baseline (day of the first dose) to 16 weeks after first dose
Title
Percentage of Participants Achieving Health Assessment Questionnaire-Disability Index (HAQ-DI) 0.35 Response
Description
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.
Time Frame
16 weeks after first dose
Title
Percentage of Participants Achieving the Psoriasis Area and Severity Index (PASI) 90 Response
Description
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.
Time Frame
16 weeks after first dose
Title
Change From Baseline in Electrocardiogram (ECG) Results
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Electrocardiogram (ECG) Heart Rate
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Diastolic Blood Pressure
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Heart Rate
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Respiratory Rate
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Systolic Blood Pressure
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Temperature
Time Frame
From baseline (day of first dose) to 16 weeks after first dose
Title
Change From Baseline in Vital Signs - Weight
Time Frame
From baseline (day of first dose) to 16 weeks after first dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Medvin Clinical Research - Covina Office
City
Covina
State/Province
California
ZIP/Postal Code
91722
Country
United States
Facility Name
University of California at San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92039
Country
United States
Facility Name
Arthritis & Rheumatic Disease Specialties
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Omega Research Consultants - Metrowest
City
Orlando
State/Province
Florida
ZIP/Postal Code
32835
Country
United States
Facility Name
Integral Rheumatology & Immunology Specialists
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
BayCare Medical Group
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33705
Country
United States
Facility Name
University of South Florida - Morsani College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Heartland Research Associates - East Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Arthritis Center of Lexington
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40504
Country
United States
Facility Name
Clinical Pharmacology Study Group
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01605
Country
United States
Facility Name
Arthritis Associates
City
Hattiesburg
State/Province
Mississippi
ZIP/Postal Code
39402
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Atlantic Coast Rheumatology
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
Albuquerque Center for Rheumatology
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
The Center for Rheumatology-Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12203
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Joint Muscle Medical Care and Research Institute - Lilington Office
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
DJL Clinical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
PMG Research of Salisbury
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Paramount Medical Research and Consulting
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
East Penn Rheumatology Associates
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Low Country Rheumatology
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29486
Country
United States
Facility Name
West Tennessee Research Institute
City
Jackson
State/Province
Tennessee
ZIP/Postal Code
38305
Country
United States
Facility Name
Office of Ramesh C. Gupta, MD
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Pioneer Research Solutions
City
Cypress
State/Province
Texas
ZIP/Postal Code
77429-5890
Country
United States
Facility Name
Southwest Rheumatology Research
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Seattle Rheumatology Associates
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Arthritis Northwest Rheumatology
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
L.K.N. Arthrocentrum, s.r.o
City
Hlu?
ZIP/Postal Code
748 01
Country
Czechia
Facility Name
CCR Ostrava
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Revmatologie MUDr. Klara Sirova s.r.o.
City
Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
Arthrocentrum
City
Praha 10
ZIP/Postal Code
101 00
Country
Czechia
Facility Name
Affidea Praha
City
Praha 11 Chodov
ZIP/Postal Code
148 00
Country
Czechia
Facility Name
CCR Prague
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
Nuselska Poliklinika
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
Revmatologicky Ustav
City
Praha
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
PV-Medical Services, s.r.o.
City
Zlin
ZIP/Postal Code
760 01
Country
Czechia
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
City
Berlin
ZIP/Postal Code
12161
Country
Germany
Facility Name
Universitatsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitatsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Facility Name
HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
City
Hamburg
ZIP/Postal Code
20095
Country
Germany
Facility Name
SMO.MD GmbH
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitatsmedizin Mannheim
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Klinikum der Universitat Munchen
City
Munchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Clinexpert Gyogycentrum
City
Budapest
ZIP/Postal Code
1033
Country
Hungary
Facility Name
Magyar Honvedseg Egeszsegugyi Kozpont
City
Budapest
ZIP/Postal Code
1062
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
City
Miskolc
ZIP/Postal Code
3529
Country
Hungary
Facility Name
Aranyklinika
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
CMed Rehabilitacios es Diagnosztikai Kozpont
City
Szekesfehervar
ZIP/Postal Code
8000
Country
Hungary
Facility Name
Csongrad Megyei Dr. Bugyi Istvan Korhaz
City
Szentes
ZIP/Postal Code
6600
Country
Hungary
Facility Name
Azienda Ospedaliera Universitaria Integrata di Verona
City
Verona
ZIP/Postal Code
37134
Country
Italy
Facility Name
Osteo-Medic
City
Bia?ystok
ZIP/Postal Code
15-351
Country
Poland
Facility Name
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
City
Bialystok
ZIP/Postal Code
15-077
Country
Poland
Facility Name
ClinicMed Daniluk Nowak Spolka Jawna
City
Bialystok
ZIP/Postal Code
15-879
Country
Poland
Facility Name
Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
City
Bydgoszcz
ZIP/Postal Code
85-068
Country
Poland
Facility Name
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
City
Bydgoszcz
ZIP/Postal Code
85-168
Country
Poland
Facility Name
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Malopolskie Badania Kliniczne
City
Krakow
ZIP/Postal Code
30-002
Country
Poland
Facility Name
Grazyna Pulka Specjalistyczny Osrodek All-med
City
Krak
ZIP/Postal Code
30-033
Country
Poland
Facility Name
Pratia MCM Krakow
City
Krak
ZIP/Postal Code
30-510
Country
Poland
Facility Name
AMED Centrum Medyczne
City
Lodz
ZIP/Postal Code
91-363
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej Lecznica Mak-Med Spolka Cywilna
City
Nadarzyn
ZIP/Postal Code
05-830
Country
Poland
Facility Name
Centrum Badan Klinicznych S.C.
City
Poznan
ZIP/Postal Code
60-773
Country
Poland
Facility Name
Ai Centrum Medyczne
City
Poznan
ZIP/Postal Code
61-113
Country
Poland
Facility Name
Nasz Lekarz Przychodnie Medyczne
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
Rheuma Medicus Zaklad Opieki Zdrowotnej
City
Warszawa
ZIP/Postal Code
02-118
Country
Poland
Facility Name
Ars Rheumatica - Reumatika Centrum Reumatologii
City
Warszawa
ZIP/Postal Code
02-691
Country
Poland
Facility Name
Centrum Medyczne AMED Warszawa Targowek
City
Warszawa
ZIP/Postal Code
03-291
Country
Poland
Facility Name
WroMedica
City
Wroclaw
ZIP/Postal Code
51-685
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Chelyabinsk Regional Clinical Hospital
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
Scientific Research Medical Complex
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Facility Name
Medical Center Revma-Med
City
Kemerovo
ZIP/Postal Code
650070
Country
Russian Federation
Facility Name
Clinic on Maroseyka
City
Moscow
ZIP/Postal Code
101000
Country
Russian Federation
Facility Name
Medical Center Health Family
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
State Healthcare Institution of the Republic of Karelia-Republican Hospital im.V.A.Baranova
City
Petrozavodsk
ZIP/Postal Code
185019
Country
Russian Federation
Facility Name
Polyclinic of Private Security Personnel
City
Saint Petersburg
ZIP/Postal Code
192007
Country
Russian Federation
Facility Name
Clinical Rheumatological Hospital Number 25
City
Saint-Petersburg
ZIP/Postal Code
190068
Country
Russian Federation
Facility Name
LLC Medical Consultation and Research Center-Practice
City
Yarolavl
ZIP/Postal Code
150003
Country
Russian Federation
Facility Name
Clinical Hospital named after NA Semashko
City
Yaroslavl
ZIP/Postal Code
150023
Country
Russian Federation
Facility Name
Hospital Universitario Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Fuenlabrada
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Ramon Y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Hospital Nuestra Senora de la Esperanza
City
Santiago de Compostela
ZIP/Postal Code
15705
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Bradford Teaching Hospitals NHS Foundation Trust
City
Bradford
ZIP/Postal Code
BD5 0NA
Country
United Kingdom
Facility Name
The Princess Alexandra Hospital NHS Trust
City
Harlow
ZIP/Postal Code
CM20 1QX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
35241426
Citation
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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