Efficacy and Safety of BMS-986165 Compared With Placebo i... | NCT03881059 | Trialant
NCT03881059
Sponsor
Bristol-Myers Squibb
Status
Completed
Last Update Posted
Feb 15, 2022Actual
Enrollment
203Actual
Phase
Phase 2
Conditions
Active Psoriatic Arthritis
Interventions
BMS-986165 Placebo
BMS-986165 Dose A
BMS-986165 Dose B
Ustekinumab
Ustekinumab Placebo
Countries
United States
Czechia
Germany
Hungary
Italy
Poland
Russia
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT03881059
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-084
Secondary IDs
ID
Type
Description
Link
2018-004293-10
EudraCT Number
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)
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jan 2022
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 1, 2019Actual
Primary Completion Date
Apr 27, 2020Actual
Completion Date
Jan 27, 2021Actual
First Submitted Date
Mar 18, 2019
First Submission Date that Met QC Criteria
Mar 18, 2019
First Posted Date
Mar 19, 2019Actual
Results Waived
Not provided
Results First Submitted Date
Apr 23, 2021
Results First Submitted that Met QC Criteria
Apr 23, 2021
Results First Posted Date
May 17, 2021Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jan 25, 2022
Last Update Posted Date
Feb 15, 2022Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Bristol-Myers SquibbINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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).
Conditions Module
Conditions
Active Psoriatic Arthritis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 2
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
203Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Part A: Placebo
Placebo Comparator
Other: BMS-986165 Placebo
Part A: BMS-986165 Dose A
Experimental
Drug: BMS-986165 Dose A
Part A: BMS-986165 Dose B
Experimental
Drug: BMS-986165 Dose B
Part B: Ustekinumab + BMS-986165 Placebo
Experimental
Other: BMS-986165 Placebo
Drug: Ustekinumab
Part B: BMS-986165 Dose A + Ustekinumab Placebo
Experimental
Drug: BMS-986165 Dose A
Other: Ustekinumab Placebo
Part B: BMS-986165 Dose B + Ustekinumab Placebo
Experimental
Drug: BMS-986165 Dose B
Other: Ustekinumab Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BMS-986165 Placebo
Other
Participants will receive BMS-986165 matching placebo QD
Part A: Placebo
Part B: Ustekinumab + BMS-986165 Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
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)
16 weeks after first dose
Secondary Outcomes
Measure
Description
Time Frame
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.
Other Outcomes
Not provided
Eligibility Module
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
Deodhar A, Nowak M, Ye JY, Lehman T, Banerjee S, Mease PJ. Efficacy and Safety of Deucravacitinib, a Selective, Allosteric TYK2 Inhibitor, by Baseline DMARD Use in a Phase 2 Psoriatic Arthritis Study: A Post Hoc Analysis. Rheumatol Ther. 2025 Oct;12(5):873-887. doi: 10.1007/s40744-025-00776-4. Epub 2025 Jul 5.
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
FG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Periods
Title
Milestones
Reasons Not Completed
Treatment Period - Part A
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Sep 23, 2019
Apr 23, 2021
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Belgium
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
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.
Who Masked
ParticipantInvestigator
BMS-986165 Dose A
Drug
Participants will receive BMS-986165 Dose A QD.
Part A: BMS-986165 Dose A
Part B: BMS-986165 Dose A + Ustekinumab Placebo
BMS-986165 Dose B
Drug
Participants will receive BMS-986165 dose B QD.
Part A: BMS-986165 Dose B
Part B: BMS-986165 Dose B + Ustekinumab Placebo
Ustekinumab
Drug
Participants will receive ustekinumab SQ injection QD.
Part B: Ustekinumab + BMS-986165 Placebo
Ustekinumab Placebo
Other
Participants will receive ustekinumab SQ matching placebo QD
Part B: BMS-986165 Dose A + Ustekinumab Placebo
Part B: BMS-986165 Dose B + Ustekinumab Placebo
From baseline (day of the first dose) to 16 weeks after first dose
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.
16 weeks after first dose
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.
From baseline (day of the first dose) to 16 weeks after first dose
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)
16 weeks after first dose
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)
16 weeks after first dose
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.
16 weeks after first dose
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.
16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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
16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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
16 weeks after first dose
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.
16 weeks after first dose
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).
16 weeks after first dose
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
16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
16 weeks after first dose
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.
From baseline (day of first dose) to 16 weeks after first dose
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.
From baseline (day of the first dose) to 16 weeks after first dose
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.
From baseline (day of the first dose) to 16 weeks after first dose
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.
From baseline (day of the first dose) to 16 weeks after first dose
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.
From baseline (day of the first dose) to 16 weeks after first dose
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.
16 weeks after first dose
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.
16 weeks after first dose
Change From Baseline in Electrocardiogram (ECG) Results
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Electrocardiogram (ECG) Heart Rate
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Diastolic Blood Pressure
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Heart Rate
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Respiratory Rate
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Systolic Blood Pressure
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Temperature
From baseline (day of first dose) to 16 weeks after first dose
Change From Baseline in Vital Signs - Weight
From baseline (day of first dose) to 16 weeks after first dose
Covina
California
91722
United States
University of California at San Diego Medical Center
La Jolla
California
92039
United States
Arthritis & Rheumatic Disease Specialties
Aventura
Florida
33180
United States
San Marcus Research Clinic
Miami Lakes
Florida
33014
United States
Omega Research Consultants - Metrowest
Orlando
Florida
32835
United States
Integral Rheumatology & Immunology Specialists
Plantation
Florida
33324
United States
BayCare Medical Group
St. Petersburg
Florida
33705
United States
University of South Florida - Morsani College of Medicine
Tampa
Florida
33612
United States
Heartland Research Associates - East Wichita
Wichita
Kansas
67207
United States
Arthritis Center of Lexington
Lexington
Kentucky
40504
United States
Clinical Pharmacology Study Group
Worcester
Massachusetts
01605
United States
Arthritis Associates
Hattiesburg
Mississippi
39402
United States
Dartmouth-Hitchcock Medical Center
Lebanon
New Hampshire
03756
United States
Atlantic Coast Rheumatology
Toms River
New Jersey
08755
United States
Albuquerque Center for Rheumatology
Albuquerque
New Mexico
87102
United States
The Center for Rheumatology-Albany
Albany
New York
12203
United States
University of Rochester Medical Center
Rochester
New York
14642
United States
Joint Muscle Medical Care and Research Institute - Lilington Office
Charlotte
North Carolina
28204
United States
DJL Clinical Research
Charlotte
North Carolina
28210
United States
PMG Research of Salisbury
Salisbury
North Carolina
28144
United States
Paramount Medical Research and Consulting
Middleburg Heights
Ohio
44130
United States
East Penn Rheumatology Associates
Bethlehem
Pennsylvania
18015
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Low Country Rheumatology
Summerville
South Carolina
29486
United States
West Tennessee Research Institute
Jackson
Tennessee
38305
United States
Office of Ramesh C. Gupta, MD
Memphis
Tennessee
38119
United States
Pioneer Research Solutions
Cypress
Texas
77429-5890
United States
Southwest Rheumatology Research
Mesquite
Texas
75150
United States
Seattle Rheumatology Associates
Seattle
Washington
98122
United States
Arthritis Northwest Rheumatology
Spokane
Washington
99204
United States
L.K.N. Arthrocentrum, s.r.o
Hlu?
748 01
Czechia
CCR Ostrava
Ostrava
702 00
Czechia
Revmatologie MUDr. Klara Sirova s.r.o.
Ostrava
702 00
Czechia
Arthrocentrum
Prague
101 00
Czechia
Revmatologicky Ustav
Prague
128 00
Czechia
CCR Prague
Prague
130 00
Czechia
Nuselska Poliklinika
Prague
140 00
Czechia
Affidea Praha
Praha 11 Chodov
148 00
Czechia
PV-Medical Services, s.r.o.
Zlín
760 01
Czechia
Charite Universitatsmedizin Berlin
Berlin
10117
Germany
Rheumatologische Schwerpunktpraxis PD Dr. med. Brandt Jurgens
Berlin
12161
Germany
Universitatsklinikum Erlangen
Erlangen
91054
Germany
Universitatsklinikum Frankfurt
Frankfurt am Main
60590
Germany
HRF II - Hamburger Rheuma Forschungszentrum II - MVZ fur Rheumatologie und Autoimmunmedizin Hamburg
Hamburg
20095
Germany
SMO.MD GmbH
Magdeburg
39120
Germany
Universitatsmedizin Mannheim
Mannheim
68167
Germany
Klinikum der Universitat Munchen
München
80336
Germany
Clinexpert Gyogycentrum
Budapest
1033
Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest
1062
Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen
4032
Hungary
CRU Hungary Egeszsegugyi es Szolgaltato Korlatolt Felelossegu Tarsasag
Miskolc
3529
Hungary
Aranyklinika
Szeged
6720
Hungary
Csongrad Megyei Dr. Bugyi Istvan Korhaz
Szentes
6600
Hungary
CMed Rehabilitacios es Diagnosztikai Kozpont
Székesfehérvár
8000
Hungary
Azienda Ospedaliera Universitaria Integrata di Verona
Verona
37134
Italy
Osteo-Medic
Bia?ystok
15-351
Poland
Gabinet Internistyczno-Reumatologiczny Piotr Adrian Klimiuk
Bialystok
15-077
Poland
ClinicMed Daniluk Nowak Spolka Jawna
Bialystok
15-879
Poland
Nasz Lekarz Osrodek Badan Klinicznych - Bydgoszcz
Bydgoszcz
85-068
Poland
Szpital Uniwersytecki Number 2 im. dr. Jana Biziela w Bydgoszczy
Bydgoszcz
85-168
Poland
Centrum Kliniczno Badawcze J Brzezicki B Gornikiewicz Brzezicka Lekarze Spolka Partnerska
Elblag
82-300
Poland
Indywidualna Specjalistyczna Praktyka Lekarska Lek. Med. Barbara Bazela
Strand V, Gossec L, Coates LC, Ogdie A, Choi J, Becker B, Zhuo J, Lehman T, Nowak M, Elegbe A, Mease PJ, Deodhar A. Improvements in Patient-Reported Outcomes After Treatment With Deucravacitinib in Patients With Psoriatic Arthritis: Results From a Randomized Phase 2 Trial. Arthritis Care Res (Hoboken). 2024 Aug;76(8):1139-1148. doi: 10.1002/acr.25333. Epub 2024 May 7.
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.
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
FG00066 subjects
FG00170 subjects
FG00267 subjects
COMPLETED
FG00058 subjects
FG00163 subjects
FG00259 subjects
NOT COMPLETED
FG0008 subjects
FG0017 subjects
FG0028 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0013 subjects
FG0024 subjects
Randomized by mistake with study treatment
FG0000 subjects
FG0011 subjects
FG0021 subjects
Withdrawal by Subject
FG0005 subjects
FG0012 subjects
FG0023 subjects
Other reasons
FG0002 subjects
FG0011 subjects
FG0020 subjects
Treatment Period - Part B
Type
Comment
Milestone Data
STARTED
Participation in Part B was optional. Some of the participants who completed Part A decided not to continue in Part B
FG00055 subjects
FG00160 subjects
FG00258 subjects
Participants Maintaining Same Treatment as in Part A
FG0000 subjects
FG00113 subjects
FG00216 subjects
Participants Treated With Ustekinumab in Part B
FG00055 subjects
FG00147 subjects
FG00242 subjects
COMPLETED
FG00047 subjects
FG00154 subjects
FG00247 subjects
NOT COMPLETED
FG0008 subjects
FG0016 subjects
FG00211 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0023 subjects
Death
FG000
All treated participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
BG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
BG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00066
BG00170
BG00267
BG003203
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00048.5± 13.17
BG00150.5± 13.69
BG00250.5± 13.75
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00040
BG00130
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0007
BG0014
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
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)
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG00031.8(20.6 to 43.1)
OG00152.9(41.2 to 64.6)
OG00262.7(51.1 to 74.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
OG002
Regression, Logistic
<0.001
Slope Coefficient of Dose
0.11
2-Sided
95
0.05
0.17
Superiority
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with at least 3% Body Surface Area (BSA) involvement at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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)
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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)
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with dactylitis count ≥ 1 at baseline
Posted
Mean
Standard Error
Digits with dactylitis
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with LDI score > 0 at baseline
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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
All treated participants with dactylitis count (tender digits only) ≥ 1 at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with LEI score ≥ 1 at baseline
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with SPARCC enthesitis index score ≥ 1 at baseline
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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
All treated participants with LEI score ≥ 1 at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with SPARCC enthesitis index score ≥ 1 at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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).
All treated participants with PGA-F score ≥ 3 at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with available measurements
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with evidence of psoriatic arthritis spondylitis at baseline
Posted
Mean
Standard Error
Score on a scale
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with available measurements
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Mean
Standard Error
Score on a scale
From baseline (day of the first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Secondary
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.
All treated participants with at least 3% Body Surface Area (BSA) involvement at baseline
Posted
Number
95% Confidence Interval
Percent of Participants
16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
Secondary
Change From Baseline in Electrocardiogram (ECG) Results
All treated participants with available measurements
Posted
Mean
Standard Deviation
msec
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Electrocardiogram (ECG) Heart Rate
All treated participants with available measurements
Posted
Mean
Standard Deviation
beats/min
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Diastolic Blood Pressure
All treated participants with available measurements
Posted
Mean
Standard Deviation
mmHg
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Heart Rate
All treated participants with available measurements
Posted
Mean
Standard Deviation
beats/min
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Respiratory Rate
All treated participants with available measurements
Posted
Mean
Standard Deviation
breaths/min
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Systolic Blood Pressure
All treated participants with available measurements
Posted
Mean
Standard Deviation
mmHg
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Temperature
All treated participants with available measurements
Posted
Mean
Standard Deviation
Celsius degree (C)
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Secondary
Change From Baseline in Vital Signs - Weight
All treated participants with available measurements
Posted
Mean
Standard Deviation
Kg
From baseline (day of first dose) to 16 weeks after first dose
ID
Title
Description
OG000
Placebo
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
OG001
BMS-986165 6 mg
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 6 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
Time Frame
All-cause mortality was assessed from date of first dose to study completion (up to approximately 21 months). Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 13 months).
Description
All participants receiving treatment either only in Part A or in Part A + Part B
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Only Part A:Placebo
In Part A, Placebo matching BMS-986165.
0
11
2
11
6
11
EG001
Only Part A:BMS-986165 6 mg QD
In Part A, BMS-986165 6 mg administered QD for 16 weeks.
0
10
0
10
7
10
EG002
Only Part A:BMS-986165 12 mg QD
In Part A, BMS-986165 12 mg administered QD for 16 weeks.
0
9
0
9
7
9
EG003
Part A: Placebo + Part B: Ustekinumab SQ
In Part A, Placebo matching BMS-986165. In Part B, Ustekinumab SQ.
0
55
0
55
34
55
EG004
BMS-986165 6 mg in Part A and Part B
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, BMS-986165 at 6 mg
0
13
1
13
13
13
EG005
Part A: BMS-986165 6 mg QD - Part B: Ustekinumab SQ
In Part A, BMS-986165 6 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ.
1
47
3
47
30
47
EG006
BMS-986165 12 mg in Part A and Part B
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, BMS-986165 at 12 mg
0
16
0
16
11
16
EG007
Part A: BMS-986165 12 mg QD - Part B: Ustekinumab SQ
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, Ustekinumab SQ
1
42
4
42
31
42
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Atrial fibrillation
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG0030 affected55 at risk
EG0040 affected13 at risk
EG0050 affected47 at risk
EG0060 affected16 at risk
EG0071 affected42 at risk
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Death
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Chest injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Neuropathy peripheral
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Metastatic carcinoid tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphopenia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG0030 affected55 at risk
EG0040 affected13 at risk
EG0052 affected47 at risk
EG0060 affected16 at risk
EG0073 affected42 at risk
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Palpitations
Cardiac disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Cataract
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Conjunctival haemorrhage
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Macular fibrosis
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Aphthous ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Noninfective sialoadenitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Asthenia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Pyrexia
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hepatomegaly
Hepatobiliary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
COVID-19
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Ear infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Gingivitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Herpes simplex
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Eye injury
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Tooth fracture
Injury, poisoning and procedural complications
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Body temperature increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Weight increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Dyslipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hyperglycaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Muscle discomfort
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Headache
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected10 at risk
EG0021 affected9 at risk
EG003
Renal failure
Renal and urinary disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Pulmonary mass
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Nail bed inflammation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Skin exfoliation
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Skin ulcer
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hypertension
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Eosinophilia
Blood and lymphatic system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Eye haemorrhage
Eye disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Diverticulum intestinal
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Flatulence
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Gastrointestinal inflammation
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Ileal ulcer
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Large intestine polyp
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Retching
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Stomatitis
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Subileus
Gastrointestinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Injection site discomfort
General disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Peripheral swelling
General disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Furuncle
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Oral herpes
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Oral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Respiratory tract infection viral
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Viral infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Blood pressure increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Haemoglobin decreased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Platelet count increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Transaminases increased
Investigations
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hyperlipidaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Hypertriglyceridaemia
Metabolism and nutrition disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Rotator cuff syndrome
Musculoskeletal and connective tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Adenoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Gastrointestinal neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Mesenteric neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0021 affected9 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Respiratory disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Dermatitis acneiform
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Intertrigo
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0002 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Rash papular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Rash vesicular
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Rosacea
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0011 affected10 at risk
EG0020 affected9 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 23.1
Systematic Assessment
EG0000 affected11 at risk
EG0010 affected10 at risk
EG0021 affected9 at risk
EG003
Post thrombotic syndrome
Vascular disorders
MedDRA 23.1
Systematic Assessment
EG0001 affected11 at risk
EG0010 affected10 at risk
EG0020 affected9 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG000-0.11± 0.066
OG001-0.37± 0.065
OG002-0.39± 0.067
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00054
OG00159
OG00252
Title
Denominators
Categories
Title
Measurements
OG00020.4(9.6 to 31.1)
OG00142.4(29.8 to 55.0)
OG00259.6(46.3 to 73.0)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG0002.3± 0.97
OG0015.6± 0.94
OG0025.8± 0.97
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG00010.6(3.2 to 18.0)
OG00124.3(14.2 to 34.3)
OG00232.8(21.6 to 44.1)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG0001.5(0.0 to 4.5)
OG00114.3(6.1 to 22.5)
OG00219.4(9.9 to 28.9)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG00022.7(12.6 to 32.8)
OG00137.1(25.8 to 48.5)
OG00243.3(31.4 to 55.1)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG0006.1(0.3 to 11.8)
OG00124.3(14.2 to 34.3)
OG00225.4(15.0 to 35.8)
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG000-0.9± 0.15
OG001-1.7± 0.15
OG002-1.7± 0.15
Units
Counts
Participants
OG00025
OG00133
OG00227
Title
Denominators
Categories
Title
Measurements
OG000-1.8± 0.40
OG001-2.0± 0.38
OG002-2.5± 0.38
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00024
OG00130
OG00223
Title
Denominators
Categories
Title
Measurements
OG000-28.3± 8.87
OG001-41.8± 8.35
OG002-44.5± 8.90
Units
Counts
Participants
OG00025
OG00130
OG00224
Title
Denominators
Categories
Title
Measurements
OG00060.0(40.8 to 79.2)
OG00176.7(61.5 to 91.8)
OG00279.2(62.9 to 95.4)
Units
Counts
Participants
OG00031
OG00139
OG00226
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 0.27
OG001-1.5± 0.25
OG002-1.7± 0.28
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00034
OG00143
OG00234
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 0.54
OG001-2.9± 0.48
OG002-3.1± 0.51
Units
Counts
Participants
OG00031
OG00139
OG00226
Title
Denominators
Categories
Title
Measurements
OG00022.6(7.9 to 37.3)
OG00151.3(35.6 to 67.0)
OG00250.0(30.8 to 69.2)
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00034
OG00143
OG00234
Title
Denominators
Categories
Title
Measurements
OG00017.6(4.8 to 30.5)
OG00151.2(36.2 to 66.1)
OG00241.2(24.6 to 57.7)
Units
Counts
Participants
OG00012
OG00114
OG00220
Title
Denominators
Categories
Title
Measurements
OG0000(0.0 to 0.0)
OG00121.4(0.0 to 42.9)
OG00250.0(28.1 to 71.9)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG0007.6(1.2 to 14.0)
OG00122.9(13.0 to 32.7)
OG00223.9(13.7 to 34.1)
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00063
OG00170
OG00266
Title
Denominators
Categories
Title
Measurements
OG000-1.1± 0.21
OG001-2.0± 0.20
OG002-2.1± 0.20
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG000-13.3± 2.20
OG001-23.2± 2.16
OG002-25.6± 2.23
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG00054.5(42.5 to 66.6)
OG00175.7(65.7 to 85.8)
OG00274.6(64.2 to 85.0)
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00015
OG00119
OG00216
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 0.55
OG001-2.0± 0.48
OG002-2.2± 0.57
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG0000.7± 1.00
OG0013.6± 0.97
OG0023.5± 1.01
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG000-1.0± 0.26
OG001-2.1± 0.26
OG002-2.3± 0.26
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00065
OG00167
OG00265
Title
Denominators
Categories
Title
Measurements
OG0002.8± 1.17
OG0015.6± 1.16
OG0027.2± 1.18
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG000-1.2± 0.69
OG001-1.9± 0.67
OG002-2.7± 0.70
OG002
BMS-986165 12 mg
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)
Units
Counts
Participants
OG00066
OG00170
OG00267
Title
Denominators
Categories
Title
Measurements
OG00015.2(6.5 to 23.8)
OG00138.6(27.2 to 50.0)
OG00240.3(28.6 to 52.0)
In Part A, BMS-986165 12 mg administered QD for 16 weeks. In Part B, participants received either BMS-986165 at 12 mg (if they achieved minimal disease activity (MDA) in Part A) or Ustekinumab SQ (if they did not achieve MDA in Part A)