A Study to Determine the Efficacy and Safety of Deucravac... | NCT04908189 | Trialant
NCT04908189
Sponsor
Bristol-Myers Squibb
Status
Active, not recruiting
Last Update Posted
Jun 13, 2025Actual
Enrollment
729Actual
Phase
Phase 3
Conditions
Psoriatic Arthritis
Interventions
Deucravacitinib
Placebo
Apremilast
Countries
United States
Argentina
Australia
Belgium
Canada
China
Colombia
Czechia
Germany
Hungary
Italy
Japan
Mexico
Poland
Russia
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT04908189
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
IM011-055
Secondary IDs
ID
Type
Description
Link
2020-005099-36
EudraCT Number
U1111-1259-9466
Registry Identifier
WHO
Brief Title
A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Official Title
A Multi-center, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy and Safety of Deucravacitinib in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease Modifying Anti-rheumatic Drugs or Had Previously Received TNFα Inhibitor Treatment
Acronym
Not provided
Organization
Bristol-Myers SquibbINDUSTRY
Status Module
Record Verification Date
Jun 2025
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Jul 15, 2021Actual
Primary Completion Date
Feb 6, 2024Actual
Completion Date
Nov 12, 2026Estimated
First Submitted Date
May 28, 2021
First Submission Date that Met QC Criteria
May 28, 2021
First Posted Date
Jun 1, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2025
Results First Submitted that Met QC Criteria
Mar 26, 2025
Results First Posted Date
Apr 13, 2025Actual
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
Jun 12, 2025
Last Update Posted Date
Jun 13, 2025Actual
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 purpose of this study is to evaluate the safety and efficacy of deucravacitinib versus placebo for the treatment of participants with active PsA who are naïve to biologic disease modifying antirheumatic drugs or had previously received TNFα inhibitor treatment.The long term extension period will provide additional long-term safety and efficacy information.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriatic Arthritis
Keywords
Psoriatic arthritis
PsA
Deucravacitinib
BMS-986165
Apremilast
Otezla
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 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
729Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Deucravacitinib
Experimental
Drug: Deucravacitinib
Placebo
Placebo Comparator
Drug: Deucravacitinib
Other: Placebo
Apremilast
Other
Drug: Apremilast
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Deucravacitinib
Drug
Specified dose on specified days
Deucravacitinib
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: < 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; >5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Diagnosed to have psoriatic arthritis (PsA) of at least 3 months duration at Screening
Meets the Classification Criteria for Psoriatic Arthritis (CASPAR) criteria at Screening
Active plaque psoriatic skin lesion(s) or documented medical history of plaque psoriasis (PsO) at Screening
Active arthritis as shown by ≥ 3 swollen joints and ≥ 3 tender joints at Screening and Day 1
Participant has high sensitivity C-reactive protein (hsCRP) ≥ 3 mg/L at Screening
Must have completed the week 52 treatment for the optional open-label long-term extension period
Exclusion Criteria:
Nonplaque psoriasis at Screening or Day 1
Other autoimmune condition such as systemic lupus erythematous, mixed connective tissue disease, multiple sclerosis, or vasculitis
History of or current inflammatory joint disease other than PsA (e.g., gout, reactive arthritis, rheumatoid arthritis, ankylosing spondylitis, Lyme disease)
Active fibromyalgia
Received an approved or investigational biologic therapy for the treatment of PsA or PsO
Other protocol-defined inclusion/exclusion criteria apply
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
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. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial 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.
Week 16
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:
Tender joint count ≤ 1
Swollen joint count ≤ 1
Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
Patient Global Assessment of PsA disease activity ≤ 20
HAQ-DI ≤ 0.5
Tender enthesial points ≤ 1
Week 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
FACIT-Fatigue evaluates 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 or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline, Week 16
Number of Participants Meeting Dactylitis Resolution at Week 16
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Week 16
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Week 16
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline. HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered.
Week 16
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
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. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
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. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
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. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
Weeks 4, 8, 12, 16
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
Baseline, Weeks 4, 12, 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial 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.
Weeks 4, 8, 12, 16
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right [R]/left [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 supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
Weeks 4, 8, 12, 16
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:
Tender joint count ≤ 1
Swollen joint count ≤ 1
Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
Patient Global Assessment of PsA disease activity ≤ 20
HAQ-DI ≤ 0.5
Tender enthesial points ≤ 1
Weeks 4, 8, 12, 16
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
Baseline, Weeks 4, 12, 16
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
FACIT-Fatigue evaluates 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 or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Dactylitis Resolution
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
Weeks 4, 8, 12, 16
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Weeks 4, 8, 12, 16
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
Baseline, Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
Weeks 2, 4, 8, 12, 16
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
Weeks 2, 4, 8, 12, 16
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 12, 16
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 8, 12, 16
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
Weeks 2, 4, 8, 12, 16
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
Weeks 2, 4, 8, 12, 16
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Week 16
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Baseline, Weeks 4, 16
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16
The American College of Rheumatology (ACR) 20 is defined as 20% improvement over baseline in tender (68) and swollen (66) joint counts and a 20% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000312
OG001312
Title
Denominators
Categories
Title
Measurements
OG000169
OG001123
Secondary
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16
DAS28-CRP is a composite of how many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; CRP in the blood to measure the degree of inflammation, and participant global assessment of disease activity. The results are combined to produce the DAS28-CRP score that range from 1.0 to 9.4, which correlates with the extent of disease activity: < 2.6=disease remission; 2.6 - 3.2=low disease activity; 3.2-5.1=moderate disease activity; >5.1=high disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Secondary
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16
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. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial 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.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:
Tender joint count ≤ 1
Swollen joint count ≤ 1
Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
Patient Global Assessment of PsA disease activity ≤ 20
HAQ-DI ≤ 0.5
Tender enthesial points ≤ 1
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16
FACIT-Fatigue evaluates 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 or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants Meeting Dactylitis Resolution at Week 16
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count >=1 at baseline
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16
The American College of Rheumatology (ACR) 50 is defined as 50% improvement over baseline in tender (68) and swollen (66) joint counts and a 50% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16
The American College of Rheumatology (ACR) 70 is defined as 70% improvement over baseline in tender (68) and swollen (66) joint counts and a 70% improvement in 3 of the 5 remaining core data set measures: Participant Global Assessment of Disease Activity; Participant Global Assessment of Pain; Participant assessment of physical function; Physician Global Assessment of psoriatic arthritis; and Acute phase reactant value of high sensitivity C-reactive protein (hsCRP). Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)
HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in HAQ-DI indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
Posted
Mean
Standard Deviation
score on a scale
Baseline, Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16
Number of participants who achieve a clinically meaningful improvement (≥ 0.35 improvement from baseline) in HAQ-DI score among participants with a HAQ-DI score ≥ 0.35 at baseline. HAQ-DI is a patient-reported outcome measure that assesses the degree of difficulty a participant has experienced during the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2 to 3 items. For each item in the questionnaire, the level of activity is scored from 0 to 3, with 0 representing "no difficulty," 1 representing "some difficulty," 2 representing "much difficulty," and 3 representing "unable to do." increasing scores for the 8 disability categories indicate increasing level of difficulty. HAQDI is calculated by summing the adjusted categories scores and dividing by the number of categories answered.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements
Posted
Count of Participants
Participants
Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)
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. PASI 75 is the number of participants who experience at least a 75% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)
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. PASI 90 is the number of participants who experience at least a 90% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)
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. PASI 100 is the number of participants who experience at least a 100% improvement in PASI score as compared with the baseline value. Baseline is defined as the last measurement on or prior to date/time of first dose of study treatment.
All randomized participants of deucravacitinib and placebo with at least 3% body surface area (BSA) and at least static physician's global assessment (sPGA) 2 at baseline as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical component summary (PCS) consists of these 4 subscales: Physical functioning, Role-physical, Bodily pain, General health. The scores range from 0 to 100, with a higher score indicating better quality of life. The PCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 PCS indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by Leeds Enthesitis Index (LEI). An overall score of 0 to 6 is derived from the presence or absence of tenderness at 6 enthesial 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.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)
Number of participants meeting enthesitis resolution (score of 0) among participants with enthesitis at Baseline by SPARCC. The SPARCC Enthesitis Index has a 0 to 16 score that is derived from the evaluation of 8 locations: the greater trochanter (right [R]/left [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 supraspinatus insertion (R/L). A higher count indicates a higher enthesitis burden based on the current evaluation.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by SPARCC
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)
Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16:
Tender joint count ≤ 1
Swollen joint count ≤ 1
Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3%
Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15
Patient Global Assessment of PsA disease activity ≤ 20
HAQ-DI ≤ 0.5
Tender enthesial points ≤ 1
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) Score
SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The mental component summary (MCS) of the SF-36 consists of these 4 subscales: Vitality, Social functioning, Role-emotional, Mental health. The scores range from 0 to 100, with a higher score indicating better quality of life. The MCS summary scores will be calculated by taking a weighted linear combination of the individual subscales. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in SF-36 MCS indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 MCS baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score
FACIT-Fatigue evaluates 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 or symptoms of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The recall period is 7 days. Each item is rated on a 5-point Likert scale ranging from 0 = "not at all" to 4 = "very much." Sum scores for the 13 items range from 0 through 52, where higher scores indicate less fatigue. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in FACIT-Fatigue indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants Meeting Dactylitis Resolution
Number of participants meeting dactylitis resolution at Week 16 among the participants with dactylitis at baseline, where resolution is defined as a tender dactylitis count of 0 in participants with a tender dactylitis count ≥ 1 at baseline. The number of digits in hands and feet with dactylitis will be counted by a blinded assessor.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count >=1 at baseline
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 Score
The Psoriatic Arthritis Impact of Disease (PsAID) is a 12-item self-report that measures PsA symptoms and impact of disease. Each item is scored on a 0 to 10 numeric rating scale with a 1-week recall period. The PsAID has a total score, with a higher value indicating worse health. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in PsAID indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) Score
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAPSA indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAPSA baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity Response
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease Remission
The Disease Activity Index for Psoriatic Arthritis Score is a composite measure to assess peripheral joint involvement that is based upon numerical summation of 5 variables of disease activity: tender joint count (0-68), swollen joint count (0-66), Participant Global Assessment of Disease Activity (0 to 10 cm VAS, 0= excellent and 10= poor), Participant Global Assessment of Pain (0 to 10 centimeter [cm] visual analog scale (VAS), 0= no pain, 10= worst possible pain), and C-reactive protein. A higher DAPSA score indicated more active disease activity.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1
The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with a baseline PGA-F score of >= 3
Posted
Count of Participants
Participants
Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
OG000
Secondary
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Score
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline in DAS28-CRP indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Secondary
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity Response
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Secondary
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease Remission
The DAS28-CRP is a composite outcome measure that assesses: 1) How many joints in the hands (including metacarpophalangeal and proximal interphalangeal joints but excluding DIPs), wrists, elbows, shoulders, and knees are swollen and/or tender out of a total of 28; 2) CRP in the blood to measure the degree of inflammation; 3) Participant Global Assessment of Disease Activity. DAS28-CRP scores range from 1.0 to 9.4, where lower scores indicate less disease activity. The results are combined to produce the DAS28-CRP score, which correlates with the extent of disease activity: < 2.6: Disease remission, 2.6 to 3.2: Low disease activity, 3.2 to 5.1: Moderate disease activity, > 5.1: High disease activity.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)
The Psoriatic Arthritis Disease Activity Score (PASDAS) is a composite measure calculated from the Physician Global Assessment of PsA, the Participant Global Assessment of Disease Activity, the Short Form-36 PCS, the swollen joint count, the tender joint count, the Enthesitis (LEI), the Dactylitis (LDI) (Basic), and the High-sensitivity C-reactive protein (hsCRP). The range of PASDAS is 0-10. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PASDAS baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)
Four domains are used to calculate the modified Composite Psoriatic Disease Activity Index (mCPDAI): joints (66 swollen joint count and 68 tender joint count; Health Assessment Questionnaire), skin (PASI and DLQI), dactylitis (a simple count of each digit involved), and enthesitis (number of tendons/fascia insertion sites showing enthesitis scored from 0 to 4, based on palpation of Achilles tendon and bilateral plantar fasciae insertion). The mCPDAI is scored using a 4 point scale from 0 (no disease activity) to 3 (most severe disease activity), giving an mCPDAI score range of 0 through 12. A higher score indicates more active disease activity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with mCPDAI baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Secondary
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)
The Psoriatic Arthritis Response Criteria (PsARC) consists of 4 measurements: tender joint count, swollen joint count, Physician Global Assessment of PsA, and Participant Global Assessment of Disease Activity. In order to be classified as a PsARC responder, participants must achieve improvement in 2 of 4 measures, 1 of which must be joint pain or swelling, without worsening in any measure. Improvement in each of the measures is defined below: 1) Decrease of ≥ 30% in tender joint counts; 2) Decrease of ≥ 30% in swollen joint counts; 3) Decrease of ≥ 20% in Physician Global Assessment of PsA; 4) Decrease of ≥ 20% in Participant's Global Assessment of Disease Activity
All randomized participants of deucravacitinib and placebo as pre-specified in protocol
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) Score
BASDAI consists of a 0 to 10 scale measuring discomfort, pain, and fatigue in response to 6 questions pertaining to the 5 major symptoms of ankylosing spondylitis: 1) Fatigue (medical); 2) Spinal pain; 3) Joint pain and swelling; 4) Areas of localized tenderness; 5) Morning stiffness duration; 6) Morning stiffness severity. A higher count indicates worse disease. Each individual question response is scaled to a 0-10 score by dividing by 10, and the BASDAI is derived using the following formula: BASDAI = ((Q1 + Q2 + Q3 + Q4) + ((Q5 + Q6) / 2)) / 5
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with spondylitis in addition to peripheral joint involvement as their presentation of PsA
Posted
Count of Participants
Participants
Weeks 2, 4, 8, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16
The WPAI is a 6-item questionnaire that includes 2 visual analog scales: 1 for impact of disease on work and 1 for impact of disease on other daily activities. The WPAI also assesses absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity (overall work impairment/absenteeism plus presenteeism), and activity impairment. These sub-scores are transformed to impairment percentages (range from 0 to 100), with higher numbers indicating greater impairment and less productivity. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with WPAI baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Secondary
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its Subcomponents
The European Quality of Life 5D-5L Scale (EQ-5D-5L) assesses general health-related quality of life. Health is defined in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Responses are coded so that a '1' indicates no problem, and '5' indicates the most serious problem. The responses for the 5 dimensions are combined in a 5-digit number. Change from Baseline in 5-level EuroQol 5-dimension (EQ-5D-5L) Utility Scores. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with EQ-5D-5L baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Secondary
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)
The Patient-Reported Outcome Measures Information System Sleep Disturbance Short Form 8b assess self-reported perceptions of sleep quality, sleep depth, and restoration associated with sleep. This includes perceived difficulties and concerns with getting to sleep or staying asleep, as well as perceptions of the adequacy of and satisfaction with sleep. The items are evaluated on a 5-point Likert scale ranging from 1 = "not at all" to 5 = "very much" with a 7-day recall period. Higher score means more active disease. Change from baseline is defined as value at post-baseline visit. A negative change from baseline indicates an improvement.
All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PROMIS baseline and post-baseline measurements
Posted
Mean
Standard Deviation
Score on a scale
Baseline, Weeks 4, 12, 16
ID
Title
Description
OG000
Deucravacitinib
Deucravacitinib 6 mg daily
OG001
Placebo
Placebo daily
Units
Counts
Participants
Time Frame
All-cause mortality was assessed for all participants from date of randomization to their study completion (up to approximately 30 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 30 months)
Description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0021 affected105 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Renal oncocytoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Cerebral infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Guillain-Barre syndrome
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Intracranial pressure increased
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Lacunar infarction
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Spinal claudication
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Depression
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Panic attack
Psychiatric disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Acute kidney injury
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0011 affected311 at risk
EG0020 affected105 at risk
EG003
Calculus urinary
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0011 affected311 at risk
EG0020 affected105 at risk
EG003
Hypertonic bladder
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Ureterolithiasis
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0021 affected105 at risk
EG003
Urinary incontinence
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Cystocele
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Varicocele
Reproductive system and breast disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Nasal polyps
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Nasal septum deviation
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Nasal septum disorder
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Nasal turbinate hypertrophy
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0010 affected311 at risk
EG0020 affected105 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0011 affected311 at risk
EG0020 affected105 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0000 affected312 at risk
EG0011 affected311 at risk
EG0020 affected105 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG00011 affected312 at risk
EG00115 affected311 at risk
EG00211 affected105 at risk
EG00310 affected292 at risk
EG0046 affected292 at risk
EG00511 affected90 at risk
EG0062 affected245 at risk
EG0075 affected254 at risk
EG0083 affected70 at risk
Nausea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0007 affected312 at risk
EG0016 affected311 at risk
EG0027 affected105 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00022 affected312 at risk
EG00117 affected311 at risk
EG0027 affected105 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00014 affected312 at risk
EG00121 affected311 at risk
EG0024 affected105 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG00019 affected312 at risk
EG00113 affected311 at risk
EG0024 affected105 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0003 affected312 at risk
EG0013 affected311 at risk
EG0022 affected105 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0005 affected312 at risk
EG00110 affected311 at risk
EG0022 affected105 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG00013 affected312 at risk
EG00111 affected311 at risk
EG0028 affected105 at risk
EG003
Hypertension
Vascular disorders
MedDRA 27.1
Systematic Assessment
EG0008 affected312 at risk
EG0018 affected311 at risk
EG0027 affected105 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.