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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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04908189
Enrollment
729
Registered
2021-06-01
Start date
2021-07-15
Completion date
2026-11-12
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriatic Arthritis

Keywords

Psoriatic arthritis, PsA, Deucravacitinib, BMS-986165, Apremilast, Otezla

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.

Interventions

DRUGDeucravacitinib

Specified dose on specified days

OTHERPlacebo

Specified dose on specified days

DRUGApremilast

Specified dose on specified days

Sponsors

Bristol-Myers Squibb
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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/

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16Week 16The 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.

Secondary

MeasureTime frameDescription
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16Baseline, Week 16DAS28-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.
Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16Baseline, Week 16HAQ-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.
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16Week 16PASI 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.
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16Baseline, Week 16SF-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.
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16Week 16Number 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.
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16Week 16Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16Baseline, Week 16FACIT-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.
Number of Participants Meeting Dactylitis Resolution at Week 16Week 16Number 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.
Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16Week 16The 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.
Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16Week 16The 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.
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Baseline, Weeks 2, 4, 8, 12, 16HAQ-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.
Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16Week 16Number 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.
Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Weeks 4, 8, 12, 16PASI 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.
Number of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Weeks 4, 8, 12, 16PASI 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.
Number of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Weeks 4, 8, 12, 16PASI 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.
Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreBaseline, Weeks 4, 12, 16SF-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.
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Weeks 4, 8, 12, 16Number 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.
Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Weeks 4, 8, 12, 16Number 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.
Number of Participants Meeting Achievement of Minimal Disease Activity (MDA)Weeks 4, 8, 12, 16Number participants meeting achievement of MDA where an MDA response is achievement of 5 of 7 following outcomes at Week 16: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1
Change From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreBaseline, Weeks 4, 12, 16SF-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.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreBaseline, Weeks 2, 4, 8, 12, 16FACIT-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.
Number of Participants Meeting Dactylitis ResolutionWeeks 4, 8, 12, 16Number 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.
Change From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreBaseline, Weeks 2, 4, 8, 12, 16The 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.
Change From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreBaseline, Weeks 2, 4, 8, 12, 16The 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.
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeeks 2, 4, 8, 12, 16The 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.
Number of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeeks 2, 4, 8, 12, 16The 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.
Number of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Weeks 4, 8, 12, 16The overall condition of the fingernails is rated on a 5-point scale: 0 = clear, 1 = minimal, 2 = mild, 3 = moderate, and 4 = severe.
Change From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreBaseline, Weeks 2, 4, 8, 12, 16The 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.
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeeks 2, 4, 8, 12, 16The 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.
Number of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeeks 2, 4, 8, 12, 16The 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 in Psoriatic Arthritis Disease Activity Score (PASDAS)Baseline, Weeks 4, 12, 16The 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.
Change From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Baseline, Weeks 4, 8, 12, 16Four 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.
Number of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Weeks 2, 4, 8, 12, 16The 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
Number of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeeks 2, 4, 8, 12, 16BASDAI 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
Change From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Baseline, Week 16The 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.
Change From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsBaseline, Weeks 4, 16The 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.
Change From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Baseline, Weeks 4, 12, 16The 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.

Countries

Argentina, Australia, Belgium, Canada, China, Colombia, Czechia, Germany, Hungary, Italy, Japan, Mexico, Poland, Russia, Spain, Taiwan, United Kingdom, United States

Contacts

STUDY_DIRECTORBristol-Myers Squibb

Bristol-Myers Squibb

Participant flow

Participants by arm

ArmCount
Deucravacitinib
Deucravacitinib 6 mg daily
312
Placebo
Placebo daily
312
Apremilast
Apremilast 30 mg twice daily
105
Total729

Baseline characteristics

CharacteristicDeucravacitinibPlaceboApremilastTotal
Age, Continuous48.7 Years
STANDARD_DEVIATION 11.73
49.3 Years
STANDARD_DEVIATION 12.18
49.1 Years
STANDARD_DEVIATION 13.47
49.0 Years
STANDARD_DEVIATION 12.17
Ethnicity (NIH/OMB)
Hispanic or Latino
54 Participants50 Participants16 Participants120 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
195 Participants200 Participants64 Participants459 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
63 Participants62 Participants25 Participants150 Participants
Race (NIH/OMB)
American Indian or Alaska Native
13 Participants7 Participants4 Participants24 Participants
Race (NIH/OMB)
Asian
54 Participants45 Participants28 Participants127 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants1 Participants0 Participants1 Participants
Race (NIH/OMB)
Unknown or Not Reported
22 Participants19 Participants8 Participants49 Participants
Race (NIH/OMB)
White
223 Participants240 Participants65 Participants528 Participants
Sex: Female, Male
Female
153 Participants168 Participants56 Participants377 Participants
Sex: Female, Male
Male
159 Participants144 Participants49 Participants352 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
EG006
affected / at risk
EG007
affected / at risk
EG008
affected / at risk
deaths
Total, all-cause mortality
0 / 3121 / 3120 / 1050 / 2921 / 2920 / 900 / 2451 / 2540 / 70
other
Total, other adverse events
89 / 31293 / 31139 / 10590 / 292106 / 29232 / 9058 / 24561 / 25423 / 70
serious
Total, serious adverse events
6 / 3123 / 3114 / 10512 / 29213 / 2926 / 9016 / 24513 / 2546 / 70

Outcome results

Primary

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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16169 Participants
PlaceboNumber of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16123 Participants
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.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAPSA baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 8-13.5855 Score on a scaleStandard Deviation 14.33402
DeucravacitinibChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 12-15.7385 Score on a scaleStandard Deviation 16.02197
DeucravacitinibChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 16-17.5225 Score on a scaleStandard Deviation 16.66002
DeucravacitinibChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 2-4.9619 Score on a scaleStandard Deviation 12.27319
DeucravacitinibChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 4-9.0129 Score on a scaleStandard Deviation 11.93271
PlaceboChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 4-8.2813 Score on a scaleStandard Deviation 12.79788
PlaceboChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 8-10.7292 Score on a scaleStandard Deviation 16.10715
PlaceboChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 2-5.9569 Score on a scaleStandard Deviation 12.24097
PlaceboChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 12-11.8980 Score on a scaleStandard Deviation 16.33187
PlaceboChange From Baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA) ScoreWeek 16-12.1547 Score on a scaleStandard Deviation 17.74566
Comparison: Week 2p-value: 0.702595% CI: [-1.456, 2.1609]ANCOVA
Comparison: Week 4p-value: 0.141395% CI: [-3.2023, 0.4562]ANCOVA
Comparison: Week 8p-value: 0.000795% CI: [-5.9155, -1.589]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-7.0388, -2.5757]ANOVA
Comparison: Week 16p-value: <0.000195% CI: [-8.6082, -3.793]ANCOVA
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.

Time frame: Baseline, Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements

ArmMeasureValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16-1.3133 score on a scaleStandard Deviation 1.1742
PlaceboChange From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16-0.9095 score on a scaleStandard Deviation 1.1047
p-value: <0.000195% CI: [-0.6455, -0.3031]ANCOVA
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.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 2-0.3226 Score on a scaleStandard Deviation 0.74392
DeucravacitinibChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 12-1.1279 Score on a scaleStandard Deviation 1.14379
DeucravacitinibChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 16-1.3133 Score on a scaleStandard Deviation 1.1742
DeucravacitinibChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 4-0.6292 Score on a scaleStandard Deviation 0.84069
DeucravacitinibChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 8-0.9992 Score on a scaleStandard Deviation 1.0175
PlaceboChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 8-0.7579 Score on a scaleStandard Deviation 0.99991
PlaceboChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 2-0.4044 Score on a scaleStandard Deviation 0.70334
PlaceboChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 4-0.5888 Score on a scaleStandard Deviation 0.75652
PlaceboChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 16-0.9095 Score on a scaleStandard Deviation 1.1047
PlaceboChange From Baseline in Disease Activity Score (DAS) 28 C-reactive Protein (CRP) ScoreWeek 12-0.8826 Score on a scaleStandard Deviation 1.03604
Comparison: Week 2p-value: 0.570795% CI: [-0.0782, 0.1419]ANCOVA
Comparison: Week 4p-value: 0.186295% CI: [-0.2069, 0.0402]ANCOVA
Comparison: Week 8p-value: 0.000295% CI: [-0.4497, -0.1418]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-0.4889, -0.1635]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-0.6455, -0.3031]ANCOVA
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.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 41.3 Score on a scaleStandard Deviation 6.7
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 122.2 Score on a scaleStandard Deviation 8.4
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 82.9 Score on a scaleStandard Deviation 7.53
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 162.6 Score on a scaleStandard Deviation 8.17
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 20.8 Score on a scaleStandard Deviation 6.6
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 161.9 Score on a scaleStandard Deviation 8.54
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 21.5 Score on a scaleStandard Deviation 6.52
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 41.6 Score on a scaleStandard Deviation 6.95
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 81.9 Score on a scaleStandard Deviation 8.54
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) ScoreWeek 122.0 Score on a scaleStandard Deviation 8.91
Comparison: Week 2p-value: 0.192495% CI: [-1.6, 0.3]ANCOVA
Comparison: Week 4p-value: 0.760195% CI: [-1.2, 0.8]ANCOVA
Comparison: Week 8p-value: 0.030395% CI: [0.1, 2.4]ANCOVA
Comparison: Week 12p-value: 0.474795% CI: [-0.8, 1.7]ANCOVA
Comparison: Week 16p-value: 0.201795% CI: [-0.4, 2]ANCOVA
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.

Time frame: Baseline, Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements

ArmMeasureValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 162.6 Score on a scaleStandard Deviation 8.17
PlaceboChange From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 161.9 Score on a scaleStandard Deviation 8.54
p-value: 0.201795% CI: [-0.4, 2]ANCOVA
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.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 4-0.1547 score on a scaleStandard Deviation 0.41308
DeucravacitinibChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 12-0.2544 score on a scaleStandard Deviation 0.45565
DeucravacitinibChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 8-0.2301 score on a scaleStandard Deviation 0.44365
DeucravacitinibChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 16-0.3103 score on a scaleStandard Deviation 0.46159
DeucravacitinibChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 2-0.0546 score on a scaleStandard Deviation 0.38637
PlaceboChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 16-0.2219 score on a scaleStandard Deviation 0.46858
PlaceboChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 2-0.1335 score on a scaleStandard Deviation 0.34583
PlaceboChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 4-0.1760 score on a scaleStandard Deviation 0.40042
PlaceboChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 8-0.1964 score on a scaleStandard Deviation 0.43603
PlaceboChange From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI)Week 12-0.2236 score on a scaleStandard Deviation 0.46098
Comparison: Week 2p-value: 0.023195% CI: [0.0088, 0.1198]ANCOVA
Comparison: Week 4p-value: 0.786595% CI: [-0.0528, 0.0697]ANCOVA
Comparison: Week 8p-value: 0.12895% CI: [-0.1179, 0.0148]ANCOVA
Comparison: Week 12p-value: 0.11895% CI: [-0.1219, 0.0137]ANCOVA
Comparison: Week 16p-value: 0.001395% CI: [-0.1814, -0.0438]ANCOVA
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.

Time frame: Baseline, Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements

ArmMeasureValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16-0.3103 score on a scaleStandard Deviation 0.46159
PlaceboChange From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16-0.2219 score on a scaleStandard Deviation 0.46858
p-value: 0.001395% CI: [-0.1814, -0.0438]ANCOVA
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.

Time frame: Baseline, Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with mCPDAI baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 12-1.6 Score on a scaleStandard Deviation 1.8
DeucravacitinibChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 8-1.3 Score on a scaleStandard Deviation 1.71
DeucravacitinibChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 16-1.8 Score on a scaleStandard Deviation 1.97
DeucravacitinibChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 4-0.8 Score on a scaleStandard Deviation 1.57
PlaceboChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 16-1.2 Score on a scaleStandard Deviation 2.02
PlaceboChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 8-0.9 Score on a scaleStandard Deviation 1.86
PlaceboChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 12-1.0 Score on a scaleStandard Deviation 1.87
PlaceboChange From Baseline in Modified Composite Psoriatic Disease Activity Index (mCPDAI)Week 4-0.7 Score on a scaleStandard Deviation 1.76
Comparison: Week 4p-value: 0.214395% CI: [-0.4, 0.1]ANCOVA
Comparison: Week 8p-value: 0.000195% CI: [-0.8, -0.2]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-1, -0.4]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-0.9, -0.4]ANCOVA
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.

Time frame: Baseline, Weeks 4, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PROMIS baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 4-1.35 Score on a scaleStandard Deviation 6.958
DeucravacitinibChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 12-1.76 Score on a scaleStandard Deviation 7.945
DeucravacitinibChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 16-2.21 Score on a scaleStandard Deviation 7.447
PlaceboChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 4-1.41 Score on a scaleStandard Deviation 6.156
PlaceboChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 12-1.48 Score on a scaleStandard Deviation 7.145
PlaceboChange From Baseline in Patient-Reported Outcome Measures Information System (PROMIS)Week 16-1.53 Score on a scaleStandard Deviation 7.134
Comparison: Week 4p-value: 0.983495% CI: [-0.99, 0.97]ANCOVA
Comparison: Week 12p-value: 0.609995% CI: [-1.39, 0.82]ANCOVA
Comparison: Week 16p-value: 0.220595% CI: [-1.71, 0.4]ANCOVA
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.

Time frame: Baseline, Weeks 4, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with PASDAS baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 4-0.8037 Score on a scaleStandard Deviation 0.90993
DeucravacitinibChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 12-1.5273 Score on a scaleStandard Deviation 1.27441
DeucravacitinibChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 16-1.7047 Score on a scaleStandard Deviation 1.32902
PlaceboChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 4-0.7690 Score on a scaleStandard Deviation 0.90884
PlaceboChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 12-1.0137 Score on a scaleStandard Deviation 1.174
PlaceboChange From Baseline in Psoriatic Arthritis Disease Activity Score (PASDAS)Week 16-1.1434 Score on a scaleStandard Deviation 1.26434
Comparison: Week 4p-value: 0.283695% CI: [-0.2144, 0.0627]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-0.7396, -0.3699]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-0.7826, -0.3843]ANCOVA
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.

Time frame: Baseline, Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 2-0.658 Score on a scaleStandard Deviation 1.3895
DeucravacitinibChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 4-0.986 Score on a scaleStandard Deviation 1.5902
DeucravacitinibChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 12-1.511 Score on a scaleStandard Deviation 1.9314
DeucravacitinibChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 8-1.419 Score on a scaleStandard Deviation 1.7445
DeucravacitinibChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 16-1.729 Score on a scaleStandard Deviation 2.015
PlaceboChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 16-0.968 Score on a scaleStandard Deviation 1.9075
PlaceboChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 8-0.849 Score on a scaleStandard Deviation 1.8018
PlaceboChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 2-0.590 Score on a scaleStandard Deviation 1.2369
PlaceboChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 12-0.937 Score on a scaleStandard Deviation 1.9126
PlaceboChange From Baseline in Psoriatic Arthritis Impact of Disease (PsAID) 12 ScoreWeek 4-0.761 Score on a scaleStandard Deviation 1.5206
Comparison: Week 2p-value: 0.445995% CI: [-0.276, 0.122]ANCOVA
Comparison: Week 4p-value: 0.046195% CI: [-0.46, -0.004]ANCOVA
Comparison: Week 8p-value: <0.000195% CI: [-0.857, -0.339]ANCOVA
Comparison: Week 12p-value: <0.000195% CI: [-0.882, -0.327]ANCOVA
Comparison: Week 16p-value: <0.000195% CI: [-1.071, -0.501]ANCOVA
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.

Time frame: Baseline, Weeks 4, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 MCS baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 40.195 Score on a scaleStandard Deviation 7.7026
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 121.245 Score on a scaleStandard Deviation 8.6442
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 161.009 Score on a scaleStandard Deviation 9.774
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 16-0.438 Score on a scaleStandard Deviation 9.3388
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 40.300 Score on a scaleStandard Deviation 7.7067
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Mental Component Summary (MCS) ScoreWeek 120.123 Score on a scaleStandard Deviation 9.1804
Comparison: Week 4p-value: 0.615995% CI: [-1.396, 0.827]ANCOVA
Comparison: Week 12p-value: 0.184795% CI: [-0.396, 2.054]ANCOVA
Comparison: Week 16p-value: 0.088895% CI: [-0.174, 2.464]ANCOVA
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.

Time frame: Baseline, Weeks 4, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 43.364 Score on a scaleStandard Deviation 5.8439
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 125.419 Score on a scaleStandard Deviation 7.1066
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 166.194 Score on a scaleStandard Deviation 7.464
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 42.771 Score on a scaleStandard Deviation 5.8897
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 123.578 Score on a scaleStandard Deviation 6.7537
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) ScoreWeek 164.262 Score on a scaleStandard Deviation 7.0328
Comparison: Week 4p-value: 0.114795% CI: [-0.168, 1.551]ANCOVA
Comparison: Week 12p-value: 0.000195% CI: [0.991, 3.008]ANCOVA
Comparison: Week 16p-value: 0.000295% CI: [0.98, 3.105]ANCOVA
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.

Time frame: Baseline, Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements

ArmMeasureValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 166.194 Score on a scaleStandard Deviation 7.464
PlaceboChange From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 164.262 Score on a scaleStandard Deviation 7.0328
p-value: 0.000295% CI: [0.98, 3.105]ANCOVA
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.

Time frame: Baseline, Weeks 4, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with EQ-5D-5L baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Utility Score0.0990 Score on a scaleStandard Deviation 0.21113
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Utility Score0.0505 Score on a scaleStandard Deviation 0.17658
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Mobility-0.2 Score on a scaleStandard Deviation 0.74
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Mobility-0.3 Score on a scaleStandard Deviation 0.92
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Self-Care-0.1 Score on a scaleStandard Deviation 0.73
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Self-Care-0.2 Score on a scaleStandard Deviation 0.83
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Usual Activities-0.1 Score on a scaleStandard Deviation 0.76
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Usual Activities-0.3 Score on a scaleStandard Deviation 0.84
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Pain/Discomfort-0.3 Score on a scaleStandard Deviation 0.75
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Pain/Discomfort-0.5 Score on a scaleStandard Deviation 0.89
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Anxiety/Depression-0.1 Score on a scaleStandard Deviation 0.76
DeucravacitinibChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Anxiety/Depression-0.1 Score on a scaleStandard Deviation 0.77
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Anxiety/Depression-0.1 Score on a scaleStandard Deviation 0.78
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Utility Score0.0770 Score on a scaleStandard Deviation 0.22126
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Anxiety/Depression0.0 Score on a scaleStandard Deviation 0.88
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Usual Activities-0.2 Score on a scaleStandard Deviation 0.73
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Pain/Discomfort-0.4 Score on a scaleStandard Deviation 0.93
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Mobility-0.2 Score on a scaleStandard Deviation 0.76
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Usual Activities-0.3 Score on a scaleStandard Deviation 0.83
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Mobility-0.3 Score on a scaleStandard Deviation 0.87
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Utility Score0.0655 Score on a scaleStandard Deviation 0.1908
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Self-Care-0.2 Score on a scaleStandard Deviation 0.71
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 4 Pain/Discomfort-0.3 Score on a scaleStandard Deviation 0.8
PlaceboChange From Baseline in the European Quality of Life 5D-5L (EQ-5D-5L) Utility Scores and Its SubcomponentsWeek 16 Self-Care-0.2 Score on a scaleStandard Deviation 0.81
Comparison: Week 4 Utility Scorep-value: 0.848795% CI: [-0.0291, 0.0239]ANCOVA
Comparison: Week 16 Utility Scorep-value: 0.017195% CI: [0.0065, 0.0665]ANCOVA
Comparison: Week 4 Mobilityp-value: 0.925495% CI: [-0.1, 0.1]ANCOVA
Comparison: Week 16 Mobilityp-value: 0.056695% CI: [-0.2, 0]ANCOVA
Comparison: Week 4 Self-Carep-value: 0.893395% CI: [-0.1, 0.1]ANCOVA
Comparison: Week 16 Self-Carep-value: 0.073895% CI: [-0.2, 0]ANCOVA
Comparison: Week 4 Usual Activitiesp-value: 0.617695% CI: [-0.1, 0.1]ANCOVA
Comparison: Week 16 Usual Activitiesp-value: 0.154495% CI: [-0.2, 0]ANCOVA
Comparison: Week 4 Pain/Discomfortp-value: 0.470795% CI: [-0.2, 0.1]ANCOVA
Comparison: Week 16 Pain/Discomfortp-value: 0.011495% CI: [-0.3, 0]ANCOVA
Comparison: Week 4 Anxiety/Depressionp-value: 0.659495% CI: [-0.1, 0.1]ANCOVA
Comparison: Week 16 Anxiety/Depressionp-value: 0.712395% CI: [-0.1, 0.1]ANCOVA
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.

Time frame: Baseline, Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with WPAI baseline and post-baseline measurements

ArmMeasureGroupValue (MEAN)Dispersion
DeucravacitinibChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Presenteeism-13.97 Score on a scaleStandard Deviation 23.38
DeucravacitinibChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Activity Impairment-15.72 Score on a scaleStandard Deviation 25.226
DeucravacitinibChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Absenteeism-0.59 Score on a scaleStandard Deviation 21.406
DeucravacitinibChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Work Productivity-13.71 Score on a scaleStandard Deviation 24.087
PlaceboChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Activity Impairment-8.16 Score on a scaleStandard Deviation 24.178
PlaceboChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Presenteeism-5.96 Score on a scaleStandard Deviation 22.238
PlaceboChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Work Productivity-5.79 Score on a scaleStandard Deviation 23.951
PlaceboChange From Baseline in The Work Productivity and Activity Impairment (WPAI) at Week 16Absenteeism1.56 Score on a scaleStandard Deviation 22.108
Comparison: Absenteeismp-value: 0.831695% CI: [-3.91, 3.15]ANCOVA
Comparison: Presenteeismp-value: 0.10695% CI: [-6.54, 0.63]ANCOVA
Comparison: Work Productivityp-value: 0.157895% CI: [-6.47, 1.05]ANCOVA
Comparison: Activity Impairmentp-value: <0.000195% CI: [-10.96, -4.22]ANCOVA
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

Time frame: Weeks 2, 4, 8, 12, 16

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 46 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 1211 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 812 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 1617 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 22 Participants
PlaceboNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 164 Participants
PlaceboNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 21 Participants
PlaceboNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 41 Participants
PlaceboNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 85 Participants
PlaceboNumber of Participants Meeting Achievement of Improvement of Bath Ankylosing Spondylitis Disease Activity (BASDAI) ScoreWeek 124 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: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1

Time frame: Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 419 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 835 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 1256 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 1680 Participants
PlaceboNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 1646 Participants
PlaceboNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 416 Participants
PlaceboNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 1224 Participants
PlaceboNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA)Week 828 Participants
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: 1. Tender joint count ≤ 1 2. Swollen joint count ≤ 1 3. Psoriasis Area and Severity Index (PASI) ≤ 1 or body surface area (BSA) ≤ 3% 4. Patient assessment of psoriatic arthiritis (PsA) pain ≤ 15 5. Patient Global Assessment of PsA disease activity ≤ 20 6. HAQ-DI ≤ 0.5 7. Tender enthesial points ≤ 1

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 1680 Participants
PlaceboNumber of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 1646 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.

Time frame: Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with a baseline PGA-F score of \>= 3

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 410 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 813 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 1216 Participants
DeucravacitinibNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 1617 Participants
PlaceboNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 1615 Participants
PlaceboNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 410 Participants
PlaceboNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 1211 Participants
PlaceboNumber of Participants Meeting Achievement of Physician Global Assessment-Fingernails (PGA-F) of 0/1Week 813 Participants
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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting American College of Rheumatology (ACR) 50 at Week 1690 Participants
PlaceboNumber of Participants Meeting American College of Rheumatology (ACR) 50 at Week 1651 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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting American College of Rheumatology (ACR) 70 at Week 1633 Participants
PlaceboNumber of Participants Meeting American College of Rheumatology (ACR) 70 at Week 1617 Participants
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.

Time frame: Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Dactylitis ResolutionWeek 424 Participants
DeucravacitinibNumber of Participants Meeting Dactylitis ResolutionWeek 831 Participants
DeucravacitinibNumber of Participants Meeting Dactylitis ResolutionWeek 1239 Participants
DeucravacitinibNumber of Participants Meeting Dactylitis ResolutionWeek 1643 Participants
PlaceboNumber of Participants Meeting Dactylitis ResolutionWeek 1636 Participants
PlaceboNumber of Participants Meeting Dactylitis ResolutionWeek 430 Participants
PlaceboNumber of Participants Meeting Dactylitis ResolutionWeek 1229 Participants
PlaceboNumber of Participants Meeting Dactylitis ResolutionWeek 827 Participants
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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Dactylitis Resolution at Week 1643 Participants
PlaceboNumber of Participants Meeting Dactylitis Resolution at Week 1636 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.

Time frame: Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 445 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 870 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 1274 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 1674 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 1666 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 455 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 1258 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI)Week 854 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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 1674 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 1666 Participants
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.

Time frame: Weeks 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by SPARCC

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 453 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 873 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 1275 Participants
DeucravacitinibNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 1686 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 1675 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 455 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 1266 Participants
PlaceboNumber of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Spondyloarthritis Research Consortium of Canada (SPARCC)Week 855 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.

Time frame: Weeks 4, 8, 12, 16

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 42 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 86 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 1217 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 1624 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 168 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 40 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 129 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 100 (PASI 100)Week 83 Participants
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.

Time frame: Weeks 4, 8, 12, 16

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 414 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 826 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 1245 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 1663 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 1623 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 410 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 1222 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75)Week 819 Participants
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.

Time frame: Week 16

Population: 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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 1663 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 1623 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.

Time frame: Weeks 4, 8, 12, 16

Population: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 44 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 810 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 1231 Participants
DeucravacitinibNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 1641 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 1613 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 43 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 1215 Participants
PlaceboNumber of Participants Meeting Psoriasis Area and Severity Index 90 (PASI 90)Week 87 Participants
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.

Time frame: Week 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16131 Participants
PlaceboNumber of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16118 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.

Time frame: Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 1220 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 42 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 812 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 21 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 1630 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 21 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 84 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 169 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 41 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Disease RemissionWeek 128 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.

Time frame: Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 869 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 1295 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 444 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 16104 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 225 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 1678 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 218 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 855 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 442 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Index for Psoriatic Arthritis (DAPSA) Low Disease Activity ResponseWeek 1266 Participants
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.

Time frame: Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 1264 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 1684 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 213 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 427 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 857 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 831 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 414 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 1644 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 1235 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Disease RemissionWeek 27 Participants
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.

Time frame: Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 1656 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 439 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 835 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 1254 Participants
DeucravacitinibNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 223 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 1643 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 1239 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 431 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 219 Participants
PlaceboNumber of Participants With Achievement of Disease Activity Score (DAS) 28 C-reactive Protein (CRP) Low Disease Activity ResponseWeek 832 Participants
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

Time frame: Weeks 2, 4, 8, 12, 16

Population: All randomized participants of deucravacitinib and placebo as pre-specified in protocol

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
DeucravacitinibNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 12176 Participants
DeucravacitinibNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 16187 Participants
DeucravacitinibNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 271 Participants
DeucravacitinibNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 8163 Participants
DeucravacitinibNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 4128 Participants
PlaceboNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 498 Participants
PlaceboNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 12122 Participants
PlaceboNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 8126 Participants
PlaceboNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 16138 Participants
PlaceboNumber of Participants With Achievement of Psoriatic Arthritis Response Criteria (PsARC)Week 269 Participants

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026