Trial · NCT04908202

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

NCT04908202, Phase 3, Active not recruiting, Bristol-Myers Squibb; results first posted 2025-10-24

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. 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. Trials, record NCT04908202. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04908202

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Study to Determine the Efficacy and Safety of Deucravacitinib Compared With Placebo in Participants With Active Psoriatic Arthritis (PsA) Who Are Naïve to Biologic Disease-modifying Anti-rheumatic Drugs
NCT number: NCT04908202
Status: Active not recruiting
Phases: Phase 3
Enrollment: 670 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Psoriatic Arthritis
Interventions: Deucravacitinib, Placebo
First posted: 2021-06-01
Last updated: 2026-10-16
Results first posted: 2025-10-24

Source ClinicalTrials.gov

Registered outcomes59

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of Participants With ACR 20 Response at Week 16	Week 16	The ACR 20 definition of improvement is a 20% improvement over baseline in tender and swollen joint counts (#1 and #2) and a 20% improvement in 3 of the 5 remaining core data set measures (Participant global assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, participant assessment of physical function, and acute phase reactant value). Baseline value is the last assessment taken prior to first dose of single-blind study medication. The 95% CI is calculated using Clopper-Pearson exact method.
Secondary	Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16	Baseline and 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.
Secondary	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16	Baseline and 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.
Secondary	Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline	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. The 95% CI is calculated using Clopper-Pearson exact method.
Secondary	Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16	Baseline and Week 16	SF-36 is a generic 36-item questionnaire measuring health-related quality of life. The physical subcomponent 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.
Secondary	Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16	Week 16	Percentage 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.
Secondary	Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16	Week 16	Percentage of 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
Secondary	Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16	Baseline and 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.
Secondary	Percentage of Participants Meeting Dactylitis Resolution at Week 16	Week 16	Percentage 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.
Secondary	Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16	Baseline and Week 16	The PsA-modified Sharp-van der Heijde (SvdH) score is a radiographic tool used to assess structural joint damage in psoriatic arthritis. It evaluates erosions, joint space narrowing, (sub)luxation, and ankylosis in 52 joints of the hands and feet, including distal interphalangeal joints. Erosions are scored 0-3 and joint space narrowing 0-4. The total score ranges from 0 to 528 (erosions: max 320; joint space narrowing: max 208). Higher scores indicate greater joint damage. Change from baseline reflects progression or improvement; a decrease suggests reduced damage or improvement.

1 to 10 of 59Source ClinicalTrials.gov

See all 59 registered outcomes

Outcomes59

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percentage of Participants With ACR 20 Response at Week 16	Week 16	Randomized population	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16	Baseline and Week 16	Randomized population. Only participants with data available at the timepoint were analyzed.	Score on a Scale	MEAN
SECONDARY	Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16	Baseline and Week 16	Randomized population. Only participants with data available at the timepoint were analyzed.	Score on a Scale	MEAN
SECONDARY	Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline	Week 16	Randomized population with participants with at least 3% body surface area (BSA) Involvement and at least static Physician's Global Assessment (sPGA) 2 at baseline	percentage of participants	NUMBER
SECONDARY	Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16	Baseline and Week 16	Randomized population. Only participants with data available at the timepoint were analyzed.	Score on a Scale	MEAN
SECONDARY	Percentage of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16	Week 16	Randomized population with Enthesitis at Baseline by LEI	percentage of participants	NUMBER
SECONDARY	Percentage of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16	Week 16	Randomized population. Only participants with available data at the timepoint were analyzed.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16	Baseline and Week 16	Randomized population. Only participants with data available at the timepoint were analyzed.	Score on a Scale	MEAN
SECONDARY	Percentage of Participants Meeting Dactylitis Resolution at Week 16	Week 16	Randomized population. Only participants with tender dactylitis count \>=1 at baseline were included in the analysis.	percentage of participants	NUMBER
SECONDARY	Change From Baseline in PsA-modified Sharp-van Der Heijde (SvdH) Score at Week 16	Baseline and Week 16	Randomized population. Only participants with data available at the timepoint were analyzed.	Score on a Scale	MEAN

1 to 10 of 59Source ClinicalTrials.gov

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Results by group368

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percentage of Participants With ACR 20 Response at Week 16	Placebo-Controlled Period - Deucravacitinib 6 mg QD	54.2	95% Confidence Interval 48.7 to 59.6	percentage of participants
Percentage of Participants With ACR 20 Response at Week 16	Placebo-Controlled Period - Placebo	34.1	95% Confidence Interval 29.1 to 39.5	percentage of participants
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16	Placebo-Controlled Period - Deucravacitinib 6 mg QD	-1.4106	Standard Deviation 1.13277	Score on a Scale
Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16	Placebo-Controlled Period - Placebo	-0.8902	Standard Deviation 1.10750	Score on a Scale
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16	Placebo-Controlled Period - Deucravacitinib 6 mg QD	-0.4103	Standard Deviation 0.52303	Score on a Scale
Change From Baseline in Health Assessment Questionnaire - Disability Index (HAQ-DI) at Week 16	Placebo-Controlled Period - Placebo	-0.2118	Standard Deviation 0.51583	Score on a Scale
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline	Placebo-Controlled Period - Deucravacitinib 6 mg QD	51.9	95% Confidence Interval 43.9 to 59.8	percentage of participants
Percentage of Participants Meeting Psoriatic Area and Severity Index (PASI) 75 Response at Week 16, in Participants With at Least 3% Body Surface Area (BSA) Involvement and at Least Static Physician's Global Assessment (sPGA) 2 at Baseline	Placebo-Controlled Period - Placebo	7.1	95% Confidence Interval 3.7 to 12.0	percentage of participants
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16	Placebo-Controlled Period - Deucravacitinib 6 mg QD	6.410	Standard Deviation 8.2883	Score on a Scale
Change From Baseline in the 36-item Short Form (SF-36) Physical Subcomponent Summary (PCS) Score at Week 16	Placebo-Controlled Period - Placebo	3.847	Standard Deviation 7.2929	Score on a Scale

1 to 10 of 368Source ClinicalTrials.gov

See all 368 results by group

Participant flow36

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment Period	STARTED	Placebo-Controlled Period - Deucravacitinib 6 mg QD	336
Pre-Treatment Period	STARTED	Placebo-Controlled Period - Placebo	334
Pre-Treatment Period	STARTED	Active Treatment Period - Deucravacitinib 6 mg QD	0
Pre-Treatment Period	STARTED	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	0
Pre-Treatment Period	COMPLETED	Placebo-Controlled Period - Deucravacitinib 6 mg QD	332
Pre-Treatment Period	COMPLETED	Placebo-Controlled Period - Placebo	333
Pre-Treatment Period	COMPLETED	Active Treatment Period - Deucravacitinib 6 mg QD	0
Pre-Treatment Period	COMPLETED	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	0
Pre-Treatment Period	NOT COMPLETED	Placebo-Controlled Period - Deucravacitinib 6 mg QD	4
Pre-Treatment Period	NOT COMPLETED	Placebo-Controlled Period - Placebo	1

1 to 10 of 36Source ClinicalTrials.gov

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Adverse events216

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Nasopharyngitis	Infections and infestations	Placebo-Controlled Period - Deucravacitinib 6 mg QD	13	332
other	Nasopharyngitis	Infections and infestations	Placebo-Controlled Period - Placebo	12	333
other	Nasopharyngitis	Infections and infestations	Active Treatment Period - Deucravacitinib 6 mg QD	24	309
other	Nasopharyngitis	Infections and infestations	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	26	306
other	Upper respiratory tract infection	Infections and infestations	Placebo-Controlled Period - Deucravacitinib 6 mg QD	17	332
other	Upper respiratory tract infection	Infections and infestations	Placebo-Controlled Period - Placebo	10	333
other	Upper respiratory tract infection	Infections and infestations	Active Treatment Period - Deucravacitinib 6 mg QD	32	309
other	Upper respiratory tract infection	Infections and infestations	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	33	306
other	Hypertension	Vascular disorders	Placebo-Controlled Period - Deucravacitinib 6 mg QD	10	332
other	Hypertension	Vascular disorders	Placebo-Controlled Period - Placebo	10	333

1 to 10 of 216Source ClinicalTrials.gov

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Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo-Controlled Period - Deucravacitinib 6 mg QD	0	336
Total, all-cause mortality	Placebo-Controlled Period - Placebo	0	334
Total, all-cause mortality	Active Treatment Period - Deucravacitinib 6 mg QD	0	309
Total, all-cause mortality	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	0	306
Total, other adverse events	Placebo-Controlled Period - Deucravacitinib 6 mg QD	39	332
Total, other adverse events	Placebo-Controlled Period - Placebo	32	333
Total, other adverse events	Active Treatment Period - Deucravacitinib 6 mg QD	68	309
Total, other adverse events	Active-Treatment Period - Placebo-Deucravacitinib 6 mg QD	67	306
Total, serious adverse events	Placebo-Controlled Period - Deucravacitinib 6 mg QD	6	332
Total, serious adverse events	Placebo-Controlled Period - Placebo	8	333

1 to 10 of 12Source ClinicalTrials.gov

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Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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