Trial · NCT04908189
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
NCT04908189, Phase 3, Active not recruiting, Bristol-Myers Squibb; results first posted 2025-04-13
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 or Had Previously Received TNFα Inhibitor Treatment. Trials, record NCT04908189. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04908189
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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 or Had Previously Received TNFα Inhibitor Treatment
- NCT number
- NCT04908189
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 729 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Psoriatic Arthritis
- Interventions
- Deucravacitinib, Placebo, Apremilast
- First posted
- 2021-06-01
- Last updated
- 2026-09-11
- Other registries' IDs
- eudract:2020-005099-36
- Results first posted
- 2025-04-13
Source ClinicalTrials.gov
Registered outcomes38
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | 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. |
| Secondary | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Baseline, 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 Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | Baseline, 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 | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | 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. |
| Secondary | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | Baseline, 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. |
| Secondary | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | 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. |
| Secondary | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | 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 |
| Secondary | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | Baseline, 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 | Number of Participants Meeting Dactylitis Resolution at Week 16 | 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. |
| Secondary | Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | 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. |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 registered outcomesOutcomes38
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Baseline, Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with DAS28-CRP baseline and post-baseline measurements | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | Baseline, Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with HAQ-DI baseline and post-baseline measurements | score on a scale | MEAN |
| SECONDARY | Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | Week 16 | 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 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | Baseline, Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with SF-36 PCS baseline and post-baseline measurements | Score on a scale | MEAN |
| SECONDARY | Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with enthesitis at baseline by LEI | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score at Week 16 | Baseline, Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with FACIT-Fatigue baseline and post-baseline measurements | Score on a scale | MEAN |
| SECONDARY | Number of Participants Meeting Dactylitis Resolution at Week 16 | Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol with tender dactylitis count \>=1 at baseline | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | Week 16 | All randomized participants of deucravacitinib and placebo as pre-specified in protocol | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 outcomesResults by group262
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | Deucravacitinib | 169 | Participants | ||
| Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | Placebo | 123 | Participants | ||
| Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Deucravacitinib | -1.3133 | Standard Deviation 1.17420 | score on a scale | |
| Change From Baseline in Disease Activity Score 28 C-reactive Protein (DAS28-CRP) at Week 16 | Placebo | -0.9095 | Standard Deviation 1.10470 | score on a scale | |
| Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | Deucravacitinib | -0.3103 | Standard Deviation 0.46159 | score on a scale | |
| Change From Baseline in Health Assessment Quiestionnaire - Disability Index (HAQ-DI) at Week 16 | Placebo | -0.2219 | Standard Deviation 0.46858 | score on a scale | |
| Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | Deucravacitinib | 63 | Participants | ||
| Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | Placebo | 23 | Participants | ||
| Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | Deucravacitinib | 6.194 | Standard Deviation 7.4640 | Score on a scale | |
| Change From Baseline in the 36-item Short Form (SF-36) Physical Component Summary (PCS) Score at Week 16 | Placebo | 4.262 | Standard Deviation 7.0328 | Score on a scale |
1 to 10 of 262Source ClinicalTrials.gov
See all 262 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment | STARTED | Deucravacitinib | 312 | |
| Pre-treatment | STARTED | Placebo | 312 | |
| Pre-treatment | STARTED | Apremilast | 105 | |
| Pre-treatment | COMPLETED | Deucravacitinib | 312 | |
| Pre-treatment | COMPLETED | Placebo | 311 | |
| Pre-treatment | COMPLETED | Apremilast | 105 | |
| Pre-treatment | NOT COMPLETED | Deucravacitinib | 0 | |
| Pre-treatment | NOT COMPLETED | Placebo | 1 | |
| Pre-treatment | NOT COMPLETED | Apremilast | 0 | |
| Placebo-Controlled (Week 0 - Week 16) | STARTED | Deucravacitinib | 312 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events765
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 | Events |
|---|---|---|---|---|---|---|
| other | Diarrhoea | Gastrointestinal disorders | Deucravacitinib-Controlled | 11 | 312 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Controlled | 15 | 311 | |
| other | Diarrhoea | Gastrointestinal disorders | Apremilast-Controlled | 11 | 105 | |
| other | Diarrhoea | Gastrointestinal disorders | Deucravacitinib-Active Treatment | 10 | 292 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Active Treatment | 6 | 292 | |
| other | Diarrhoea | Gastrointestinal disorders | Apremilast-Active Treatment | 11 | 90 | |
| other | Diarrhoea | Gastrointestinal disorders | Deucravacitinib-Open Label Extension | 2 | 245 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo-Open Label Extension | 5 | 254 | |
| other | Diarrhoea | Gastrointestinal disorders | Apremilast-Open Label Extension | 3 | 70 | |
| other | Nausea | Gastrointestinal disorders | Deucravacitinib-Controlled | 7 | 312 |
1 to 10 of 765Source ClinicalTrials.gov
See all 765 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Deucravacitinib-Controlled | 0 | 312 |
| Total, all-cause mortality | Placebo-Controlled | 1 | 312 |
| Total, all-cause mortality | Apremilast-Controlled | 0 | 105 |
| Total, all-cause mortality | Deucravacitinib-Active Treatment | 0 | 292 |
| Total, all-cause mortality | Placebo-Active Treatment | 1 | 292 |
| Total, all-cause mortality | Apremilast-Active Treatment | 0 | 90 |
| Total, all-cause mortality | Deucravacitinib-Open Label Extension | 0 | 245 |
| Total, all-cause mortality | Placebo-Open Label Extension | 1 | 254 |
| Total, all-cause mortality | Apremilast-Open Label Extension | 0 | 70 |
| Total, other adverse events | Deucravacitinib-Controlled | 89 | 312 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers0
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Deucravacitinib vs Placebo: Number of Participants Meeting American College of Rheumatology (ACR) 20 at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Who Achieve a Clinically Meaningful Improvement in HAQ-DI Score at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting Enthesitis Resolution (Score of 0) Among Participants With Enthesitis at Baseline by Leeds Enthesitis Index (LEI) at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting Dactylitis Resolution at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting Psoriasis Area and Severity Index 75 (PASI 75) at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting American College of Rheumatology (ACR) 50 at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting American College of Rheumatology (ACR) 70 at Week 16 | Trial comparisons |
| Deucravacitinib vs Placebo: Number of Participants Meeting Achievement of Minimal Disease Activity (MDA) at Week 16 | Trial comparisons |
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.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04908189
GET https://conductscience.org/api/trials/v1/NCT04908189/registered?page=2