Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1276-5158 | Registry Identifier | WHO |
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to evaluate the effect of deucravacitinib on quality of life (QoL) in participants with plaque psoriasis in a community setting.
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib | Experimental |
| |
| Placebo then Deucravacitinib | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all
| At Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all
|
Not provided
Inclusion Criteria
Exclusion Criteria:
Target Disease Exceptions:
Other protocol-defined inclusion/exclusion criteria apply.
Not provided
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0006 | Phoenix | Arizona | 85006 | United States | ||
| Local Institution - 0034 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol-Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
See Plan Description
See Plan Description
A total of 180 participants were randomized and of these 178 received at least one dose of study treatment.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Deucravacitinib | Deucravacitinib 6 mg daily (QD) |
| FG001 | Placebo | Placebo matching Deucravacitinib daily (QD) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-Treatment |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 25, 2023 |
Not provided
Not provided
Not provided
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| Placebo | Other | Specified dose on specified days. |
|
| At Week 16 |
| Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching. | Baseline and at Week 16 |
| Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16 | The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis. | At Week 16 |
| Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16 | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | From Week 0 through Week 16 |
| Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16 | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | From Week 0 through Week 16 |
| Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal | From Week 0 through Week 16 |
| Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening. | From Week 0 through Week 16 |
| Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. | From Week 0 through Week 16 |
| Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16 | Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern. | From Week 0 through Week 16 |
| Scottsdale |
| Arizona |
| 85260 |
| United States |
| Local Institution - 0015 | North Little Rock | Arkansas | 72117 | United States |
| Local Institution - 0004 | Bakersfield | California | 93309 | United States |
| Local Institution - 0009 | Sacramento | California | 95815 | United States |
| Local Institution - 0022 | San Diego | California | 92103 | United States |
| Local Institution - 0030 | Centennial | Colorado | 80111 | United States |
| Local Institution - 0024 | Washington D.C. | District of Columbia | 20016 | United States |
| Local Institution - 0027 | Brandon | Florida | 33511 | United States |
| Local Institution - 0016 | Coral Gables | Florida | 33134 | United States |
| Riverchase Dermatology | Pembroke Pines | Florida | 33028 | United States |
| Local Institution - 0037 | Atlanta | Georgia | 30331 | United States |
| Local Institution - 0020 | Snellville | Georgia | 30078 | United States |
| Local Institution - 0007 | Rolling Meadows | Illinois | 60008 | United States |
| Local Institution - 0025 | Skokie | Illinois | 60077 | United States |
| Local Institution - 0036 | Springfield | Illinois | 62703 | United States |
| Local Institution - 0003 | Baton Rouge | Louisiana | 70809 | United States |
| Local Institution - 0018 | Rockville | Maryland | 20850 | United States |
| Local Institution - 0010 | Auburn Hills | Michigan | 48326 | United States |
| Local Institution - 0002 | Waterford | Michigan | 48328 | United States |
| Local Institution - 0017 | Las Vegas | Nevada | 89148 | United States |
| Local Institution - 0035 | Reno | Nevada | 89509 | United States |
| Local Institution - 0032 | New York | New York | 10011 | United States |
| Local Institution - 0013 | New York | New York | 10128 | United States |
| Local Institution - 0001 | Rochester | New York | 14623 | United States |
| Local Institution - 0005 | Bexley | Ohio | 43209 | United States |
| Local Institution - 0012 | Mayfield Heights | Ohio | 44124 | United States |
| Local Institution - 0019 | Charleston | South Carolina | 29407 | United States |
| Local Institution - 0029 | Cypress | Texas | 77433 | United States |
| Local Institution - 0028 | Frisco | Texas | 75034 | United States |
| Local Institution - 0008 | South Jordan | Utah | 84095 | United States |
| Local Institution - 0033 | Springville | Utah | 84663 | United States |
| Local Institution - 0021 | Bellevue | Washington | 98004 | United States |
| Local Institution - 0031 | Mill Creek | Washington | 98012 | United States |
| Local Institution - 0014 | Spokane | Washington | 99202 | United States |
| Local Institution - 0040 | Caguas | 00727 | Puerto Rico |
| Local Institution - 0038 | Carolina | 00985 | Puerto Rico |
| Local Institution - 0039 | San Juan | 00917 | Puerto Rico |
|
| Full Analysis Set Sub-population | All participants who were randomized to any treatment group with baseline static physician global assessment (s-PGA) >=3 |
|
| COMPLETED | Completed = Treated |
|
| NOT COMPLETED |
|
|
| Placebo Controlled: Week 0-16 |
|
|
| Active Treatment: Week 16-52 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Deucravacitinib | Deucravacitinib 6 mg daily (QD) |
| BG001 | Placebo | Placebo matching Deucravacitinib daily (QD) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Score of 0 or 1 at Week 16 | Dermatology Life Quality Index (DLQI) is a participant-reported Quality of Life (QoL) survey which consists of 10 questions concerning symptoms and feelings, daily activities, leisure, work, school, personal relationships, and treatment during the last week. Each question is scored on a 4-point scale: 0=not at all
| Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3) | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 16 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants Achieving a ≥ 4-point Reduction From Baseline in Dermatology Life Quality Index (DLQI) at Week 16 | The Dermatology Life Quality Index (DLQI) is a simple, 10-question survey used to measure the impact of skin conditions on a patient's quality of life. It assesses how much a skin condition affects various aspects of daily life, including symptoms, feelings, daily activities, work or school, personal relationships, and treatment. The DLQI is scored by summing the responses to its 10 questions. Each question is scored on a scale from 0 to 3: 0 = Not at all
| Full Analysis Set: All Randomized Participants Full Analysis Set Sub-Population: All Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3) | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Whole-body Itch Numerical Rating Scale (NRS) Score at Week 16 | The whole-body itch Numerical Rating Scale (NRS) is a survey that participants fill out themselves. It uses an 11-point scale from 0 to 10, where 0 means 'no itch' and 10 means 'worst itch imaginable.' Participants indicate the severity of their itching from psoriasis by selecting the number that best describes the worst level of itching they experienced in the past 24 hours. A lower score means better outcomes, indicating less severe itching. | Full Analysis Set: Randomized Participants Full Analysis Set Sub-Population: Randomized Participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3) | Posted | Mean | Standard Deviation | Score on a Scale | Baseline and at Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With a Static Physician's Global Assessment (s-PGA) Score of 0 (Clear) or 1 (Almost Clear) With at Least a 2-point Reduction From Baseline at Week 16 | The Static Physician's Global Assessment (s-PGA) is a 5-point scale to evaluate the average severity of all psoriatic lesions based on redness, scaling, and thickness. The s-PGA measures psoriasis severity at a single point in time, without considering the initial condition. The scale rates the severity as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). A lower score means better outcomes, indicating less severe psoriasis. | All randomized participants with baseline static Physician Global Assessment ≥3 (s-PGA≥3) | Posted | Number | 95% Confidence Interval | Percentage of Participants | At Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) From Week 0 to Week 16 | An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Serious Adverse Events (SAEs) From Week 0 to Week 16 | Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization. | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests From Week 0 to Week 16 | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=Alanine aminotransferase AST=Aspartate aminotransferase ULN=Upper limit of normal | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade 3/ Grade 4 Laboratory Abnormalities From Week 0 to Week 16 | Blood samples were collected to assess the abnormalities in laboratory parameters. The laboratory parameters were graded by Common Terminology Criteria for Adverse Events (CTCAE). Grade 3=Severe; Grade 4=Life-threatening. | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Abnormalities in Vital Signs From Week 0 to Week 16 | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Clinically Significant Changes in Vital Signs From Week 0 to Week 16 | Vital Sign Measurements include: Body Temperature (C), Respiratory Rate (breaths/min), Seated Blood Pressure (mmHg) and Heart Rate (beats/min). Clinically significant changes in these measurements may need medical attention as they could indicate a potential health concern. | As-treated Population | Posted | Count of Participants | Participants | From Week 0 through Week 16 |
|
|
Participants were assessed for All-cause mortality, Serious adverse events and Other adverse events for up to approximately 28 months.
All-cause mortality, serious adverse events (SAEs) and other adverse events were assessed in all-treated participants.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Controlled - Deucravacitinib | Deucravacitinib 6 mg daily (QD) | 1 | 119 | 3 | 119 | 32 | 119 |
| EG001 | Placebo Controlled - Placebo | Placebo matching Deucravacitinib daily (QD) | 0 | 59 | 1 | 59 | 13 | 59 |
| EG002 | Active Treatment - Deucravacitinib - Deucravacitinib | Deucravacitinib 6 mg daily (QD) | 1 | 103 | 5 | 103 | 26 | 103 |
| EG003 | Active Treatment - Placebo - Deucravacitinib | Deucravacitinib 6 mg daily (QD) | 0 | 49 | 3 | 49 | 10 | 49 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Vertigo positional | Ear and labyrinth disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Death | General disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Postoperative wound infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 28.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 28.0 | Systematic Assessment |
|
Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please email | Clinical.Trials@bms.com |
| Aug 1, 2025 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided
| Adverse Event |
|
| Other Reason |
|
| Death |
|
| Physician Decision |
|
| Lack of Efficacy |
|
| Adverse Event |
|
| Death |
|
| Other Reasons |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| Unknown or Not Reported |
|
| Full Analysis Set Sub-population |
|
|
| 0.0003 |
| Odds Ratio (OR) |
| 8.5 |
| 2-Sided |
| 95 |
| 2.4 |
| 30.4 |
| Superiority |
| Participants |
|
|
|
|
|
|
|
|
|
|
|
|
|