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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000797-26 | EudraCT Number | ||
| U1111-1274-7417 | Registry Identifier | WHO |
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The purpose of this study is to compare the efficacy and safety of deucravacitinib to placebo in participants with moderate-to-severe scalp psoriasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deucravacitinib | Experimental |
| |
| Placebo then Deucravacitinib | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deucravacitinib | Drug | Specified dose on specified days |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. | Baseline and Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms. |
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Inclusion Criteria:
Exclusion Criteria:
Target Disease Exceptions:
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0001 | Hot Springs | Arkansas | 71913 | United States | ||
| Local Institution - 0007 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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154 randomized and treated
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| ID | Title | Description |
|---|---|---|
| FG000 | Deucravacitinib | Deucravacitinib 6 mg daily (QD) |
| FG001 | Placebo | Placebo matching Deucravacitinib daily (QD) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Placebo Controlled: Week 0 - 16 |
|
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| 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 23, 2023 |
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| Placebo | Other | Specified dose on specified days |
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| Baseline and Week 16 |
| Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable.". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours. | Baseline and Week 16 |
| Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 | s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). | Baseline and Week 16 |
| Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 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 relation with this treatment. | From week 0 through week 16 |
| Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. | From week 0 through week 16 |
| Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization. | Week 0 through Week 16 |
| Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal | Week 0 through Week 16 |
| Number of Participants With Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. | Week 0 through Week 16 |
| Indianapolis |
| Indiana |
| 46256 |
| United States |
| Local Institution - 0041 | Louisville | Kentucky | 40217 | United States |
| Local Institution - 0022 | Rockville | Maryland | 20850 | United States |
| Local Institution - 0008 | Beverly | Massachusetts | 01915 | United States |
| Local Institution - 0047 | Bloomfield Hills | Michigan | 48302 | United States |
| Local Institution - 0002 | New Brighton | Minnesota | 55432 | United States |
| Local Institution - 0049 | East Windsor | New Jersey | 08520 | United States |
| Local Institution - 0051 | Kew Gardens | New York | 11415 | United States |
| Local Institution - 0003 | Portland | Oregon | 97201 | United States |
| Local Institution - 0005 | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution - 0033 | Houston | Texas | 77004 | United States |
| Local Institution - 0004 | San Antonio | Texas | 78229 | United States |
| Local Institution - 0006 | Norfolk | Virginia | 23502 | United States |
| Local Institution - 0019 | Paris | 75010 | France |
| Local Institution - 0040 | Romans-sur-Isère | 26102 | France |
| Local Institution - 0044 | Rouen | 76031 | France |
| Local Institution - 0038 | Witten | Deutschland | 58454 | Germany |
| Local Institution - 0013 | Frankfurt am Main | Hesse | 60590 | Germany |
| Local Institution - 0048 | Hamburg | 20246 | Germany |
| Local Institution - 0012 | Lübeck | 23538 | Germany |
| Local Institution - 0011 | Mahlow | 15831 | Germany |
| Local Institution - 0026 | Krakow | 30438 | Poland |
| Local Institution - 0017 | Lodz | 90-436 | Poland |
| Local Institution - 0014 | Rzeszów | 35-055 | Poland |
| Local Institution - 0015 | Wroclaw | 51-685 | Poland |
| Local Institution - 0031 | London | Greater London | SE1 9RT | United Kingdom |
| Local Institution - 0045 | Salford | Greater Manchester | M6 8HD | United Kingdom |
| Local Institution - 0039 | Southampton | HAMPSHIRE | SO16 6DU | United Kingdom |
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| COMPLETED |
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| NOT COMPLETED |
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| Active Treatment: Week 16 - Week 52 |
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| 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 |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | Participants |
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| 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 With a Scalp-specific Physician Global Assessment Score of 0 or 1 (Ss-PGA 0/1) at Week 16 | ss-PGA 0/1 response as a percentage of participants with an ss-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. Scalp lesions are evaluated in terms of clinical signs of redness, thickness, and scaliness and scored on the following 5-point ss-PGA scale: 0 = absence of disease, 1 = very mild disease, 2 = mild disease, 3 = moderate disease, 4 = severe disease. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of responders | Baseline and Week 16 |
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| Secondary | Percentage of Participants With a Psoriasis Scalp Severity Index 90 (PSSI 90) at Week 16 | PSSI 90 response as a percentage of participants who achieve at least 90% improvement from baseline in the PSSI score at Week 16. PSSI assesses severity of scalp disease in participants with scalp involvement with a 5-point Likert-type scale on the clinical parameters of erythema, induration, and desquamation. The scores are summed and multiplied by an integer (0 to 6) that represents the area of affected scalp. The PSSI score ranges from 0 to 72 with higher scores indicating more severe symptoms. | All randomized participants | Posted | Number | 95% Confidence Interval | Percentage of responders | Baseline and Week 16 |
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| Secondary | Change From Baseline in Scalp-specific Itch Numerical Rating Scale (NRS) Score at Week 16 | Change from baseline in scalp-specific itch numerical rating scale (NRS) score at week 16. The scalp-specific itch NRS is an 11-point horizontal scale anchored at 0 and 10 with 0 representing "no scalp itch" and 10 representing "worst scalp itch imaginable.". Overall severity of a participant's itching from scalp psoriasis is indicated by selecting the number that best describes the worst level of scalp itching within the past 24 hours. | All randomized participants | Posted | Mean | Standard Deviation | Score on a scale | Baseline and Week 16 |
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| Secondary | Percentage of Participants With a Static Physician Global Assessment Score of 0 or 1 (s-PGA 0/1) at Week 16 | s-PGA 0/1 response as a percentage of participants with an s-PGA score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline at Week 16. The s-PGA is a 5-point scale of an average assessment of all psoriatic lesions based on erythema, scale, and induration. The s-PGA measure determines psoriasis severity at a single point in time (without taking into account the baseline disease condition) as clear (0), almost clear (1), mild (2), moderate (3), or severe (4). | All randomized participants with a s-PGA ≥ 3 at baseline | Posted | Number | 95% Confidence Interval | Percentage of responders | Baseline and Week 16 |
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| Secondary | Number of Participants Experiencing Treatment Emergent Adverse Events (TEAEs) | 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 relation with this treatment. | All treated participants | Posted | Count of Participants | Participants | From week 0 through week 16 |
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| Secondary | Number of Participants Experiencing Serious Treatment Emergent Adverse Events (TEAEs) | A Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization. | All treated participants | Posted | Count of Participants | Participants | From week 0 through week 16 |
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| Secondary | Number of Participants Experiencing Laboratory Test Results of Worst Toxicity Grade | Laboratory test results summary of Worst toxicity grade in SI units for hematology and chemistry using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Grade 1= mild and asymptomatic; Grade 2= moderate requiring minimal, local or noninvasive intervention; Grade 3= severe or medically significant but not immediately life-threatening; Grade 4= events are usually severe enough to require hospitalization. | All treated participants with baseline and post-baseline laboratory assessments | Posted | Count of Participants | Participants | Week 0 through Week 16 |
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| Secondary | Number of Participants Experiencing Laboratory Abnormalities in Potential Drug-Induced Liver Injury Tests | Number of participants with laboratory abnormalities in potential drug-induced liver injury tests. ALT=alanine aminotransferase AST=aspartate aminotransferase ULN=upper limit of normal | All treated participants | Posted | Count of Participants | Participants | Week 0 through Week 16 |
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| Secondary | Number of Participants With Abnormalities in Vital Signs | Number of participants with abnormalities in vital signs including heart rate, systolic blood pressure, and diastolic blood pressure. | All treated participants | Posted | Count of Participants | Participants | Week 0 through Week 16 |
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Participants were assessed for all-cause mortality from their first dose to their primary data cut-off (Up to 24 months). SAEs and Other AEs were assessed from first dose up to 30 days post last dose (Up to 13 months).
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| 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) | 0 | 103 | 1 | 103 | 47 | 103 |
| EG001 | Placebo Controlled - Placebo | Placebo matching Deucravacitinib daily (QD) | 0 | 51 | 1 | 51 | 14 | 51 |
| EG002 | Active Treatment - Deucravacitinib - Deucravacitinib | Deucravacitinib 6 mg daily (QD) | 1 | 94 | 4 | 94 | 42 | 94 |
| EG003 | Active Treatment - Placebo - Deucravacitinib | Deucravacitinib 6 mg daily (QD) | 0 | 45 | 0 | 45 | 16 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 27.1 | Systematic Assessment |
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| Meniscus injury | Injury, poisoning and procedural complications | MedDRA 27.1 | Systematic Assessment |
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| Ligament disorder | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Colorectal adenocarcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | Systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acne pustular | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 27.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 27.1 | Systematic Assessment |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 27.1 | Systematic Assessment |
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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 |
| Jan 10, 2025 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Adverse Event |
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| Lost to Follow-up |
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| Death |
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| Non-compliance with protocol |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Black or African American |
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| Native Hawaiian or other pacific islander |
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| White |
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| Other |
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| Patient sub-population (s-PGA ≥ 3) |
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| Cochran-Mantel-Haenszel |
| <0.0001 |
| Odds Ratio (OR) |
| 7.0 |
| 2-Sided |
| 95 |
| 2.7 |
| 18.4 |
Cochran-Mantel-Haenszel |
| Superiority |
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