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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004461-40 | EudraCT Number | ||
| U1111-1258-3838 | Registry Identifier | WHO |
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The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate to severe Ulcerative Colitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Long-Term Extension Rollover Study: Deucravacitinib | Experimental |
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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 |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment | From first dose to 30 days post last dose (Up to 110 weeks) |
| Number of Participants With Laboratory Abnormalities | Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal. | From first dose to 30 days post last dose (Up to 110 weeks) |
| Number of Participants With Electrocardiogram (ECG) Abnormalities | From first dose to 30 days post last dose (Up to 110 weeks) | |
| Number of Participants With Vital Signs Abnormalities | From first dose to 30 days post last dose (Up to 110 weeks) | |
| Change From Baseline in Laboratory Parameters | Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function | Baseline, Week 12, Week 108 |
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Inclusion Criteria:
• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution - 0036 | Shreveport | Louisiana | 71105 | United States | ||
| Local Institution - 0002 |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Crohn's Disease | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) |
| FG001 | Ulcerative Colitis | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Pre-treatment |
|
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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 | Mar 4, 2022 |
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| Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate | Baseline, Week 48, Week 96 |
| Change From Baseline in Electrocardiogram (ECG) Parameters | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters | Baseline, Week 48, Week 96 |
| Change From Baseline in Vital Signs Parameters - Heart Rate | Changes from IM011077 study baseline in vital signs parameters - heart rate | Baseline, Week 12, Week 108 |
| Change From Baseline in Vital Signs Parameters | Changes from IM011077 study baseline in vital signs parameters | Baseline, Week 12, Week 108 |
| Wyoming |
| Michigan |
| 49519 |
| United States |
| Local Institution - 0037 | Jackson | Mississippi | 39216 | United States |
| Local Institution - 0041 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 0038 | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution - 0066 | Charleston | South Carolina | 29425 | United States |
| Local Institution - 0053 | Garland | Texas | 75044 | United States |
| Local Institution - 0056 | San Antonio | Texas | 78229 | United States |
| Local Institution - 0049 | Tyler | Texas | 75701 | United States |
| Local Institution - 0055 | Richmond | Virginia | 23249 | United States |
| Local Institution - 0013 | Ballarat | Victoria | 3350 | Australia |
| Local Institution - 0050 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution - 0030 | Guangzhou | Guangdong | 510080 | China |
| Local Institution - 0029 | Guangzhou | Guangdong | 510655 | China |
| Local Institution - 0012 | Kiel | 24105 | Germany |
| Local Institution - 0062 | Budapest | 1083 | Hungary |
| Local Institution - 0023 | Budapest | 1088 | Hungary |
| Humanitas | Rozzano | Lombardy | 20089 | Italy |
| Fondazione Irccs - Policlinico San Matteo | Pavia | 27100 | Italy |
| Local Institution - 0063 | Hirosaki | Aomori | 036-8545 | Japan |
| Local Institution - 0047 | Sagamihara | Kanagawa | 252-0375 | Japan |
| Local Institution - 0027 | Saga | Saga-ken | 8498501 | Japan |
| Local Institution - 0026 | Bunkyo-ku | Tokyo | 1138519 | Japan |
| Local Institution - 0044 | Minato-ku | Tokyo | 105-8471 | Japan |
| Local Institution - 0060 | Amsterdam | North Holland | 1105 AZ | Netherlands |
| Local Institution - 0046 | Nowy Targ | Lesser Poland Voivodeship | 34-400 | Poland |
| Local Institution - 0061 | Tychy | Silesian Voivodeship | 43-100 | Poland |
| Local Institution - 0022 | Bydgoszcz | 85-231 | Poland |
| Local Institution - 0003 | Bydgoszcz | 85-794 | Poland |
| Local Institution - 0001 | Krakow | 31-501 | Poland |
| Local Institution - 0028 | Sopot | 81-756 | Poland |
| Local Institution - 0025 | Szczecin | 71-434 | Poland |
| Local Institution - 0035 | Warsaw | 00-728 | Poland |
| Local Institution - 0048 | Warsaw | 02-798 | Poland |
| Local Institution - 0004 | Warsaw | 03-712 | Poland |
| Local Institution - 0018 | Wroclaw | 53-114 | Poland |
| Local Institution - 0054 | Santa Maria da Feira | 4520-211 | Portugal |
| Local Institution | Bucharest | 020125 | Romania |
| Local Institution | Irkutsk | 664033 | Russia |
| Local Institution | Saint Petersburg | 195257 | Russia |
| Local Institution - 0045 | Fuenlabrada | Madrid | 28942 | Spain |
| Local Institution - 0064 | Taipei | 10002 | Taiwan |
| Local Institution - 0034 | Morriston | SA6 6NL | United Kingdom |
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| COMPLETED | Completed=Treated |
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| NOT COMPLETED |
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| Treatment |
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| ID | Title | Description |
|---|---|---|
| BG000 | Crohn's Disease | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) |
| BG001 | Ulcerative Colitis | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) |
| 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 | Count of Participants | 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 | Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) | Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment | All treated participants | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 110 weeks) |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants With Laboratory Abnormalities | Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal. | All treated participants with laboratory measurements | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 110 weeks) |
|
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| Primary | Number of Participants With Electrocardiogram (ECG) Abnormalities | All treated participants with ECG measurements | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 110 weeks) |
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| Primary | Number of Participants With Vital Signs Abnormalities | All treated participants with vital signs measurements | Posted | Count of Participants | Participants | From first dose to 30 days post last dose (Up to 110 weeks) |
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| Primary | Change From Baseline in Laboratory Parameters | Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function | All treated participants with baseline and post baseline measurements at pre-specified time points | Posted | Mean | Standard Error | mg/dL | Baseline, Week 12, Week 108 |
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| Primary | Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate | All treated participants with baseline and post baseline measurements at pre-specified time points | Posted | Mean | Standard Deviation | beats/min | Baseline, Week 48, Week 96 |
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| ||||||||||||||||||||||||||||||||||||
| Primary | Change From Baseline in Electrocardiogram (ECG) Parameters | Changes from IM011077 study baseline in electrocardiogram (ECG) parameters | All treated participants with baseline and post baseline measurements at pre-specified time points | Posted | Mean | Standard Deviation | msec | Baseline, Week 48, Week 96 |
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| Primary | Change From Baseline in Vital Signs Parameters - Heart Rate | Changes from IM011077 study baseline in vital signs parameters - heart rate | All treated participants with baseline and post baseline measurements at pre-specified time points | Posted | Mean | Standard Deviation | beats/min | Baseline, Week 12, Week 108 |
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| Primary | Change From Baseline in Vital Signs Parameters | Changes from IM011077 study baseline in vital signs parameters | All treated participants with baseline and post baseline measurements at pre-specified time points | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 12, Week 108 |
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SAEs and AEs are assessed from first dose to 30 days post last dose (Up to 110 weeks). Participants were assessed for all-cause mortality from their first dose to study completion (Up to 120 weeks).
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
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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 | CROHN'S DISEASE | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) | 0 | 26 | 2 | 24 | 12 | 24 |
| EG001 | ULCERATIVE COLITIS | Deucravacitinib (BMS-986165) 6 mg twice daily (BID) | 0 | 41 | 2 | 41 | 13 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure chronic | Cardiac disorders | MedDRA 26.0 | Systematic Assessment |
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| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| General physical health deterioration | General disorders | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Procedural pneumothorax | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Tonsillitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | 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 |
| Aug 28, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
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| Withdrawal by Subject |
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| Adverse Event |
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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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| Black or African American |
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| Asian |
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| American Indian or Alaska Native |
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| Native Hawaiian or Other Pacific Islander |
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| Other |
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| Asian Indian |
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| Chinese |
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| Japanese |
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| Asian Other |
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| TEAEs leading to study discontinuation |
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| AEs of Interest - Skin-related events |
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| AEs of Interest - Creatine Kinase events |
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