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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-004878-26 | EudraCT Number | ||
| U1111-1245-2970 | Other Identifier | World Health Organization |
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The purpose of this study is to assess the safety and tolerability, efficacy, and biomarker response of BMS-986165 administered orally in participants with moderate to severe ulcerative colitis. The study was originally designed to test deucravacitinib at two doses for 12 weeks compared to placebo. After the initial 12-Week period, all subjects receive active therapy (open-label extension). With protocol amendment 2, one of the dose treatment arms is being removed from the 12-week double blind period with no change to the open-label extension.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Open label Extension, BMS-986165 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified Dose on Specified Days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Clinical Response at Week 12 | Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment)
Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components:
| At week 12 |
| Number of Participants Experiencing Adverse Events (AEs) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. | From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| Number of Participants Experiencing Serious Adverse Events (SAEs) | An 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, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. |
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Inclusion Criteria:
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 - 0014 | San Diego | California | 92123 | United States | ||
| Local Institution - 0036 |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
Not provided
BMS-986165 6 mg BID arm was removed under Protocol Amendment 02.
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| ID | Title | Description |
|---|---|---|
| FG000 | BMS-986165 12 mg BID | Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO. |
| FG001 | BMS-986165 6 mg BID |
| Title | Milestones | Reasons Not Completed | ||||
|---|---|---|---|---|---|---|
| Double-Blind Treatment Period |
|
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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 | Feb 24, 2022 |
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| Placebo Comparator | Other | Specified Dose on Specified Days |
|
| From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. | From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| Number of Participants Experiencing Adverse Events of Special Interest (AEIs) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19. | From first dose to 52 weeks after first dose |
| Arlington Heights |
| Illinois |
| 60005 |
| United States |
| Local Institution - 0016 | Shreveport | Louisiana | 71105 | United States |
| Local Institution - 0015 | New York | New York | 10029 | United States |
| Local Institution - 0026 | Chapel Hill | North Carolina | 27599-7080 | United States |
| Local Institution - 0013 | Cleveland | Ohio | 44195 | United States |
| Local Institution - 0020 | Oklahoma City | Oklahoma | 73112 | United States |
| Local Institution - 0032 | Garland | Texas | 75044 | United States |
| Local Institution - 0039 | Lubbock | Texas | 74910 | United States |
| Local Institution - 0033 | Southlake | Texas | 76092 | United States |
| Local Institution - 0005 | Sydney | New South Wales | 2010 | Australia |
| Local Institution - 0002 | Camberwell | Victoria | 3142 | Australia |
| Local Institution - 0007 | Edmonton | Alberta | T6K4B2 | Canada |
| Local Institution - 0025 | London | Ontario | N6A 5A5 | Canada |
| Local Institution - 0008 | Vaughan | Ontario | L4L 4Y7 | Canada |
| Local Institution - 0003 | Berlin | 12200 | Germany |
| Local Institution - 0019 | Dresden | 01307 | Germany |
| Local Institution - 0006 | Kiel | 24105 | Germany |
| Local Institution - 0009 | Amsterdam | North Holland | 1081 HZ | Netherlands |
| Local Institution - 0031 | Warsaw | Masovian Voivodeship | 02-798 | Poland |
| Local Institution - 0030 | Warsaw | Masovian Voivodeship | 04-501 | Poland |
| Local Institution - 0029 | Bydgoszcz | 85-231 | Poland |
| Local Institution - 0028 | Bydgoszcz | 85-794 | Poland |
| Local Institution - 0011 | San Juan | 00935 | Puerto Rico |
| Local Institution - 0023 | London | England | E11 1NR | United Kingdom |
| Local Institution - 0027 | Cambridge | CB2 0QQ | United Kingdom |
Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period. |
| FG002 | Placebo BID PO | Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO. |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Open-Label Treatment Period |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BMS-986165 12 mg BID | Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO. |
| BG001 | BMS-986165 6 mg BID | Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period and 6 mg BID in the open-label extension period. |
| BG002 | Placebo BID PO | Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO. |
| BG003 | 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 (NIH/OMB) | 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 in Clinical Response at Week 12 | Clinical response is defined as achieving the following changes in the modified Mayo score (excludes the physicians' global assessment)
Note: The modified Mayo score calculated to determine eligibility will also be used as the baseline disease activity score. The modified Mayo score is a 9-point scale (a score of 5 to 9 points denotes moderate to severe disease). The modified Mayo score is a sum of the following 3 components:
| Prespecified to be collected for all randomized participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02. | Posted | Number | 95% Confidence Interval | Percentage of participants | At week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Adverse Events (AEs) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. | All randomized participants who receive at least 1 dose of double-blind study treatment. Prespecified to be collected for participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02. | Posted | Count of Participants | Participants | From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Serious Adverse Events (SAEs) | An 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, results in persistent or significant disability or permanent damage, is a congenital anomaly/birth defect, is an important medical event. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. | All randomized participants who receive at least 1 dose of double-blind study treatment. Prespecified to be collected for participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02. | Posted | Count of Participants | Participants | From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Adverse Events (AEs) Leading to Discontinuation | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. Note: the first dose of study treatment in the open-label period may be the same as the last dose date of study treatment in double-blind treatment period, therefore, the participants analyzed in the open-label period may contain double blind participants finishing their last dose in the double-blind treatment period. | All randomized participants who receive at least 1 dose of double-blind study treatment. Prespecified to be collected for participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02. | Posted | Count of Participants | Participants | From first dose up to the last dose in the double-blind period or 30 days post the last dose date if not treated in the open-label period and from the first dose in open-label period up to 30 days post the last dose date (up to approximately 402 days) |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Participants Experiencing Adverse Events of Special Interest (AEIs) | An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study drug and that does not necessarily have a causal relationship with this treatment. AEs of special interest include: skin events, influenza, herpes viral infections, opportunistic infections, tuberculosis, cardiovascular events, malignancy, and COVID-19. | All randomized participants who receive at least 1 dose of double-blind study treatment. Prespecified to be collected for participants in Arms "BMS-986165 12 mg BID" and "Placebo BID PO". "BMS-986165 6 mg BID" was removed under Protocol Amendment 02. | Posted | Count of Participants | Participants | From first dose to 52 weeks after first dose |
|
All-cause mortality was assessed from first dose to study completion (up to approximately 420 days). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 402 days)
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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 | BMS-986165 12 mg BID (Double-Blind Treatment Period) | Participants receive BMS-986165 12 mg BID for a 12-week double-blind treatment period. | 0 | 26 | 4 | 26 | 19 | 26 |
| EG001 | BMS-986165 6 mg BID (Double-Blind Treatment Period) | Participants were randomized to the 6 mg BID arm under the Original Protocol or Protocol Amendment 01 receive 6 mg BID for the 12-week double-blind treatment period. | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Placebo BID PO (Double-Blind Treatment Period) | Participants receive placebo for a 12-week double-blind treatment period. | 0 | 8 | 1 | 8 | 6 | 8 |
| EG003 | BMS-986165 6 mg BID (Open-Label Treatment Period) | Eligible participants that move into the 40-week open-label extension period receive BMS-986165 6 mg BID PO. | 0 | 29 | 2 | 29 | 20 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anal fissure | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Bacteroides bacteraemia | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA 26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry eye | Eye disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Haemorrhoids | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Tongue dry | Gastrointestinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 26.1 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA 26.1 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 26.1 | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Magnesium deficiency | Metabolism and nutrition disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Dermatitis acneiform | Skin and subcutaneous tissue disorders | MedDRA 26.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 26.1 | 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 |
| May 29, 2024 |
| Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
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| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
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Not provided
| Participant request to discontinue treatment |
|
| Participant withdrew consent |
|
| Administrative reason by sponsor |
|
| Other reasons |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO. |
|
|
Participants receive placebo for a 12-week double-blind treatment period, then if eligible, move into the 40-week open-label extension period and receive BMS-986165 6 mg BID PO.
|
|
| Units | Counts |
|---|
| Participants |
|
|