Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-004694-27 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
Not provided
Not provided
Not provided
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BMS-986165 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMS-986165 | Drug | Specified Dose on Specified Days |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Remission Response Rate at Week 12 | Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1 | From first dose to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Response Rate at 12 Weeks | Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 |
Not provided
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria apply
Not provided
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Connecticut Clinical Research Foundation | Bristol | Connecticut | 06010 | United States | ||
| University of Florida |
Not provided
| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| BMS Clinical Trial Patient Recruiting | View source |
| FDA Safety Alerts and Recalls |
Not provided
131 Participants Randomized and 129 Treated
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | BMS-986-165 6mg BID |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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 | Apr 14, 2021 |
Not provided
Not provided
Not provided
Not provided
| Placebo | Other | Specified Dose on Specified Days |
|
| From first dose to 12 weeks |
| Endoscopic Response at Week 12 | Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern:
Bleeding
Erosions and Ulcers
A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8). | up to 12 Weeks |
| Histological Improvement Response Rate at 12 Weeks | Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score:
grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease | up to 12 Weeks |
| Gainesville |
| Florida |
| 32610-0316 |
| United States |
| University of Florida | Gainesville | Florida | 32611 | United States |
| Local Institution - 0048 | New Port Richey | Florida | 34653 | United States |
| Local Institution - 0044 | Sweetwater | Florida | 33172 | United States |
| Local Institution - 0011 | Suwanee | Georgia | 30024 | United States |
| Local Institution - 0121 | Glenview | Illinois | 60026 | United States |
| Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge | Baton Rouge | Louisiana | 70809 | United States |
| Local Institution - 0018 | Shreveport | Louisiana | 71103 | United States |
| Local Institution - 0047 | Chevy Chase | Maryland | 20815 | United States |
| Infusion Associates | Grand Rapids | Michigan | 49525 | United States |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | United States |
| Local Institution - 0002 | Las Vegas | Nevada | 89123 | United States |
| Local Institution - 0049 | Lake Success | New York | 11042 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Consultants for Clinical Research | Cincinnati | Ohio | 45218 | United States |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| Local Institution - 0074 | Charleston | South Carolina | 29425 | United States |
| Rapid City Medical Center | Rapid City | South Dakota | 57701 | United States |
| Gastro One | Germantown | Tennessee | 38138 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| Local Institution - 0097 | Garland | Texas | 75044 | United States |
| Local Institution - 0008 | Houston | Texas | 77090 | United States |
| Gastroenterology Research of San Antonio | San Antonio | Texas | 78229 | United States |
| Local Institution - 0106 | San Antonio | Texas | 78229 | United States |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | United States |
| Local Institution - 0116 | Tyler | Texas | 75701 | United States |
| Local Institution - 0096 | Seattle | Washington | 98101 | United States |
| Swedish First Hill Campus | Seattle | Washington | 98104 | United States |
| Local Institution - 0122 | Vancouver | Washington | 98664 | United States |
| Princess Alexandra Hospital | Woolloongabba | Queensland | 4102 | Australia |
| Local Institution - 0071 | Bedford Park | South Australia | 5042 | Australia |
| Local Institution - 0108 | Melbourne | Victoria | 3181 | Australia |
| Fiona Stanley Hospital | Murdoch | Western Australia | 6150 | Australia |
| Local Institution - 0039 | Antwerp | 2018 | Belgium |
| Local Institution - 0065 | Brussels | 1000 | Belgium |
| Clinique du MontLegia - CHC | Liège | 4000 | Belgium |
| Hepato-Gastroenterology HK | Hradec Králové | 500 12 | Czechia |
| Nemocnice Slany | Slaný | 274 01 | Czechia |
| Centre Hospitalier Universitaire de Montpellier | Montpellier | 34295 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord | Saint-Etienne | 42055 | France |
| Local Institution | Toulouse | 31059 | France |
| Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum | Berlin | 13353 | Germany |
| Universitatsklinikum Carl Gustav Carus Dresden | Dresden | 01307 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Local Institution - 0070 | Kiel | 24105 | Germany |
| Local Institution - 0062 | Leipzig | 04103 | Germany |
| Universitatsklinik Ulm | Ulm | 89081 | Germany |
| Magyar Honvedseg-Egeszsegugyi Kozpont | Budapest | 1062 | Hungary |
| Local Institution - 0042 | Budapest | 1088 | Hungary |
| Local Institution - 0024 | Budapest | 1097 | Hungary |
| Debreceni Egyetem Klinikai Kozpont | Debrecen | 4032 | Hungary |
| Bugat Pal Korhaz | Gyöngyös | 3200 | Hungary |
| Local Institution - 0033 | Rozzano | Milano | 20089 | Italy |
| Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi | Bologna | 40126 | Italy |
| Local Institution - 0005 | Catanzaro | 88100 | Italy |
| Clinica Medica Azienda Ospedaliera Universitaria | Messina | 98125 | Italy |
| Azienda Ospedaliera di Padova | Padova | 35128 | Italy |
| Local Institution - 0027 | Pavia | 27100 | Italy |
| Policlinico Universitario Campus Bio-Medico | Roma | 00128 | Italy |
| Local Institution - 0046 | Roma | 00133 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli | Roma | 00168 | Italy |
| National Hospital Organization Hirosaki National Hospital | Hirosaki | Aomori | 036-8545 | Japan |
| Fukuoka University Chikushi Hospital | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Local Institution - 0078 | Kurume | Fukuoka | 830-0011 | Japan |
| National Hospital Organization Takasaki General Medical Center | Takasaki | Gunma | 3700829 | Japan |
| Hyogo College of Medicine Hospital | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Local Institution - 0081 | Sagamihara-shi | Kanagawa | 2520375 | Japan |
| Shiga University of Medical Science Hospital | Ōtsu | Shiga | 520-2192 | Japan |
| Local Institution - 0066 | Bunkyo-ku | Tokyo | 113-8519 | Japan |
| Local Institution - 0080 | Minato-ku | Tokyo | 105-8471 | Japan |
| Local Institution - 0069 | Saga | 849-8501 | Japan |
| Local Institution - 0091 | Bydgoszcz | 85-231 | Poland |
| Local Institution - 0013 | Bydgoszcz | 85-794 | Poland |
| Local Institution - 0100 | Lodz | 90-153 | Poland |
| Local Institution - 0045 | Lodz | 90-302 | Poland |
| Local Institution - 0098 | Nowy Targ | 34-400 | Poland |
| Local Institution - 0094 | Piotrkow Trybunalski | 97-300 | Poland |
| Local Institution - 0040 | Sopot | 81-756 | Poland |
| Local Institution - 0053 | Szczecin | 71-434 | Poland |
| Local Institution - 0014 | Tychy | 43 100 | Poland |
| Centrum Zdrowia Matki Dziecka i Mlodziezy | Warsaw | 00-635 | Poland |
| Local Institution - 0088 | Warsaw | 00-728 | Poland |
| Local Institution - 0095 | Warsaw | 02-798 | Poland |
| Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz | Warsaw | 03-580 | Poland |
| Local Institution - 0030 | Warsaw | 03-712 | Poland |
| Local Institution - 0037 | Wroclaw | 53-114 | Poland |
| Centrum Medyczne Oporow | Wroclaw | 54-416 | Poland |
| Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko | Nizhny Novgorod | 603126 | Russia |
| Local Institution - 0020 | Novosibirsk | 630005 | Russia |
| Novosibirsk State Regional Clinical Hospital | Novosibirsk | 630087 | Russia |
| Local Institution - 0092 | Novosibirsk | 630099 | Russia |
| Local Institution - 0015 | Saratov | 410053 | Russia |
| Multidisciplinary Consultative and Diagnostic Center | Tyumen | 625026 | Russia |
| Local Institution - 0064 | Daegu | 42415 | South Korea |
| Local Institution | Daegu | 700-712 | South Korea |
| Local Institution | Daegu | 700-721 | South Korea |
| Local Institution | Incheon | 22332 | South Korea |
| Local Institution | Seoul | 137-701 | South Korea |
| Local Institution | Seoul | 156-755 | South Korea |
| Barnsley Hospital NHS Foundation Trust | Barnsley | S75 2EP | United Kingdom |
| Local Institution - 0031 | Cambridge | CB2 2QQ | United Kingdom |
| NHS Greater Glasgow and Clyde | Glasgow | G51 4TF | United Kingdom |
| Imperial College Healthcare NHS Trust | London | W2 1NY | United Kingdom |
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | S10 2JF | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | BMS-986-165 6mg BID |
| BG001 | Placebo | Placebo |
| 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 (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 | Clinical Remission Response Rate at Week 12 | Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding. Will be calculated using a modified Mayo score with the following: Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability) The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1 | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | From first dose to 12 weeks. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Response Rate at 12 Weeks | Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore Will be defined as the following: A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1 | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of participants | From first dose to 12 weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Endoscopic Response at Week 12 | Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score. The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale: Vascular Pattern:
Bleeding
Erosions and Ulcers
A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8). | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | up to 12 Weeks |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Histological Improvement Response Rate at 12 Weeks | Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1 Neutrophils <5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue. Achieving the following scores for the corresponding grades of the Geboes score:
grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease | All Randomized Participants | Posted | Number | 95% Confidence Interval | Percentage of Participants | up to 12 Weeks |
|
|
Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 104 Weeks All-Cause mortality (From randomization to end of study): Approximately 104 Weeks
The number at Risk for All-Cause Mortality represents all treated 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
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 | Treatment | BMS-986-165 6mg BID | 2 | 87 | 19 | 87 | 64 | 87 |
| EG001 | Placebo | Placebo | 0 | 10 | 2 | 10 | 6 | 10 |
| EG002 | BMS-986165 6mg BID During OL Period After Receiving Placebo in Induction Period | BMS-986165 6mg BID during OL period after receiving Placebo in Induction period | 0 | 32 | 4 | 32 | 22 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Congenital aural fistula | Congenital, familial and genetic disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Impaired gastric emptying | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Anal abscess | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 pneumonia | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Enterocolitis infectious | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Metabolic acidosis | Metabolism and nutrition disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Cervical spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Nasal septum deviation | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Aphthous ulcer | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Food poisoning | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Feeling cold | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 25.1 | Systematic Assessment |
| |
| Vaccination complication | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Hepatitis B DNA assay positive | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| SARS-CoV-2 test positive | Investigations | MedDRA 25.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Spinal pain | Musculoskeletal and connective tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA 25.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 25.1 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Bristol-Myers Squibb Study Director | Bristol-Myers Squibb | Please Email | Clinical.Trials@bms.com |
| Jun 6, 2022 |
| Prot_SAP_000.pdf |
| 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
Not provided
| ID | Term |
|---|---|
| C000628674 | deucravacitinib |
Not provided
Not provided
Not provided
| 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 |
|
|
|
|
|
|
|