A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Long-Term Extension Rollover Study: Deucravacitinib
|
Drug: Deucravacitinib
Specified dose on specified days
|
Outcome Measures
Primary Outcome Measures
- Number of adverse events (AEs) [Up to Week 292]
- Number of serious adverse events (SAEs) [Up to Week 292]
- Number of AEs leading to study discontinuation [Up to Week 292]
- Number of clinically significant abnormalities in vital signs: Blood pressure [Up to Week 292]
- Number of clinically significant abnormalities in vital signs: Heart rate [Up to Week 292]
- Number of clinically significant abnormalities in vital signs: Temperature [Up to Week 292]
- Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval [Up to Week 292]
- Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval [Up to Week 292]
- Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval [Up to Week 292]
- Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval [Up to Week 292]
- Number of clinically significant abnormalities in clinical laboratory results: Hematology tests [Up to Week 292]
- Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test [Up to Week 292]
- Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests [Up to Week 292]
Eligibility Criteria
Criteria
Inclusion Criteria:
• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
Exclusion Criteria:
-
Women who are pregnant or breastfeeding
-
Current colonic adenomas or dysplasia diagnosed at the endoscopy performed at the end of treatment visit of the parent study or past confirmed colonic dysplasia in the parent study that has not been eradicated
Other protocol-defined inclusion/exclusion criteria apply
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Local Institution | Suwanee | Georgia | United States | 30024 |
2 | Louisiana Research Center-Research | Shreveport | Louisiana | United States | 71105 |
3 | West Michigan Clinical Research Center | Wyoming | Michigan | United States | 49519 |
4 | The University of Mississippi Medical Center-Clinical Research and Trials Unit | Jackson | Mississippi | United States | 39216 |
5 | Cleveland Clinic-Gastroenterology | Cleveland | Ohio | United States | 44195 |
6 | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | United States | 15213 |
7 | Local Institution - 0013 | Ballarat | Victoria | Australia | 3350 |
8 | Local Institution | Salvador | Bahia | Brazil | 40150-150 |
9 | Local Institution | Porto Alegre | RIO Grande DO SUL | Brazil | 90035903 |
10 | Local Institution | Sao Bernardo do Campo | SAO Paulo | Brazil | 09715-090 |
11 | Local Institution | Rio de Janeiro | Brazil | 21941-913 | |
12 | Local Institution | Guangzhou | Guangdong | China | 510080 |
13 | Local Institution | Guangzhou | Guangdong | China | 510655 |
14 | Local Institution | Changsha | Hunan | China | 410011 |
15 | Local Institution | City | Shanghai | China | 200120 |
16 | Local Institution | Shanghai | Shanghai | China | 200025 |
17 | Local Institution - 0012 | Kiel | Germany | 24105 | |
18 | Local Institution - 0023 | Budapest | Hungary | 1088 | |
19 | Humanitas | Rozzano | Lombardia | Italy | 20089 |
20 | Fondazione Irccs - Policlinico San Matteo | Pavia | Italy | 27100 | |
21 | Local Institution | Sakura | Chiba | Japan | 285-8741 |
22 | Local Institution | Saga-shi | Saga | Japan | 8498501 |
23 | Local Institution - 0026 | Bunkyo-ku | Tokyo | Japan | 1138519 |
24 | Local Institution - 0044 | Minato-ku | Tokyo | Japan | 105-8471 |
25 | Local Institution | Bydgoszcz | Poland | 85-231 | |
26 | Local Institution - 0003 | Bydgoszcz | Poland | 85-794 | |
27 | Local Institution | Krakow | Poland | 31-501 | |
28 | Local Institution | Sopot | Poland | 81-756 | |
29 | Local Institution | Szczecin | Poland | 71-434 | |
30 | Local Institution - 0004 | Warszawa | Poland | 03-712 | |
31 | Local Institution | Warszawa | Poland | 04-745 | |
32 | Local Institution | Wroclaw | Poland | 53-114 | |
33 | Local Institution | Bucharest | Romania | 020125 | |
34 | Local Institution | Irkutsk | Russian Federation | 664033 | |
35 | Local Institution | Saint Petersburg | Russian Federation | 195257 | |
36 | Local Institution | Saint-Petersburg | Russian Federation | 195257 | |
37 | Local Institution | Saratov | Russian Federation | 410053 | |
38 | Local Institution - 0045 | Fuenlabrada | Madrid | Spain | 28942 |
39 | Local Institution | Morriston | United Kingdom | SA6 6NL |
Sponsors and Collaborators
- Bristol-Myers Squibb
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- BMS Clinical Trial Information
- BMS Clinical Trial Patient Recruiting
- Investigator Inquiry Form
- FDA Safety Alerts and Recalls
Publications
None provided.- IM011-077
- 2020-004461-40
- U1111-1258-3838