A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis

Sponsor

Bristol-Myers Squibb (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04877990

Collaborator

(none)

300

Enrollment

Locations

Arm

72.9

Anticipated Duration (Months)

7.7

Patients Per Site

0.1

Patients Per Site Per Month

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
Crohn Disease Ulcerative Colitis	Drug: Deucravacitinib	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label, Multi-center Extension Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Crohn's Disease or Moderate to Severe Ulcerative Colitis

Actual Study Start Date :

May 7, 2021

Anticipated Primary Completion Date :

Jun 4, 2027

Anticipated Study Completion Date :

Jun 4, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long-Term Extension Rollover Study: Deucravacitinib	Drug: Deucravacitinib Specified dose on specified days

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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