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

Study Overview
=================
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.

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

Conditions
-----------------
Crohn Disease, Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Deucravacitinib


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-Term Extension Rollover Study: Deucravacitinib<br> | Drug: Deucravacitinib<br>* Specified dose on specified days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib