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

Primary Purpose

Crohn Disease, Ulcerative Colitis

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Deucravacitinib

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Long-Term Extension Rollover Study: Deucravacitinib

Arm Description

Outcomes

Primary Outcome Measures

Number of adverse events (AEs)

Number of serious adverse events (SAEs)

Number of AEs leading to study discontinuation

Number of clinically significant abnormalities in vital signs: Blood pressure

Number of clinically significant abnormalities in vital signs: Heart rate

Number of clinically significant abnormalities in vital signs: Temperature

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval

Number of clinically significant abnormalities in clinical laboratory results: Hematology tests

Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test

Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests

Secondary Outcome Measures

Full Information

NCT ID

NCT04877990

First Posted

May 4, 2021

Last Updated

October 3, 2023

Sponsor

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT04877990

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Completed

Study Start Date

May 7, 2021 (Actual)

Primary Completion Date

August 29, 2023 (Actual)

Study Completion Date

August 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bristol-Myers Squibb

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Ulcerative Colitis

Keywords

BMS-986165, Crohn Colitis, Crohn Disease, Crohn Iliocolitis, Inflammatory Bowel Disease, Ulcerative Colitis, Deucravacitinib

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Long-Term Extension Rollover Study: Deucravacitinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Deucravacitinib

Intervention Description

Specified dose on specified days

Primary Outcome Measure Information:

Title

Number of adverse events (AEs)

Time Frame

Up to Week 292

Title

Number of serious adverse events (SAEs)

Time Frame

Up to Week 292

Title

Number of AEs leading to study discontinuation

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in vital signs: Blood pressure

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in vital signs: Heart rate

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in vital signs: Temperature

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in clinical laboratory results: Hematology tests

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test

Time Frame

Up to Week 292

Title

Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests

Time Frame

Up to Week 292

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bristol-Myers Squibb

Organizational Affiliation

Bristol-Myers Squibb

Official's Role

Study Director

Facility Information:

Facility Name

Local Institution - 0036

City

Shreveport

State/Province

Louisiana

ZIP/Postal Code

71105

Country

United States

Facility Name

Local Institution - 0002

City

Wyoming

State/Province

Michigan

ZIP/Postal Code

49519

Country

United States

Facility Name

Local Institution - 0037

City

Jackson

State/Province

Mississippi

ZIP/Postal Code

39216

Country

United States

Facility Name

Local Institution - 0041

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195

Country

United States

Facility Name

Local Institution - 0038

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

Local Institution - 0066

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

Local Institution - 0053

City

Garland

State/Province

Texas

ZIP/Postal Code

75044

Country

United States

Facility Name

Local Institution - 0056

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

Local Institution - 0049

City

Tyler

State/Province

Texas

ZIP/Postal Code

75701

Country

United States

Facility Name

Local Institution - 0055

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23249

Country

United States

Facility Name

Local Institution - 0013

City

Ballarat

State/Province

Victoria

ZIP/Postal Code

3350

Country

Australia

Facility Name

Local Institution - 0050

City

Vaughan

State/Province

Ontario

ZIP/Postal Code

L4L 4Y7

Country

Canada

Facility Name

Local Institution - 0030

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510080

Country

China

Facility Name

Local Institution - 0029

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510655

Country

China

Facility Name

Local Institution - 0012

City

Kiel

ZIP/Postal Code

24105

Country

Germany

Facility Name

Local Institution - 0062

City

Budapest

ZIP/Postal Code

1083

Country

Hungary

Facility Name

Local Institution - 0023

City

Budapest

ZIP/Postal Code

1088

Country

Hungary

Facility Name

Humanitas

City

Rozzano

State/Province

Lombardia

ZIP/Postal Code

20089

Country

Italy

Facility Name

Fondazione Irccs - Policlinico San Matteo

City

Pavia

ZIP/Postal Code

27100

Country

Italy

Facility Name

Local Institution - 0063

City

Hirosaki

State/Province

Aomori

ZIP/Postal Code

036-8545

Country

Japan

Facility Name

Local Institution - 0047

City

Sagamihara

State/Province

Kanagawa

ZIP/Postal Code

252-0375

Country

Japan

Facility Name

Local Institution - 0027

City

Saga-shi

State/Province

Saga

ZIP/Postal Code

8498501

Country

Japan

Facility Name

Local Institution - 0026

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

1138519

Country

Japan

Facility Name

Local Institution - 0044

City

Minato-ku

State/Province

Tokyo

ZIP/Postal Code

105-8471

Country

Japan

Facility Name

Local Institution - 0060

City

Amsterdam

State/Province

Noord-Holland

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Local Institution - 0046

City

Nowy Targ

State/Province

Małopolskie

ZIP/Postal Code

34-400

Country

Poland

Facility Name

Local Institution - 0022

City

Bydgoszcz

ZIP/Postal Code

85-231

Country

Poland

Facility Name

Local Institution - 0003

City

Bydgoszcz

ZIP/Postal Code

85-794

Country

Poland

Facility Name

Local Institution - 0001

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Local Institution - 0028

City

Sopot

ZIP/Postal Code

81-756

Country

Poland

Facility Name

Local Institution - 0025

City

Szczecin

ZIP/Postal Code

71-434

Country

Poland

Facility Name

Local Institution - 0035

City

Warsaw

ZIP/Postal Code

00-728

Country

Poland

Facility Name

Local Institution - 0048

City

Warsaw

ZIP/Postal Code

02-798

Country

Poland

Facility Name

Local Institution - 0004

City

Warszawa

ZIP/Postal Code

03-712

Country

Poland

Facility Name

Local Institution - 0018

City

Wroclaw

ZIP/Postal Code

53-114

Country

Poland

Facility Name

Local Institution - 0061

City

Tychy

State/Province

Śląskie

ZIP/Postal Code

43-100

Country

Poland

Facility Name

Local Institution - 0054

City

Santa Maria da Feira

ZIP/Postal Code

4520-211

Country

Portugal

Facility Name

Local Institution

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Local Institution

City

Irkutsk

ZIP/Postal Code

664033

Country

Russian Federation

Facility Name

Local Institution

City

Saint-Petersburg

ZIP/Postal Code

195257

Country

Russian Federation

Facility Name

Local Institution - 0045

City

Fuenlabrada

State/Province

Madrid

ZIP/Postal Code

28942

Country

Spain

Facility Name

Local Institution - 0064

City

Taipei

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

Local Institution - 0034

City

Morriston

ZIP/Postal Code

SA6 6NL

Country

United Kingdom

12. IPD Sharing Statement

Links:

URL

https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

Description

BMS Clinical Trial Information

URL

https://www.bmsstudyconnect.com/s/US/English/USenHome

Description

BMS Clinical Trial Patient Recruiting

URL

https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

Description

FDA Safety Alerts and Recalls

Learn more about this trial

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

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

Crohn Disease, Ulcerative Colitis

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial