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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

NCT ID: NCT04877990

Last Updated: 2024-09-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2023-08-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Crohn Disease Ulcerative Colitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Long-Term Extension Rollover Study: Deucravacitinib

Group Type EXPERIMENTAL

Deucravacitinib

Intervention Type DRUG

Specified dose on specified days

Interventions

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Deucravacitinib

Specified dose on specified days

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution - 0036

Shreveport, Louisiana, United States

Site Status

Local Institution - 0002

Wyoming, Michigan, United States

Site Status

Local Institution - 0037

Jackson, Mississippi, United States

Site Status

Local Institution - 0041

Cleveland, Ohio, United States

Site Status

Local Institution - 0038

Pittsburgh, Pennsylvania, United States

Site Status

Local Institution - 0066

Charleston, South Carolina, United States

Site Status

Local Institution - 0053

Garland, Texas, United States

Site Status

Local Institution - 0056

San Antonio, Texas, United States

Site Status

Local Institution - 0049

Tyler, Texas, United States

Site Status

Local Institution - 0055

Richmond, Virginia, United States

Site Status

Local Institution - 0013

Ballarat, Victoria, Australia

Site Status

Local Institution - 0050

Vaughan, Ontario, Canada

Site Status

Local Institution - 0030

Guangzhou, Guangdong, China

Site Status

Local Institution - 0029

Guangzhou, Guangdong, China

Site Status

Local Institution - 0012

Kiel, , Germany

Site Status

Local Institution - 0062

Budapest, , Hungary

Site Status

Local Institution - 0023

Budapest, , Hungary

Site Status

Humanitas

Rozzano, Lombardy, Italy

Site Status

Fondazione Irccs - Policlinico San Matteo

Pavia, , Italy

Site Status

Local Institution - 0063

Hirosaki, Aomori, Japan

Site Status

Local Institution - 0047

Sagamihara, Kanagawa, Japan

Site Status

Local Institution - 0027

Saga, Saga-ken, Japan

Site Status

Local Institution - 0026

Bunkyo-ku, Tokyo, Japan

Site Status

Local Institution - 0044

Minato-ku, Tokyo, Japan

Site Status

Local Institution - 0060

Amsterdam, North Holland, Netherlands

Site Status

Local Institution - 0046

Nowy Targ, Lesser Poland Voivodeship, Poland

Site Status

Local Institution - 0061

Tychy, Silesian Voivodeship, Poland

Site Status

Local Institution - 0022

Bydgoszcz, , Poland

Site Status

Local Institution - 0003

Bydgoszcz, , Poland

Site Status

Local Institution - 0001

Krakow, , Poland

Site Status

Local Institution - 0028

Sopot, , Poland

Site Status

Local Institution - 0025

Szczecin, , Poland

Site Status

Local Institution - 0035

Warsaw, , Poland

Site Status

Local Institution - 0048

Warsaw, , Poland

Site Status

Local Institution - 0004

Warsaw, , Poland

Site Status

Local Institution - 0018

Wroclaw, , Poland

Site Status

Local Institution - 0054

Santa Maria da Feira, , Portugal

Site Status

Local Institution

Bucharest, , Romania

Site Status

Local Institution

Irkutsk, , Russia

Site Status

Local Institution

Saint Petersburg, , Russia

Site Status

Local Institution - 0045

Fuenlabrada, Madrid, Spain

Site Status

Local Institution - 0064

Taipei, , Taiwan

Site Status

Local Institution - 0034

Morriston, , United Kingdom

Site Status

Countries

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United States Australia Canada China Germany Hungary Italy Japan Netherlands Poland Portugal Romania Russia Spain Taiwan United Kingdom

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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

BMS Clinical Trial Information

http://www.BMSStudyConnect.com

BMS Clinical Trial Patient Recruiting

Other Identifiers

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2020-004461-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1258-3838

Identifier Type: REGISTRY

Identifier Source: secondary_id

IM011-077

Identifier Type: -

Identifier Source: org_study_id

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