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

NCT04877990 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IM011-0772020-004461-40U1111-1258-3838
• Study Type: interventional
• Target: 67
• Locations: 16 countries
• Sites: 43

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.

Conditions

Crohn Disease; Ulcerative Colitis

Keywords

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

Outcome Measures

Primary Outcomes (9)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

  Number of participants experiencing AEs, SAEs, AEs leading to study discontinuation, and AEs of interest (AEIs). An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. SAEs is any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization; results significant disability; or is a congenital anomaly/birth defect. TEAEs are defined as AEs with an onset date on or after the first dose of study treatment up to 30 days after the last dose of study treatment in the study, or if a pre-existing condition worsens in severity or becomes serious after receiving the first dose of study treatment

  From first dose to 30 days post last dose (Up to 110 weeks)

• Number of Participants With Laboratory Abnormalities

  Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.

  From first dose to 30 days post last dose (Up to 110 weeks)

• Number of Participants With Electrocardiogram (ECG) Abnormalities

  From first dose to 30 days post last dose (Up to 110 weeks)

• Number of Participants With Vital Signs Abnormalities

  From first dose to 30 days post last dose (Up to 110 weeks)

• Change From Baseline in Laboratory Parameters

  Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function

  Baseline, Week 12, Week 108

• Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate

  Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate

  Baseline, Week 48, Week 96

• Change From Baseline in Electrocardiogram (ECG) Parameters

  Changes from IM011077 study baseline in electrocardiogram (ECG) parameters

  Baseline, Week 48, Week 96

• Change From Baseline in Vital Signs Parameters - Heart Rate

  Changes from IM011077 study baseline in vital signs parameters - heart rate

  Baseline, Week 12, Week 108

• Change From Baseline in Vital Signs Parameters

  Changes from IM011077 study baseline in vital signs parameters

  Baseline, Week 12, Week 108

Study Arms (1)

Long-Term Extension Rollover Study: Deucravacitinib

EXPERIMENTAL

Drug: Deucravacitinib

Interventions

Deucravacitinib DRUG

Specified dose on specified days

Long-Term Extension Rollover Study: Deucravacitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (43)

Local Institution - 0036

Shreveport, Louisiana, 71105, United States

Location

Local Institution - 0002

Wyoming, Michigan, 49519, United States

Location

Local Institution - 0037

Jackson, Mississippi, 39216, United States

Location

Local Institution - 0041

Cleveland, Ohio, 44195, United States

Location

Local Institution - 0038

Pittsburgh, Pennsylvania, 15213, United States

Location

Local Institution - 0066

Charleston, South Carolina, 29425, United States

Location

Local Institution - 0053

Garland, Texas, 75044, United States

Location

Local Institution - 0056

San Antonio, Texas, 78229, United States

Location

Local Institution - 0049

Tyler, Texas, 75701, United States

Location

Local Institution - 0055

Richmond, Virginia, 23249, United States

Location

Local Institution - 0013

Ballarat, Victoria, 3350, Australia

Location

Local Institution - 0050

Vaughan, Ontario, L4L 4Y7, Canada

Location

Local Institution - 0030

Guangzhou, Guangdong, 510080, China

Location

Local Institution - 0029

Guangzhou, Guangdong, 510655, China

Location

Local Institution - 0012

Kiel, 24105, Germany

Location

Local Institution - 0062

Budapest, 1083, Hungary

Location

Local Institution - 0023

Budapest, 1088, Hungary

Location

Humanitas

Rozzano, Lombardy, 20089, Italy

Location

Fondazione Irccs - Policlinico San Matteo

Pavia, 27100, Italy

Location

Local Institution - 0063

Hirosaki, Aomori, 036-8545, Japan

Location

Local Institution - 0047

Sagamihara, Kanagawa, 252-0375, Japan

Location

Local Institution - 0027

Saga, Saga-ken, 8498501, Japan

Location

Local Institution - 0026

Bunkyo-ku, Tokyo, 1138519, Japan

Location

Local Institution - 0044

Minato-ku, Tokyo, 105-8471, Japan

Location

Local Institution - 0060

Amsterdam, North Holland, 1105 AZ, Netherlands

Location

Local Institution - 0046

Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland

Location

Local Institution - 0061

Tychy, Silesian Voivodeship, 43-100, Poland

Location

Local Institution - 0022

Bydgoszcz, 85-231, Poland

Location

Local Institution - 0003

Bydgoszcz, 85-794, Poland

Location

Local Institution - 0001

Krakow, 31-501, Poland

Location

Local Institution - 0028

Sopot, 81-756, Poland

Location

Local Institution - 0025

Szczecin, 71-434, Poland

Location

Local Institution - 0035

Warsaw, 00-728, Poland

Location

Local Institution - 0048

Warsaw, 02-798, Poland

Location

Local Institution - 0004

Warsaw, 03-712, Poland

Location

Local Institution - 0018

Wroclaw, 53-114, Poland

Location

Local Institution - 0054

Santa Maria da Feira, 4520-211, Portugal

Location

Local Institution

Bucharest, 020125, Romania

Location

Local Institution

Irkutsk, 664033, Russia

Location

Local Institution

Saint Petersburg, 195257, Russia

Location

Local Institution - 0045

Fuenlabrada, Madrid, 28942, Spain

Location

Local Institution - 0064

Taipei, 10002, Taiwan

Location

Local Institution - 0034

Morriston, SA6 6NL, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

deucravacitinib

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please Email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2021
• First Posted: May 7, 2021
• Study Start: May 7, 2021
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: September 24, 2024
• Results First Posted: September 24, 2024

Record last verified: 2024-08

Locations

US (10); JP (5); IT (2); CA (1); AU (1); RO (1); NL (1); PT (1); ES (1); PL (11); CN (2); HU (2); RU (2); DE (1); TW (1); GB (1)