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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04877990
• Other study ID #: IM011-077
• Secondary ID: 2020-004461-40U1
• Status: Completed
• Phase: Phase 2
• Start date: May 7, 2021
• Est. completion date: August 29, 2023

Study information

• Verified date: October 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 29, 2023
• Est. primary completion date: August 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Ulcer
• Ulcerative Colitis

Intervention

Drug:
• Deucravacitinib
Specified dose on specified days

Locations

Country	Name	City	State
Australia	Local Institution - 0013	Ballarat	Victoria
Canada	Local Institution - 0050	Vaughan	Ontario
China	Local Institution - 0029	Guangzhou	Guangdong
China	Local Institution - 0030	Guangzhou	Guangdong
Germany	Local Institution - 0012	Kiel
Hungary	Local Institution - 0023	Budapest
Hungary	Local Institution - 0062	Budapest
Italy	Fondazione Irccs - Policlinico San Matteo	Pavia
Italy	Humanitas	Rozzano	Lombardia
Japan	Local Institution - 0026	Bunkyo-ku	Tokyo
Japan	Local Institution - 0063	Hirosaki	Aomori
Japan	Local Institution - 0044	Minato-ku	Tokyo
Japan	Local Institution - 0027	Saga-shi	Saga
Japan	Local Institution - 0047	Sagamihara	Kanagawa
Netherlands	Local Institution - 0060	Amsterdam	Noord-Holland
Poland	Local Institution - 0003	Bydgoszcz
Poland	Local Institution - 0022	Bydgoszcz
Poland	Local Institution - 0001	Krakow
Poland	Local Institution - 0046	Nowy Targ	Malopolskie
Poland	Local Institution - 0028	Sopot
Poland	Local Institution - 0025	Szczecin
Poland	Local Institution - 0061	Tychy	Slaskie
Poland	Local Institution - 0035	Warsaw
Poland	Local Institution - 0048	Warsaw
Poland	Local Institution - 0004	Warszawa
Poland	Local Institution - 0018	Wroclaw
Portugal	Local Institution - 0054	Santa Maria da Feira
Romania	Local Institution	Bucharest
Russian Federation	Local Institution	Irkutsk
Russian Federation	Local Institution	Saint-Petersburg
Spain	Local Institution - 0045	Fuenlabrada	Madrid
Taiwan	Local Institution - 0064	Taipei
United Kingdom	Local Institution - 0034	Morriston
United States	Local Institution - 0066	Charleston	South Carolina
United States	Local Institution - 0041	Cleveland	Ohio
United States	Local Institution - 0053	Garland	Texas
United States	Local Institution - 0037	Jackson	Mississippi
United States	Local Institution - 0038	Pittsburgh	Pennsylvania
United States	Local Institution - 0055	Richmond	Virginia
United States	Local Institution - 0056	San Antonio	Texas
United States	Local Institution - 0036	Shreveport	Louisiana
United States	Local Institution - 0049	Tyler	Texas
United States	Local Institution - 0002	Wyoming	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of adverse events (AEs)		Up to Week 292
Primary	Number of serious adverse events (SAEs)		Up to Week 292
Primary	Number of AEs leading to study discontinuation		Up to Week 292
Primary	Number of clinically significant abnormalities in vital signs: Blood pressure		Up to Week 292
Primary	Number of clinically significant abnormalities in vital signs: Heart rate		Up to Week 292
Primary	Number of clinically significant abnormalities in vital signs: Temperature		Up to Week 292
Primary	Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: PR interval		Up to Week 292
Primary	Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QRS interval		Up to Week 292
Primary	Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QT interval		Up to Week 292
Primary	Number of clinically significant abnormalities in electrocardiogram (ECG) parameters: QTc interval		Up to Week 292
Primary	Number of clinically significant abnormalities in clinical laboratory results: Hematology tests		Up to Week 292
Primary	Number of clinically significant abnormalities in clinical laboratory results: Clinical Chemistry test		Up to Week 292
Primary	Number of clinically significant abnormalities in clinical laboratory results: Coagulation tests		Up to Week 292

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls