A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
- Registration Number
- NCT04877990
- Lead Sponsor
- Bristol-Myers Squibb
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
• Previously completed open-label extension treatment in one of the parent Crohn's disease or ulcerative colitis studies
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Long-Term Extension Rollover Study: Deucravacitinib Deucravacitinib -
- Primary Outcome Measures
Name Time Method Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) From first dose to 30 days post last dose (Up to 110 weeks) 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
Number of Participants With Laboratory Abnormalities From first dose to 30 days post last dose (Up to 110 weeks) Number of participants experiencing abnormalities in laboratory testing including chemistry, hematology, and renal.
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 Baseline, Week 12, Week 108 Change from baseline in laboratory parameters including lipid profile, chemistry liver function, chemistry (other), and chemistry renal function
Change From Baseline in Electrocardiogram (ECG) Parameters - ECG Mean Heart Rate Baseline, Week 48, Week 96 Changes from IM011077 study baseline in electrocardiogram (ECG) parameters - ECG mean heart rate
Change From Baseline in Electrocardiogram (ECG) Parameters Baseline, Week 48, Week 96 Changes from IM011077 study baseline in electrocardiogram (ECG) parameters
Change From Baseline in Vital Signs Parameters - Heart Rate Baseline, Week 12, Week 108 Changes from IM011077 study baseline in vital signs parameters - heart rate
Change From Baseline in Vital Signs Parameters Baseline, Week 12, Week 108 Changes from IM011077 study baseline in vital signs parameters
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (41)
Local Institution - 0036
🇺🇸Shreveport, Louisiana, United States
Local Institution - 0026
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0002
🇺🇸Wyoming, Michigan, United States
Local Institution - 0037
🇺🇸Jackson, Mississippi, United States
Local Institution - 0041
🇺🇸Cleveland, Ohio, United States
Local Institution - 0038
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0053
🇺🇸Garland, Texas, United States
Local Institution - 0066
🇺🇸Charleston, South Carolina, United States
Local Institution - 0056
🇺🇸San Antonio, Texas, United States
Local Institution - 0030
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0029
🇨🇳Guangzhou, Guangdong, China
Local Institution - 0049
🇺🇸Tyler, Texas, United States
Local Institution - 0055
🇺🇸Richmond, Virginia, United States
Local Institution - 0013
🇦🇺Ballarat, Victoria, Australia
Local Institution - 0050
🇨🇦Vaughan, Ontario, Canada
Local Institution - 0062
ðŸ‡ðŸ‡ºBudapest, Hungary
Humanitas
🇮🇹Rozzano, Lombardia, Italy
Local Institution - 0023
ðŸ‡ðŸ‡ºBudapest, Hungary
Local Institution - 0063
🇯🇵Hirosaki, Aomori, Japan
Local Institution - 0012
🇩🇪Kiel, Germany
Fondazione Irccs - Policlinico San Matteo
🇮🇹Pavia, Italy
Local Institution - 0047
🇯🇵Sagamihara, Kanagawa, Japan
Local Institution - 0027
🇯🇵Saga-shi, Saga, Japan
Local Institution - 0001
🇵🇱Krakow, Poland
Local Institution - 0044
🇯🇵Minato-ku, Tokyo, Japan
Local Institution - 0046
🇵🇱Nowy Targ, Małopolskie, Poland
Local Institution - 0022
🇵🇱Bydgoszcz, Poland
Local Institution - 0060
🇳🇱Amsterdam, Noord-Holland, Netherlands
Local Institution - 0003
🇵🇱Bydgoszcz, Poland
Local Institution - 0025
🇵🇱Szczecin, Poland
Local Institution - 0028
🇵🇱Sopot, Poland
Local Institution - 0048
🇵🇱Warsaw, Poland
Local Institution - 0004
🇵🇱Warszawa, Poland
Local Institution
🇷🇺Saint-Petersburg, Russian Federation
Local Institution - 0035
🇵🇱Warsaw, Poland
Local Institution - 0054
🇵🇹Santa Maria da Feira, Portugal
Local Institution - 0018
🇵🇱Wroclaw, Poland
Local Institution - 0061
🇵🇱Tychy, Śląskie, Poland
Local Institution - 0045
🇪🇸Fuenlabrada, Madrid, Spain
Local Institution - 0064
🇨🇳Taipei, Taiwan
Local Institution - 0034
🇬🇧Morriston, United Kingdom