Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
- Registration Number
- NCT03934216
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 131
- Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge and confirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomization visit
- Must have documented diagnosis of UC of at least 3 months' duration prior to screening
- Must have active moderate to severe UC, as defined by a modified Mayo score of 5 to 9 points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectal bleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2
- Previous/current documented diagnosis of CD, indeterminate colitis, ischemic colitis, or pseudomembranous colitis (other than associated with Clostridium difficile [C. difficile])
- Stool positive for C. difficile toxin at screening visit
- Current or recent (within 12 weeks prior to the randomization visit) evidence of fulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation
Other protocol-defined inclusion/exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BMS-986165 BMS-986165 - Placebo Placebo -
- Primary Outcome Measures
Name Time Method Clinical Remission Response Rate at Week 12 From first dose to 12 weeks. Clinical remission response rate is the percentage of participants achieving clinical remission, defined as absolute total Mayo Score and absolute Mayo endoscopy, stool frequency, rectal bleeding.
Will be calculated using a modified Mayo score with the following:
Stool Frequency (SF) sub score ≤ 1, with ≥ 1 point decrease from baseline, and Rectal Bleeding (RB) sub score = 0, and Endoscopic (ES) sub score ≤ 1 (modified, excludes friability)
The modified Mayo score (0 to 9 points) is the sum of 3 components: the SF, RB, and ES sub scores
Modified Mayo Score: The modified Mayo score is a 9-point scale; a score of 5 to 9 points (inclusive), which is required for randomization, denotes moderate to severe disease (by protocol definition). considered in clinical remission if a Mayo Score of less than or equal to 2 with no individual sub score greater than 1
- Secondary Outcome Measures
Name Time Method Clinical Response Rate at 12 Weeks From first dose to 12 weeks Clinical response is defined as percentage of participants with a reduction in total Mayo Score and reduction in rectal bleeding subscore
Will be defined as the following:
A decrease from baseline in the modified Mayo score of ≥ 2 points, and A decrease from baseline in the modified Mayo score ≥ 30%, and A decrease in rectal bleeding(RB) subscore of ≥ 1 point or absolute RB subscore ≤ 1Endoscopic Response at Week 12 up to 12 Weeks Endoscopic response will be defined as percentage of participants with a reduction in the total Ulcerative Colitis Endoscopic Index of Severity score.
The Ulcerative Colitis Endoscopic Index of Severity (UCEIS) scale:
Vascular Pattern:
* Normal (score 0)
* patchy obliteration (score 1)
* Obliterated (score 2)
Bleeding
* None (score 0)
* Mucosal (score 1)
* Luminal mild (score 2)
* Luminal Moderate or severe (score 3)
Erosions and Ulcers
* None (score 0)
* Erosions ( score 1)
* Superficial Ulcer (2)
* Deep Ulcer (score 3)
A total score represents the following: remission (0-1); mild (2-4); moderate (5-6); and severe (7-8).Histological Improvement Response Rate at 12 Weeks up to 12 Weeks Histologic improvement is defined as percentage of participants with a Geboes score of ≤ 3.1
Neutrophils \<5% of crypts, with no crypt destruction, erosions, ulcerations, and granulation tissue.
Achieving the following scores for the corresponding grades of the Geboes score:
* Score of 0 or 1 for Grade 3 (neutrophils in the epithelium: none or \< 5% crypts involved), and
* Score of 0 for Grade 4 (crypt destruction: none), and
* Score of 0 Grade 5 (erosion or ulceration: no erosions, ulcerations, or granulation tissue)
grade 1 = chronic inflammatory infiltrate; grade 2 = lamina propria neutrophils and eosinophils; grade 3 = neutrophils in the epithelium; grade 4 = crypt destruction; grade 5 = erosions or ulceration. A higher score indicates more severe disease
Trial Locations
- Locations (101)
Penn State Health Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Local Institution - 0065
🇧🇪Brussels, Belgium
Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
🇩🇪Berlin, Germany
Local Institution
🇰🇷Seoul, Korea, Republic of
Local Institution - 0070
🇩🇪Kiel, Germany
Policlinico Universitario Campus Bio-Medico
🇮🇹Roma, Italy
Local Institution - 0049
🇺🇸Lake Success, New York, United States
Nemocnice Slany
🇨🇿Slany, Czechia
Local Institution - 0027
🇮🇹Pavia, Italy
Local Institution - 0108
🇦🇺Melbourne, Victoria, Australia
Local Institution - 0122
🇺🇸Vancouver, Washington, United States
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite Cedex, France
Local Institution - 0091
🇵🇱Bydgoszcz, Poland
Local Institution - 0098
🇵🇱Nowy Targ, Poland
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
🇵🇱Warszawa, Poland
Local Institution - 0037
🇵🇱Wroclaw, Poland
Local Institution - 0039
🇧🇪Antwerpen, Belgium
Local Institution - 0069
🇯🇵Saga, Japan
Universitatsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Hyogo College of Medicine Hospital
🇯🇵Nishinomiya, Hyogo, Japan
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
National Hospital Organization Hirosaki National Hospital
🇯🇵Hirosaki, Aomori, Japan
Texas Digestive Disease Consultants - Southlake
🇺🇸Southlake, Texas, United States
Local Institution - 0081
🇯🇵Sagamihara-shi, Kanagawa, Japan
Gastro One
🇺🇸Germantown, Tennessee, United States
Clinique du MontLegia - CHC
🇧🇪Liege, Belgium
Hepato-Gastroenterology HK
🇨🇿Hradec Kralove, Czechia
Local Institution - 0042
🇭🇺Budapest, Hungary
Local Institution - 0078
🇯🇵Kurume, Fukuoka, Japan
Princess Alexandra Hospital
🇦🇺Woolloongabba, Queensland, Australia
Local Institution - 0053
🇵🇱Szczecin, Poland
Local Institution - 0014
🇵🇱Tychy, Poland
Local Institution - 0095
🇵🇱Warszawa, Poland
Multidisciplinary Consultative and Diagnostic Center
🇷🇺Tyumen, Russian Federation
Local Institution - 0030
🇵🇱Warszawa, Poland
Local Institution - 0100
🇵🇱Lodz, Poland
Local Institution - 0045
🇵🇱Lodz, Poland
Local Institution - 0040
🇵🇱Sopot, Poland
Barnsley Hospital NHS Foundation Trust
🇬🇧Barnsley, United Kingdom
Shiga University of Medical Science Hospital
🇯🇵Otsu, Shiga, Japan
Centrum Zdrowia Matki Dziecka i Mlodziezy
🇵🇱Warszawa, Poland
Local Institution - 0088
🇵🇱Warszawa, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, United Kingdom
Local Institution - 0020
🇷🇺Novosibirsk, Russian Federation
Local Institution - 0031
🇬🇧Cambridge, United Kingdom
Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
🇷🇺Nizhniy Novgorod, Russian Federation
NHS Greater Glasgow and Clyde
🇬🇧Glasgow, United Kingdom
Local Institution - 0015
🇷🇺Saratov, Russian Federation
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Local Institution - 0047
🇺🇸Chevy Chase, Maryland, United States
Consultants for Clinical Research
🇺🇸Cincinnati, Ohio, United States
Local Institution - 0008
🇺🇸Houston, Texas, United States
Local Institution - 0096
🇺🇸Seattle, Washington, United States
Swedish First Hill Campus
🇺🇸Seattle, Washington, United States
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
University of Florida
🇺🇸Gainesville, Florida, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Local Institution - 0066
🇯🇵Bunkyo-ku, Tokyo, Japan
Local Institution - 0080
🇯🇵Minato-ku, Tokyo, Japan
Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Local Institution - 0046
🇮🇹Roma, Italy
National Hospital Organization Takasaki General Medical Center
🇯🇵Takasaki, Gunma, Japan
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
🇫🇷Saint-Etienne, France
Centre Hospitalier Universitaire de Montpellier
🇫🇷Montpellier cedex 5, France
Local Institution - 0092
🇷🇺Novosibirsk, Russian Federation
Infusion Associates
🇺🇸Grand Rapids, Michigan, United States
Local Institution - 0097
🇺🇸Garland, Texas, United States
Gastroenterology Research of San Antonio
🇺🇸San Antonio, Texas, United States
Local Institution - 0106
🇺🇸San Antonio, Texas, United States
Local Institution - 0116
🇺🇸Tyler, Texas, United States
Connecticut Clinical Research Foundation
🇺🇸Bristol, Connecticut, United States
Local Institution - 0044
🇺🇸Sweetwater, Florida, United States
Local Institution - 0048
🇺🇸New Port Richey, Florida, United States
Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Local Institution - 0121
🇺🇸Glenview, Illinois, United States
Local Institution - 0018
🇺🇸Shreveport, Louisiana, United States
Local Institution - 0002
🇺🇸Las Vegas, Nevada, United States
Local Institution - 0011
🇺🇸Suwanee, Georgia, United States
Mayo Clinic - Rochester
🇺🇸Rochester, Minnesota, United States
New York University Langone Medical Center
🇺🇸New York, New York, United States
Rapid City Medical Center
🇺🇸Rapid City, South Dakota, United States
Local Institution - 0074
🇺🇸Charleston, South Carolina, United States
Magyar Honvedseg-Egeszsegugyi Kozpont
🇭🇺Budapest, Hungary
Local Institution - 0062
🇩🇪Leipzig, Germany
Universitatsklinik Ulm
🇩🇪Ulm, Germany
Local Institution - 0024
🇭🇺Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
🇭🇺Debrecen, Hungary
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
🇮🇹Bologna, Italy
Bugat Pal Korhaz
🇭🇺Gyongyos, Hungary
Local Institution - 0033
🇮🇹Rozzano, Milano, Italy
Clinica Medica Azienda Ospedaliera Universitaria
🇮🇹Messina, Italy
Local Institution - 0005
🇮🇹Catanzaro, Italy
Fukuoka University Chikushi Hospital
🇯🇵Chikushino, Fukuoka, Japan
Fondazione Policlinico Universitario Agostino Gemelli
🇮🇹Roma, Italy
Local Institution - 0013
🇵🇱Bydgoszcz, Poland
Local Institution - 0064
🇰🇷Daegu, Korea, Republic of
Local Institution - 0094
🇵🇱Piotrkow Trybunalski, Poland
Novosibirsk State Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Imperial College Healthcare NHS Trust
🇬🇧London, United Kingdom
Local Institution - 0071
🇦🇺Bedford Park, South Australia, Australia