Clinical trial NCT03934216: Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
Official title: A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of BMS-986165 in Subjects With Moderate to Severe Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2019-05-01
Enrollment: 131
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical Remission Response Rate at Week 12
timeFrame: From first dose to 12 weeks.
Secondary outcomes:
measure: Clinical Response Rate at 12 Weeks
timeFrame: From first dose to 12 weeks
measure: Endoscopic Response at Week 12
timeFrame: up to 12 Weeks
measure: Histological Improvement Response Rate at 12 Weeks
timeFrame: up to 12 Weeks
Other outcomes:
Locations:
city: Bristol
country: United States
facility: Connecticut Clinical Research Foundation
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: New Port Richey
country: United States
facility: Local Institution - 0048
state: Florida
city: Sweetwater
country: United States
facility: Local Institution - 0044
state: Florida
city: Suwanee
country: United States
facility: Local Institution - 0011
state: Georgia
city: Glenview
country: United States
facility: Local Institution - 0121
state: Illinois
city: Baton Rouge
country: United States
facility: Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
state: Louisiana
city: Shreveport
country: United States
facility: Local Institution - 0018
state: Louisiana
city: Chevy Chase
country: United States
facility: Local Institution - 0047
state: Maryland
city: Grand Rapids
country: United States
facility: Infusion Associates
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester
state: Minnesota
city: Las Vegas
country: United States
facility: Local Institution - 0002
state: Nevada
city: Lake Success
country: United States
facility: Local Institution - 0049
state: New York
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Hershey
country: United States
facility: Penn State Health Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charleston
country: United States
facility: Local Institution - 0074
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Garland
country: United States
facility: Local Institution - 0097
state: Texas
city: Houston
country: United States
facility: Local Institution - 0008
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Antonio
country: United States
facility: Local Institution - 0106
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake
state: Texas
city: Tyler
country: United States
facility: Local Institution - 0116
state: Texas
city: Seattle
country: United States
facility: Local Institution - 0096
state: Washington
city: Seattle
country: United States
facility: Swedish First Hill Campus
state: Washington
city: Vancouver
country: United States
facility: Local Institution - 0122
state: Washington
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution - 0071
state: South Australia
city: Melbourne
country: Australia
facility: Local Institution - 0108
state: Victoria
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
state: Western Australia
city: Antwerpen
country: Belgium
facility: Local Institution - 0039
city: Brussels
country: Belgium
facility: Local Institution - 0065
city: Liege
country: Belgium
facility: Clinique du MontLegia - CHC
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterology HK
city: Slany
country: Czechia
facility: Nemocnice Slany
city: Montpellier cedex 5
country: France
facility: Centre Hospitalier Universitaire de Montpellier
city: Pierre Benite Cedex
country: France
facility: Centre Hospitalier Lyon Sud
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
city: Toulouse cedex 9
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
city: Dresden
country: Germany
facility: Universitatsklinikum Carl Gustav Carus Dresden
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Local Institution - 0070
city: Leipzig
country: Germany
facility: Local Institution - 0062
city: Ulm
country: Germany
facility: Universitatsklinik Ulm
city: Budapest
country: Hungary
facility: Magyar Honvedseg-Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Local Institution - 0042
city: Budapest
country: Hungary
facility: Local Institution - 0024
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Gyongyos
country: Hungary
facility: Bugat Pal Korhaz
city: Rozzano
country: Italy
facility: Local Institution - 0033
state: Milano
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
city: Catanzaro
country: Italy
facility: Local Institution - 0005
city: Messina
country: Italy
facility: Clinica Medica Azienda Ospedaliera Universitaria
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
city: Pavia
country: Italy
facility: Local Institution - 0027
city: Roma
country: Italy
facility: Policlinico Universitario Campus Bio-Medico
city: Roma
country: Italy
facility: Local Institution - 0046
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
city: Hirosaki
country: Japan
facility: National Hospital Organization Hirosaki National Hospital
state: Aomori
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital
state: Fukuoka
city: Kurume
country: Japan
facility: Local Institution - 0078
state: Fukuoka
city: Takasaki
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
state: Gunma
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine Hospital
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Local Institution - 0081
state: Kanagawa
city: Otsu
country: Japan
facility: Shiga University of Medical Science Hospital
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Local Institution - 0066
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution - 0080
state: Tokyo
city: Saga
country: Japan
facility: Local Institution - 0069
city: Daegu
country: Korea, Republic of
facility: Local Institution - 0064
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Incheon
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution - 0091
city: Bydgoszcz
country: Poland
facility: Local Institution - 0013
city: Lodz
country: Poland
facility: Local Institution - 0100
city: Lodz
country: Poland
facility: Local Institution - 0045
city: Nowy Targ
country: Poland
facility: Local Institution - 0098
city: Piotrkow Trybunalski
country: Poland
facility: Local Institution - 0094
city: Sopot
country: Poland
facility: Local Institution - 0040
city: Szczecin
country: Poland
facility: Local Institution - 0053
city: Tychy
country: Poland
facility: Local Institution - 0014
city: Warszawa
country: Poland
facility: Centrum Zdrowia Matki Dziecka i Mlodziezy
city: Warszawa
country: Poland
facility: Local Institution - 0088
city: Warszawa
country: Poland
facility: Local Institution - 0095
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
city: Warszawa
country: Poland
facility: Local Institution - 0030
city: Wroclaw
country: Poland
facility: Local Institution - 0037
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Nizhniy Novgorod
country: Russian Federation
facility: Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0020
city: Novosibirsk
country: Russian Federation
facility: Novosibirsk State Regional Clinical Hospital
city: Novosibirsk
country: Russian Federation
facility: Local Institution - 0092
city: Saratov
country: Russian Federation
facility: Local Institution - 0015
city: Tyumen
country: Russian Federation
facility: Multidisciplinary Consultative and Diagnostic Center
city: Barnsley
country: United Kingdom
facility: Barnsley Hospital NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Local Institution - 0031
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: