Phase
Condition
Ulcers
Colic
Crohn's Disease
Treatment
Placebo
BMS-986165
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
For more information regarding Bristol-Myers Squibb Clinical Trial participation, pleasevisit www.BMSStudyConnect.com Inclusion Criteria:
- Must have active ulcerative colitis (UC) extending ≥ 15 cm from the anal verge andconfirmed by a screening/baseline colonoscopy/sigmoidoscopy prior to the randomizationvisit
- 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 9points, inclusive, which includes a stool frequency (SF) subscore of ≥ 2, and a rectalbleeding (RB) subscore ≥ 1, and a screening endoscopic (ES) subscore of ≥ 2
Exclusion
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 offulminant colitis, abdominal abscess, toxic megacolon, or bowel perforation Other protocol-defined inclusion/exclusion criteria apply
Study Design
Connect with a study center
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
AustraliaSite Not Available
Local Institution - 0071
Bedford Park, South Australia 5042
AustraliaSite Not Available
Local Institution
Ballarat, Victoria 3350
AustraliaSite Not Available
Local Institution - 0108
Melbourne, Victoria 3181
AustraliaSite Not Available
Fiona Stanley Hospital
Murdoch, Western Australia 6150
AustraliaSite Not Available
Local Institution - 0039
Antwerpen, 2018
BelgiumSite Not Available
Local Institution - 0065
Brussels, 1000
BelgiumSite Not Available
Clinique du MontLegia - CHC
Liege, 4000
BelgiumSite Not Available
Local Institution
New Westminister, British Columbia V3L 3W5
CanadaSite Not Available
Local Institution
Etobicoke, Ontario M9V 4B8
CanadaSite Not Available
Hepato-Gastroenterology HK
Hradec Kralove, 500 12
CzechiaSite Not Available
Nemocnice Slany
Slany, 274 01
CzechiaSite Not Available
Local Institution
Clichy Cedex, 92110
FranceSite Not Available
Centre Hospitalier Universitaire de Montpellier
Montpellier cedex 5, 34295
FranceSite Not Available
Local Institution
Pierre Benite, 69495
FranceSite Not Available
Centre Hospitalier Lyon Sud
Pierre Benite Cedex, 69495
FranceSite Not Available
Local Institution
Rennes Cedex 9, 35033
FranceSite Not Available
Centre Hospitalier Universitaire de Saint-Etienne - Hopital Nord
Saint-Etienne, 42055
FranceSite Not Available
Local Institution
Toulouse cedex 9, 31059
FranceSite Not Available
Charite Universitatsmedizin Berlin - Campus Virchow-Klinikum
Berlin, 13353
GermanySite Not Available
Universitatsklinikum Carl Gustav Carus Dresden
Dresden, 01307
GermanySite Not Available
Medizinische Hochschule Hannover
Hannover, 30625
GermanySite Not Available
Local Institution
Jena, 07747
GermanySite Not Available
Local Institution - 0070
Kiel, 24105
GermanySite Not Available
Local Institution - 0062
Leipzig, 04103
GermanySite Not Available
Local Institution
Munchen, 81377
GermanySite Not Available
Universitatsklinik Ulm
Ulm, 89081
GermanySite Not Available
Local Institution - 0024
Budapest, 1097
HungarySite Not Available
Local Institution - 0042
Budapest, 1088
HungarySite Not Available
Magyar Honvedseg-Egeszsegugyi Kozpont
Budapest, 1062
HungarySite Not Available
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
HungarySite Not Available
Bugat Pal Korhaz
Gy?gy?, 3200
HungarySite Not Available
Bugat Pal Korhaz
Gyongyos, 3200
HungarySite Not Available
Local Institution - 0033
Rozzano, Milano 20089
ItalySite Not Available
Azienda Ospedaliero-Universitaria di Bologna - Policlinico SantOrsola-Malpighi
Bologna, 40126
ItalySite Not Available
Local Institution - 0005
Catanzaro, 88100
ItalySite Not Available
Clinica Medica Azienda Ospedaliera Universitaria
Messina, 98125
ItalySite Not Available
Local Institution
Milan, 20121
ItalySite Not Available
Local Institution
Milano, 20153
ItalySite Not Available
Azienda Ospedaliera di Padova
Padova, 35128
ItalySite Not Available
Local Institution - 0027
Pavia, 27100
ItalySite Not Available
Fondazione Policlinico Universitario Agostino Gemelli
Roma, 00168
ItalySite Not Available
Local Institution - 0046
Roma, 00133
ItalySite Not Available
Policlinico Universitario Campus Bio-Medico
Roma, 00128
ItalySite Not Available
National Hospital Organization Hirosaki National Hospital
Hirosaki, Aomori 036-8545
JapanSite Not Available
Fukuoka University Chikushi Hospital
Chikushino, Fukuoka 818-8502
JapanSite Not Available
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka 818-8502
JapanSite Not Available
Local Institution - 0078
Kurume, Fukuoka 830-0011
JapanSite Not Available
Kurume University Hospital
Kurume-shi, Fukuoka 8300011
JapanSite Not Available
National Hospital Organization Takasaki General Medical Center
Takasaki, Gunma 3700829
JapanSite Not Available
National Hospital Organization Takasaki General Medical Center
Takasaki-Shi, Gunma 370-0829
JapanSite Not Available
Hyogo College of Medicine Hospital
Nishinomiya, Hyogo 663-8501
JapanSite Not Available
Hyogo College of Medicine Hospital
Nishinomiya-Shi, Hyogo 663-8501
JapanSite Not Available
Local Institution - 0081
Sagamihara-shi, Kanagawa 2520375
JapanSite Not Available
Shiga University of Medical Science Hospital
Otsu, Shiga 520-2192
JapanSite Not Available
Local Institution - 0066
Bunkyo-ku, Tokyo 113-8519
JapanSite Not Available
Local Institution - 0080
Minato-ku, Tokyo 105-8471
JapanSite Not Available
Local Institution - 0069
Saga, 849-8501
JapanSite Not Available
Saga University Hospital
Saga, 849-8501
JapanSite Not Available
Local Institution
Daegu, 700-712
Korea, Republic ofSite Not Available
Local Institution - 0064
Daegu, 42415
Korea, Republic ofSite Not Available
Local Institution
Incheon, 22332
Korea, Republic ofSite Not Available
Local Institution
Seoul, 156-755
Korea, Republic ofSite Not Available
Local Institution - 0013
Bydgoszcz, 85-794
PolandSite Not Available
Local Institution - 0091
Bydgoszcz, 85-231
PolandSite Not Available
Local Institution - 0045
Lodz, 90-302
PolandSite Not Available
Local Institution - 0100
Lodz, 90-153
PolandSite Not Available
Local Institution - 0098
Nowy Targ, 34-400
PolandSite Not Available
Local Institution
Piotrk?ybunalski, 97-300
PolandSite Not Available
Local Institution - 0094
Piotrkow Trybunalski, 97-300
PolandSite Not Available
Local Institution - 0040
Sopot, 81-756
PolandSite Not Available
Local Institution - 0053
Szczecin, 71-434
PolandSite Not Available
Local Institution - 0014
Tychy, 43 100
PolandSite Not Available
Centrum Zdrowia Matki Dziecka i Mlodziezy
Warszawa, 00-635
PolandSite Not Available
Local Institution - 0030
Warszawa, 03-712
PolandSite Not Available
Local Institution - 0088
Warszawa, 00-728
PolandSite Not Available
Local Institution - 0095
Warszawa, 02-798
PolandSite Not Available
Niepubliczny Zaklad Opieki Zdrowotnej VIVAMED Jadwiga Miecz
Warszawa, 03-580
PolandSite Not Available
LexMedica
Wroc?aw, 53-114
PolandSite Not Available
Centrum Medyczne Oporow
Wroclaw, 54-416
PolandSite Not Available
Local Institution - 0037
Wroclaw, 53-114
PolandSite Not Available
Nizhniy Novgorod Regional Clinical Hospital N.A. Semashko
Nizhniy Novgorod, 603126
Russian FederationSite Not Available
Local Institution - 0020
Novosibirsk, 630005
Russian FederationSite Not Available
Local Institution - 0092
Novosibirsk, 630099
Russian FederationSite Not Available
Novosibirsk State Regional Clinical Hospital
Novosibirsk, 630087
Russian FederationSite Not Available
Local Institution - 0015
Saratov, 410053
Russian FederationSite Not Available
Multidisciplinary Consultative and Diagnostic Center
Tyumen, 625026
Russian FederationSite Not Available
Barnsley Hospital NHS Foundation Trust
Barnsley, S75 2EP
United KingdomSite Not Available
Local Institution - 0031
Cambridge, CB2 2QQ
United KingdomSite Not Available
NHS Greater Glasgow and Clyde
Glasgow, G51 4TF
United KingdomSite Not Available
Imperial College Healthcare NHS Trust
London, W2 1NY
United KingdomSite Not Available
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S10 2JF
United KingdomSite Not Available
Connecticut Clinical Research Foundation
Bristol, Connecticut 06010
United StatesSite Not Available
University of Florida
Gainesville, Florida 32611
United StatesSite Not Available
Local Institution
Jacksonville, Florida 32207-4958
United StatesSite Not Available
Local Institution
Miami, Florida 33144
United StatesSite Not Available
Local Institution - 0048
New Port Richey, Florida 34653
United StatesSite Not Available
Local Institution - 0044
Sweetwater, Florida 33172
United StatesSite Not Available
Local Institution
Atlanta, Georgia 30342
United StatesSite Not Available
Local Institution - 0011
Suwanee, Georgia 30024
United StatesSite Not Available
Local Institution - 0121
Glenview, Illinois 60026
United StatesSite Not Available
Texas Digestive Disease Consultants - Gastroenterology Associates - Baton Rouge
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Local Institution - 0018
Shreveport, Louisiana 71103
United StatesSite Not Available
Local Institution
Annapolis, Maryland 21401
United StatesSite Not Available
Local Institution - 0047
Chevy Chase, Maryland 20815
United StatesSite Not Available
Infusion Associates
Grand Rapids, Michigan 49525
United StatesSite Not Available
Mayo Clinic - Rochester
Rochester, Minnesota 55905
United StatesSite Not Available
Local Institution - 0002
Las Vegas, Nevada 89123
United StatesSite Not Available
New York Langone Long Island Clinical Research Associates
Great Neck, New York 11021
United StatesSite Not Available
Local Institution - 0049
Lake Success, New York 11042
United StatesSite Not Available
New York University Langone Medical Center
New York, New York 10016
United StatesSite Not Available
Consultants for Clinical Research
Cincinnati, Ohio 45218
United StatesSite Not Available
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesSite Not Available
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Local Institution - 0074
Charleston, South Carolina 29425
United StatesSite Not Available
Rapid City Medical Center
Rapid City, South Dakota 57701
United StatesSite Not Available
Gastro One
Germantown, Tennessee 38138
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Local Institution - 0097
Garland, Texas 75044
United StatesSite Not Available
Local Institution - 0008
Houston, Texas 77090
United StatesSite Not Available
Gastroenterology Research of San Antonio
San Antonio, Texas 78229
United StatesSite Not Available
Local Institution - 0106
San Antonio, Texas 78229
United StatesSite Not Available
Texas Digestive Disease Consultants - Southlake
Southlake, Texas 76092
United StatesSite Not Available
Local Institution
Spring, Texas 77386
United StatesSite Not Available
Local Institution - 0116
Tyler, Texas 75701
United StatesSite Not Available
Local Institution - 0096
Seattle, Washington 98101
United StatesSite Not Available
Swedish First Hill Campus
Seattle, Washington 98104
United StatesSite Not Available
Virginia Mason Medical Center
Seattle, Washington 98101
United StatesSite Not Available
Local Institution
Spokane, Washington 99204
United StatesSite Not Available
Local Institution - 0122
Vancouver, Washington 98664
United StatesSite Not Available
The Vancouver Clinic
Vancouver, Washington 98664
United StatesSite Not Available

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