Phase
Condition
Colic
Inflammatory Bowel Disease
Crohn's Disease
Treatment
Placebo-to-match GS-1427
Ustekinumab
GS-1427
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days durationbefore randomization, with the diagnosis confirmed by endoscopy and histology at anytime prior to randomization. Documentation of endoscopy and histology consistentwith the diagnosis of UC must be available in the source documents.
Individuals have UC with minimum disease extent of 15 cm from the anal verge.
Individuals have moderately to severely active UC as determined by endoscopyoccurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9points, including a centrally read endoscopic subscore of at least 2.
Individuals have an inadequate response or loss of response or are intolerant to atleast 1 of the following UC treatments: corticosteroids, immunomodulators, oradvanced therapy.
Individuals have an inadequate response or loss of response or are intolerant to < 3AT mechanisms of action for UC (use of 2 or more AT with the same mechanism ofaction, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)
Exclusion
Key Exclusion Criteria:
Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive ofCD, diagnosis of indeterminate colitis due to etiologies such as an entericpathogen, or lymphocytic or collagenous colitis.
Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acutesevere colitis, fulminant colitis, or abdominal abscess at screening orrandomization.
Have any history of exposure to vedolizumab or other integrin antagonists
Requirement for ongoing therapy with or use of any prohibited medication asspecified in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
Connect with a study center
Macquarie University
Sydney, New South Wales 2109
AustraliaActive - Recruiting
Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
South Brisbane, Queensland 4101
AustraliaActive - Recruiting
Princess Alexandra Hospital - Metro South Health
Woolloongabba, Queensland 4102
AustraliaActive - Recruiting
The Queen Elizabeth Hospital
Woodville, South Australia 5011
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre
Clayton, Victoria 3168
AustraliaActive - Recruiting
Northern Hospital - Northern Health
Epping, Victoria 3076
AustraliaActive - Recruiting
Saint Vincent's Hospital Melbourne
Fitzroy, Victoria 3065
AustraliaActive - Recruiting
Footscray Hospital - Westerm Health
Footscray, Victoria 3011
AustraliaActive - Recruiting
Medical University Innsbruck, University Hospital for Internal Medicine I
Innsbruck, 6020
AustriaActive - Recruiting
Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology
Vienna, 1090
AustriaActive - Recruiting
Imeldaziekenhuis
Bonheiden, 2820
BelgiumActive - Recruiting
AZ Groeninge
Kortrijk, 8500
BelgiumActive - Recruiting
TDDA Specialty Reserach
Vaughan, L4L 4Y7
CanadaActive - Recruiting
Nemocnice Slany
Slany, 274 01
CzechiaActive - Recruiting
CHU Nantes Gastroenterology department
Nantes, 44000
FranceActive - Recruiting
Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology
Pierre-Benite, 69495
FranceActive - Recruiting
ARENSIA Exploratory Medicine
Tbilisi, 112
GeorgiaActive - Recruiting
AZ Groeninge
Halle (Saale), 06108
GermanyActive - Recruiting
University Hospital Schleswig-Holstein, Clinic for Internal Medicine
Kiel, 24105
GermanyActive - Recruiting
Princess Margaret Hospital
Hong Kong,
Hong KongActive - Recruiting
Queen Mary Hospital
Hong Kong, 999077
Hong KongActive - Recruiting
Clinexpert Gyógycentrum
Budapest, 1125
HungaryActive - Recruiting
Semmelweis Egyetem Általanos Orvostudományi Kar
Budapest, 1085
HungaryActive - Recruiting
San Raffaele Hospital IRCCS
Milano, 20089
ItalyActive - Recruiting
Campus Biomedico University Hospital Foundation
Roma, 00128
ItalyActive - Recruiting
Inje University Haeundae Paik Hospital IRB
Busan, 48108
Korea, Republic ofActive - Recruiting
Kyungpook National University Hospital
Daegu, 41944
Korea, Republic ofActive - Recruiting
The Catholic University of Korea Daejeon St.Mary's Hospital
Daejeon, 34943
Korea, Republic ofActive - Recruiting
Kyung Hee University Hospital
Guri-Si, 471-701
Korea, Republic ofActive - Recruiting
Kangbuk Samasung Hospital
Jongno-Gu, 03181
Korea, Republic ofActive - Recruiting
Kangbuk Samsung Hospital
Jongno-Gu, 03181
Korea, Republic ofActive - Recruiting
Yeungnam University Hospital
Nam-Gu, 42415
Korea, Republic ofActive - Recruiting
Hanyang University Seoul Hospital
Seongdong-gu, 4763
Korea, Republic ofActive - Recruiting
Asan Medical Center
Seoul, 05505
Korea, Republic ofActive - Recruiting
Samsung Medical Center
Seoul, 6351
Korea, Republic ofActive - Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 6591
Korea, Republic ofActive - Recruiting
Yonsei University Wonju Severance Christian Hospital
Wonju, 220-701
Korea, Republic ofActive - Recruiting
Hospital Universiti Sains Malaysia
Kota Bharu, Kelantan 16150
MalaysiaSite Not Available
Hospital Sultan Idris Shah Serdang
Kajang, Selangor 43000
MalaysiaSite Not Available
Hospital Universiti Sains Malaysia
Kelantan, 16150
MalaysiaActive - Recruiting
Hospital Queen Elizabeth
Kota Kinabalu, 88586
MalaysiaActive - Recruiting
Hospital Tengku Ampuan Afzan
Kuantan, 25100
MalaysiaActive - Recruiting
Sultan Ahmad Shah Medical Centre @IIUM
Kuantan, 25200
MalaysiaActive - Recruiting
University Malaya Medical Centre
Petaling Jaya, 50603
MalaysiaActive - Recruiting
Hospital Sultan Idris Shah Serdang
Selangor, 43000
MalaysiaActive - Recruiting
PMSI Clinical Republican Hospital "Timofei Molneaga"
Chisinau, MD-2025
Moldova, Republic ofActive - Recruiting
NZOZ Holsamed - Oddzial Libero
Katowice, 40-600
PolandActive - Recruiting
Endoskopia Sp. z.o.o.
Kraków, 30-082
PolandActive - Recruiting
Krakowskie Centrum Medyczne Sp. z o.o.
Kraków, 31-501
PolandActive - Recruiting
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054
PolandActive - Recruiting
Centrum Innowacyjnych Terapii Sp. z o.o.
Mazowieckie, 05-500
PolandActive - Recruiting
Gabinety Lekarskie RIVERMED
Poznan, 61-441
PolandActive - Recruiting
EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium
Poznań, 60-309
PolandActive - Recruiting
Centrum Medyczne Medyk Sp. z 0.0. sp.k.
Rzeszów, 35-301
PolandActive - Recruiting
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.
Szczecin, 71-434
PolandActive - Recruiting
Gastromed Sp. z.o.o.
Torun, 87-100
PolandActive - Recruiting
H-T Centrum Medyczne - Endoterapia
Tychy, 43-100
PolandActive - Recruiting
Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
PolandActive - Recruiting
Przychodnia care Access Warsawa
Warsaw, 00-719
PolandActive - Recruiting
Bodyclinic Sp. z o.o. sp.k.
Warszawa, 00-332
PolandActive - Recruiting
Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warszawa, 03-580
PolandActive - Recruiting
Centrum Medyczne Oporow
Wroclaw, 52416
PolandActive - Recruiting
FutureMeds Wrocław
Wroclaw, 50-008
PolandSite Not Available
Przychodnia Euromedicare szpital euromedicare
Wrocław, 54-144
PolandActive - Recruiting
Centrul Medical Monza S.R.L
Bucharest, 11658
RomaniaActive - Recruiting
Spitalul Clinic Colentina
Bucuresti, 020125
RomaniaActive - Recruiting
Spitalul Clinic Judetean De Urgenta Cluj-Napoca
Cluj-Napoca, 3-5
RomaniaActive - Recruiting
Centrul De Gastroenterologie Dr. Goldis S.R.L
Timisoara, 300002
RomaniaActive - Recruiting
Changhua Christian Hospital
Changhua City, 505
TaiwanActive - Recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, 807
TaiwanActive - Recruiting
China Medical University Hospital
Taichung, 404327
TaiwanActive - Recruiting
Taichung Veterans General Hospital
Taichung, 40705
TaiwanActive - Recruiting
MacKay Memorial Hospital
Taipei, 10449
TaiwanActive - Recruiting
National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
Taipei, 100
TaiwanActive - Recruiting
Taipei Veterans General Hospital
Taipei, 11217
TaiwanActive - Recruiting
Chang Gung Memorial Hospital (CGMH)
Taoyuan City, 333
TaiwanActive - Recruiting
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
Cambridge, CB2 0QQ
United KingdomActive - Recruiting
Synexus Clinical Research Centre
Cardiff, CF159SS
United KingdomActive - Recruiting
Synexus North East Clinical Research Centre
Hexham, NE46 1QJ
United KingdomActive - Recruiting
Onyx Clinical Research (Clinic Location)
Peoria, Arizona 85381
United StatesActive - Recruiting
Om Research LLC
Camarillo, California 93010
United StatesActive - Recruiting
VVCRD Research
Garden Grove, California 92845
United StatesActive - Recruiting
310 Clinical Research
Inglewood, California 90301
United StatesActive - Recruiting
US San Diego Health System
La Jolla, California 92037
United StatesActive - Recruiting
Om Research LLC
Lancaster, California 93534
United StatesActive - Recruiting
United Medical Doctors
Murrieta, California 92563
United StatesActive - Recruiting
UCSF Benioff Children's Hospital Oakland
Oakland, California 94609
United StatesActive - Recruiting
Acclaim Clinical Research
San Diego, California 92120
United StatesActive - Recruiting
SDG Clinical Research, LLC
San Diego, California 92103
United StatesActive - Recruiting
Peak Gastroenterology Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
United Research Institute LLC
Hialeah, Florida 33016
United StatesActive - Recruiting
Encore Medical Research. LLC
Hollywood, Florida 33021
United StatesActive - Recruiting
Advance Research Center
Miami, Florida 33183
United StatesActive - Recruiting
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
Miami, Florida 33136
United StatesActive - Recruiting
Alliance Clinical Research of Tampa, LLC
New Port Richey, Florida 34653
United StatesActive - Recruiting
Clinical Research of Osceola
Orlando, Florida 34741
United StatesActive - Recruiting
Digestive and Liver Center of Florida, LLC
Orlando, Florida 32825
United StatesActive - Recruiting
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida 33612
United StatesActive - Recruiting
Encore Medical Research of Weston, LLC
Weston, Florida 33331
United StatesActive - Recruiting
Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
United StatesActive - Recruiting
EBGS Clinical Research Center
Snellville, Georgia 30078
United StatesActive - Recruiting
Louisiana Research Center, LLC
Shreveport, Louisiana 71105
United StatesActive - Recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21224
United StatesActive - Recruiting
Clinical Research Institute of Michigan, LLC.
Chesterfield, Michigan 48047
United StatesActive - Recruiting
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
Wyoming, Michigan 49519
United StatesActive - Recruiting
Mayo Clinic
Rochester, Minnesota 55905
United StatesActive - Recruiting
Gastroenterology Associates of North Mississippi
Oxford, Mississippi 38655
United StatesActive - Recruiting
Digestive Health Specialists (Clinic Visits)
Tupelo, Mississippi 38801
United StatesActive - Recruiting
St Charles Clinical Research
Saint Louis, Missouri 63141
United StatesSite Not Available
St Charles Clinical Research
Weldon Spring, Missouri 63304
United StatesActive - Recruiting
N.Y. Total Medical Care, PC
Brooklyn, New York 11215
United StatesActive - Recruiting
Lenox Hill Hospital
Manhasset, New York 11030
United StatesActive - Recruiting
NYU Grossman School of Medicne
New York, New York 10016
United StatesActive - Recruiting
Carolina Research
Greenville, North Carolina 27834
United StatesActive - Recruiting
Piedmont Healthcare
Statesville, North Carolina 28625
United StatesActive - Recruiting
Dayton Gastroenterology, LLC
Beavercreek, Ohio 45440
United StatesActive - Recruiting
Gastro Health Research
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio 44145
United StatesActive - Recruiting
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania 17033
United StatesActive - Recruiting
Care Access - Pottsville
Pottsville, Pennsylvania 17901
United StatesActive - Recruiting
Skyline gastroenterology of west Tennessee
Jackson, Tennessee 38301
United StatesActive - Recruiting
Quality Medical Research
Nashville, Tennessee 37211
United StatesActive - Recruiting
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee 37232
United StatesActive - Recruiting
Gastroenterology Research of San Antonio
Fredericksburg, Texas 78624
United StatesActive - Recruiting
Amel Med Llc
Georgetown, Texas 78628
United StatesActive - Recruiting
Southwest Clinical Trials
Houston, Texas 77074
United StatesActive - Recruiting
GI Alliance - Mansfield
Mansfield, Texas 76063
United StatesActive - Recruiting
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas 78212
United StatesActive - Recruiting
Southern Star Research Institute, LLC.
San Antonio, Texas 78229
United StatesActive - Recruiting
Tyler Research Institute, LLC.
Tyler, Texas 75701
United StatesActive - Recruiting
University of Virginia Medical Center
Charlottesville, Virginia 22908
United StatesActive - Recruiting
Emeritas Research Group
Lansdowne Town Center, Virginia 20176
United StatesActive - Recruiting
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia 24014
United StatesActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.