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Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Sponsor: Gilead Sciences
Summary
The goal of this study is to learn if emvistegrast (formerly GS-1427) is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with emvistegrast with participants treated with placebo. The primary objective of this study is to assess the efficacy of emvistegrast, compared with placebo control, in achieving clinical response at Week 12.
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
228
Start Date
2024-03-27
Completion Date
2028-04
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
emvistegrast
Administered orally
Placebo-to-match emvistegrast
Administered orally
Locations (181)
Onyx Clinical Research (Clinic Location)
Peoria, Arizona, United States
Om Research LLC
Camarillo, California, United States
VVCRD Research
Garden Grove, California, United States
310 Clinical Research
Inglewood, California, United States
US San Diego Health System
La Jolla, California, United States
Om Research LLC
Lancaster, California, United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States
University Of California, Davis
Sacramento, California, United States
SDG Clinical Research, LLC
San Diego, California, United States
Acclaim Clinical Research
San Diego, California, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, United States
Gastro Florida
Clearwater, Florida, United States
Best Quality Research, Inc
Hialeah, Florida, United States
United Research Institute LLC
Hialeah, Florida, United States
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
Miami, Florida, United States
Medical Professional Clinical Research Center, Inc.
Miami, Florida, United States
Blessed Health Care & Research, Inc
Miami, Florida, United States
Alliance Clinical Research of Tampa, LLC
New Port Richey, Florida, United States
Digestive and Liver Center of Florida, LLC
Orlando, Florida, United States
Clinical Research of Osceola
Orlando, Florida, United States
Encore Medical Research of Weston, LLC
Weston, Florida, United States
EBGS Clinical Research Center
Snellville, Georgia, United States
The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)
Chicago, Illinois, United States
Onyx Clinical Research
Peoria, Illinois, United States
Robley Rex VA Medical Center
Louisville, Kentucky, United States
Louisiana Research Center, LLC
Shreveport, Louisiana, United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
Wyoming, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, United States
Digestive Health Specialists (Clinic Visits)
Tupelo, Mississippi, United States
St Charles Clinical Research
Weldon Spring, Missouri, United States
Tandem - Allied Clinical Research, LLC
Freehold, New Jersey, United States
N.Y. Total Medical Care, PC
Brooklyn, New York, United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States
Lenox Hill Hospital
Manhasset, New York, United States
NYU Grossman School of Medicne
New York, New York, United States
Carolina Research
Greenville, North Carolina, United States
Piedmont Healthcare
Statesville, North Carolina, United States
Dayton Gastroenterology, LLC
Beavercreek, Ohio, United States
Gastro Health Research
Cincinnati, Ohio, United States
NexGen Research
Lima, Ohio, United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Skyline gastroenterology of west Tennessee
Jackson, Tennessee, United States
Quality Medical Research
Nashville, Tennessee, United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, United States
Gastroenterology Research of San Antonio
Fredericksburg, Texas, United States
Amel Med Llc
Georgetown, Texas, United States
GI Alliance - Mansfield
Mansfield, Texas, United States
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, United States
Southern Star Research Institute, LLC.
San Antonio, Texas, United States
Tyler Research Institute, LLC.
Tyler, Texas, United States
University of Virginia Medical Center
Charlottesville, Virginia, United States
Emeritas Research Group
Lansdowne Town Center, Virginia, United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, United States
Macquarie University
Sydney, New South Wales, Australia
Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
South Brisbane, Queensland, Australia
Princess Alexandra Hospital - Metro South Health
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Monash Health - Monash Medical Centre
Clayton, Victoria, Australia
Northern Hospital - Northern Health
Epping, Victoria, Australia
Saint Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
Footscray Hospital - Westerm Health
Footscray, Victoria, Australia
Medical University Innsbruck, University Hospital for Internal Medicine I
Innsbruck, Austria
Regional Hospital Salzburg, University Clinic for Internal Medicine I
Salzburg, Austria
Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology
Vienna, Austria
Imeldaziekenhuis
Bonheiden, Belgium
AZ Groeninge
Kortrijk, Belgium
Vitaz
Sint-Niklaas, Belgium
TDDA Specialty Reserach
Vaughan, Canada
PreventaMed, s.r.o.
Olomouc, Czechia
Nemocnice Slany
Slaný, Czechia
Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D
La Tronche, France
CHU Nantes Gastroenterology department
Nantes, France
Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology
Pierre-Bénite, France
ARENSIA Exploratory Medicine
Tbilisi, Georgia
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik |
Dresden, Germany
Studiengesellschaft BSF UG
Halle, Germany
University Hospital Schleswig-Holstein, Clinic for Internal Medicine
Kiel, Germany
Ulm University Hospital, Centre for Internal Medicine I
Ulm, Germany
Queen Mary Hospital
Hong Kong, Hong Kong
Princess Margaret Hospital
Hong Kong, Hong Kong
Békés Varmegye Kozponti Korhaz, dr Rethy Pal 4. Belgyégyaszat - Gasztroenterologia
Békéscsaba, Hungary
Semmelweis Egyetem AOK
Budapest, Hungary
Semmelweis Egyetem Általanos Orvostudományi Kar
Budapest, Hungary
Clinexpert Gyógycentrum
Budapest, Hungary
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Bologna, Italy
Azienda Ospedaliera Brotzu - P.O. San Michele
Cagliari, Italy
AOU "Renato Dulbecco" - Digestive Physiopathology Unit
Catanzaro, Italy
San Raffaele Hospital IRCCS
Milan, Italy
IRCCS Ospedale Sacro Cuore Don Calabria
Negrar, Italy
Azienda Ospedale Universita di Padova
Padova, Italy
AOOR Villa Sofia- Cervello
Palermo, Italy
Campus Biomedico University Hospital Foundation
Roma, Italy
Ospedale Sandro Pertini
Roma, Italy
IRCCS Policlinico San Donato
San Donato Milanese, Italy
Ospedale Casa Sollievo della Sofferenza IRCCS, Opera di San Pio da Pietrelcina
San Giovanni Rotondo, Italy
Azienda Ospedaliera Ordine Mauriziano di Torino
Torino, Italy
Hospital Sultanah Aminah
Johor Bahru, Malaysia
Hospital Universiti Sains Malaysia
Kelantan, Malaysia
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia
Hospital Sultan Idris Shah Serdang
Kuala Selangor, Malaysia
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia
Sultan Ahmad Shah Medical Centre @IIUM
Kuantan, Malaysia
University Malaya Medical Centre
Petaling Jaya, Malaysia
PMSI Clinical Republican Hospital "Timofei Molneaga"
Chisinau, Moldova
Pacific Clinical Research Network - Auckland
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital
Dunedin, New Zealand
Centrum Medyczne "Medis"
Bydgoszcz, Poland
NZOZ Holsamed - Oddzial Libero
Katowice, Poland
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Krakow, Poland
Krakowskie Centrum Medyczne Sp. z o.o.
Krakow, Poland
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, Poland
Medrise Sp. z o.o.
Lublin, Poland
Centrum Innowacyjnych Terapii Sp. z o.o.
Mazowieckie, Poland
EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium
Poznan, Poland
Gabinety Lekarskie RIVERMED
Poznan, Poland
Centrum Medyczne Medyk Sp. z 0.0. sp.k.
Rzeszów, Poland
Endoskopia Sp. z.o.o.
Sopot, Poland
Sonomed Sp. z 0.0.
Szczecin, Poland
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.
Szczecin, Poland
Gastromed Sp. z.o.o.
Torun, Poland
H-T Centrum Medyczne - Endoterapia
Tychy, Poland
Bodyclinic Sp. z o.o. sp.k.
Warsaw, Poland
Przychodnia care Access Warsawa
Warsaw, Poland
Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
Warsaw, Poland
FutureMeds Wrocław
Wroclaw, Poland
Centrum Medyczne Oporow
Wroclaw, Poland
Przychodnia Euromedicare szpital euromedicare
Wroclaw, Poland
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
Bucharest, Romania
Spitalul Clinic Colentina
Bucharest, Romania
Institutul Clinic Fundeni
Bucharest, Romania
Centrul Medical Medicum S.R.L.
Bucharest, Romania
Centrul Medical Monza S.R.L
Bucharest, Romania
Spitalul Clinic Judetean De Urgenta Cluj-Napoca
Cluj-Napoca, Romania
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca
Cluj-Napoca, Romania
Gastromed S.R.L
Constanța, Romania
Spitalul Judetean de Urgenta Satu Mare
Satu Mare, Romania
Asociatia Oncohelp
Timișoara, Romania
Centrul De Gastroenterologie Dr. Goldis S.R.L
Timișoara, Romania
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department
Belgrade, Serbia
Clinical Hospital Center "Dr Dragisa Misovic - Dedinje" Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department
Belgrade, Serbia
Clinical Hospital Center "Zvezdara" - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology
Belgrade, Serbia
University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology
Belgrade, Serbia
University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology
Kragujevac, Serbia
General Hospital "Djordje Joanovic" Zrenjanin,Internal Medicine Sector - Internal Department
Zrenjanin, Serbia
Inje University Haeundae Paik Hospital IRB
Busan, South Korea
Kyungpook National University Hospital
Daegu, South Korea
The Catholic University of Korea Daejeon St.Mary's Hospital
Daejeon, South Korea
Kyung Hee University Hospital
Guri-si, South Korea
Kangbuk Samsung Hospital
Jongno-Gu, South Korea
Yeungnam University Hospital
Nam-Gu, South Korea
Hanyang University Seoul Hospital
Seongdong-gu, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
The Catholic University of Korea
Suwon, South Korea
Yonsei University Wonju Severance Christian Hospital
Wŏnju, South Korea
Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol
Ferrol, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
Hospital Universitario Nuestra Senora de Candelaria
Santa Cruz de Tenerife, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
Taichung Veterans General Hospital
Taichung, Taiwan
National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
Taipei, Taiwan
MacKay Memorial Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital (CGMH)
Taoyuan, Taiwan
Southmead Hospital - North Bristol Trust Clinical Research Centre
Bristol, United Kingdom
Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust
Bury, United Kingdom
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
Cambridge, United Kingdom
Synexus Clinical Research Centre
Cardiff, United Kingdom
King's College Hospital
London, United Kingdom
Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
North Shields, United Kingdom