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)
Status: Recruiting
Location: See all (188) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with 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 endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
• Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
• Individuals have an inadequate response or loss of response or are intolerant to \< 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)
Locations
United States
Arizona
Onyx Clinical Research (Clinic Location)
RECRUITING
Peoria
California
Om Research LLC
RECRUITING
Camarillo
VVCRD Research
RECRUITING
Garden Grove
310 Clinical Research
RECRUITING
Inglewood
US San Diego Health System
RECRUITING
La Jolla
Om Research LLC
RECRUITING
Lancaster
United Medical Doctors
RECRUITING
Murrieta
UCSF Benioff Children's Hospital Oakland
RECRUITING
Oakland
University Of California, Davis
RECRUITING
Sacramento
Acclaim Clinical Research
RECRUITING
San Diego
SDG Clinical Research, LLC
RECRUITING
San Diego
Colorado
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Peak Gastroenterology Associates
RECRUITING
Colorado Springs
Florida
Gastro Florida
RECRUITING
Clearwater
Best Quality Research, Inc
RECRUITING
Hialeah
United Research Institute LLC
RECRUITING
Hialeah
Encore Medical Research. LLC
RECRUITING
Hollywood
Advance Research Center
RECRUITING
Miami
Blessed Health Care & Research, Inc
RECRUITING
Miami
Medical Professional Clinical Research Center, Inc.
RECRUITING
Miami
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
RECRUITING
Miami
Alliance Clinical Research of Tampa, LLC
RECRUITING
New Port Richey
Clinical Research of Osceola
RECRUITING
Orlando
Digestive and Liver Center of Florida, LLC
RECRUITING
Orlando
USF Health Morsani Center for Advanced Healthcare
RECRUITING
Tampa
Encore Medical Research of Weston, LLC
RECRUITING
Weston
Georgia
Atlanta Center for Gastroenterology, P.C.
RECRUITING
Decatur
EBGS Clinical Research Center
RECRUITING
Snellville
Illinois
The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)
RECRUITING
Chicago
Onyx Clinical Research
RECRUITING
Peoria
Kentucky
Robley Rex VA Medical Center
RECRUITING
Louisville
Louisiana
Louisiana Research Center, LLC
RECRUITING
Shreveport
Maryland
Johns Hopkins Bayview Medical Center
RECRUITING
Baltimore
Michigan
Clinical Research Institute of Michigan, LLC.
RECRUITING
Chesterfield
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
RECRUITING
Wyoming
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
St Charles Clinical Research
RECRUITING
Weldon Spring
Mississippi
Gastroenterology Associates of North Mississippi
RECRUITING
Oxford
Digestive Health Specialists (Clinic Visits)
RECRUITING
Tupelo
North Carolina
Carolina Research
RECRUITING
Greenville
Piedmont Healthcare
RECRUITING
Statesville
New Jersey
Tandem - Allied Clinical Research, LLC
RECRUITING
Freehold
New York
N.Y. Total Medical Care, PC
RECRUITING
Brooklyn
NYU Langone Long Island Clinical Research Associates
RECRUITING
Great Neck
Lenox Hill Hospital
RECRUITING
Manhasset
NYU Grossman School of Medicne
RECRUITING
New York
Ohio
Dayton Gastroenterology, LLC
RECRUITING
Beavercreek
Gastro Health Research
RECRUITING
Cincinnati
NexGen Research
RECRUITING
Lima
Gastro Intestinal Research Institute of Northern Ohio, LLC
RECRUITING
Westlake
Pennsylvania
Penn State University Milton S. Hershey Medical Center
RECRUITING
Hershey
Care Access - Pottsville
RECRUITING
Pottsville
Tennessee
Skyline gastroenterology of west Tennessee
RECRUITING
Jackson
Quality Medical Research
RECRUITING
Nashville
Vanderbilt Inflammatory Bowel Disease Clinic
RECRUITING
Nashville
Texas
Gastroenterology Research of San Antonio
RECRUITING
Fredericksburg
Amel Med Llc
RECRUITING
Georgetown
Southwest Clinical Trials
RECRUITING
Houston
GI Alliance - Mansfield
RECRUITING
Mansfield
Clinical Associates in Research Therapeutics of America, LLC
RECRUITING
San Antonio
Southern Star Research Institute, LLC.
RECRUITING
San Antonio
Tyler Research Institute, LLC.
RECRUITING
Tyler
Virginia
University of Virginia Medical Center
RECRUITING
Charlottesville
Emeritas Research Group
RECRUITING
Lansdowne Town Center
Gastroenterology Consultants of Southwest Virginia
RECRUITING
Roanoke
Other Locations
Australia
Monash Health - Monash Medical Centre
RECRUITING
Clayton
Northern Hospital - Northern Health
RECRUITING
Epping
Saint Vincent's Hospital Melbourne
RECRUITING
Fitzroy
Footscray Hospital - Westerm Health
RECRUITING
Footscray
Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
RECRUITING
South Brisbane
Macquarie University
RECRUITING
Sydney
The Queen Elizabeth Hospital
RECRUITING
Woodville
Princess Alexandra Hospital - Metro South Health
RECRUITING
Woolloongabba
Austria
Medical University Innsbruck, University Hospital for Internal Medicine I
RECRUITING
Innsbruck
Regional Hospital Salzburg, University Clinic for Internal Medicine I
RECRUITING
Salzburg
Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology
RECRUITING
Vienna
Belgium
Imeldaziekenhuis
RECRUITING
Bonheiden
AZ Groeninge
RECRUITING
Kortrijk
Vitaz
RECRUITING
Sint-niklaas
Canada
TDDA Specialty Reserach
RECRUITING
Vaughan
France
Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D
RECRUITING
La Tronche
CHU Nantes Gastroenterology department
RECRUITING
Nantes
Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology
RECRUITING
Pierre-bénite
Georgia
ARENSIA Exploratory Medicine
RECRUITING
Tbilisi
Germany
Universitatsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik |
RECRUITING
Dresden
Studiengesellschaft BSF UG
RECRUITING
Halle
University Hospital Schleswig-Holstein, Clinic for Internal Medicine
RECRUITING
Kiel
Ulm University Hospital, Centre for Internal Medicine I
RECRUITING
Ulm
Hong Kong Special Administrative Region
Princess Margaret Hospital
RECRUITING
Hong Kong
Queen Mary Hospital
RECRUITING
Hong Kong
Hungary
Clinexpert Gyógycentrum
RECRUITING
Budapest
Semmelweis Egyetem Általanos Orvostudományi Kar
RECRUITING
Budapest
Semmelweis Egyetem AOK
RECRUITING
Budapest
Italy
Azienda Ospedaliero-Universitaria Di Bologna IRCCS
RECRUITING
Bologna
Azienda Ospedaliera Brotzu - P.O. San Michele
RECRUITING
Cagliari
AOU Renato Dulbecco - Digestive Physiopathology Unit
RECRUITING
Catanzaro
San Raffaele Hospital IRCCS
RECRUITING
Milan
IRCCS Ospedale Sacro Cuore Don Calabria
RECRUITING
Negrar
Azienda Ospedale Universita di Padova
RECRUITING
Padua
AOOR Villa Sofia- Cervello
RECRUITING
Palermo
Campus Biomedico University Hospital Foundation
RECRUITING
Roma
Ospedale Sandro Pertini
RECRUITING
Roma
IRCCS Policlinico San Donato
RECRUITING
San Donato Milanese
Ospedale Casa Sollievo della Sofferenza IRCCS, Opera di San Pio da Pietrelcina
RECRUITING
San Giovanni Rotondo
Azienda Ospedaliera Ordine Mauriziano di Torino
RECRUITING
Torino
Malaysia
Hospital Sultanah Aminah
RECRUITING
Johor Bahru
Hospital Universiti Sains Malaysia
RECRUITING
Kelantan
Hospital Queen Elizabeth
RECRUITING
Kota Kinabalu
Hospital Sultan Idris Shah Serdang
RECRUITING
Kuala Selangor
Hospital Tengku Ampuan Afzan
RECRUITING
Kuantan
Sultan Ahmad Shah Medical Centre @IIUM
RECRUITING
Kuantan
University Malaya Medical Centre
RECRUITING
Petaling Jaya
New Zealand
Pacific Clinical Research Network - Auckland
RECRUITING
Auckland
Christchurch Hospital
RECRUITING
Christchurch
Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital
RECRUITING
Dunedin
Poland
Centrum Medyczne Medis
RECRUITING
Bydgoszcz
NZOZ Holsamed - Oddzial Libero
RECRUITING
Katowice
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
RECRUITING
Krakow
Endoskopia Sp. z.o.o.
RECRUITING
Krakow
Krakowskie Centrum Medyczne Sp. z o.o.
RECRUITING
Krakow
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
RECRUITING
Ksawerów
Medrise Sp. z o.o.
RECRUITING
Lublin
Centrum Innowacyjnych Terapii Sp. z o.o.
RECRUITING
Mazowieckie
EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium
RECRUITING
Poznan
Gabinety Lekarskie RIVERMED
RECRUITING
Poznan
Centrum Medyczne Medyk Sp. z 0.0. sp.k.
RECRUITING
Rzeszów
Sonomed Sp. z 0.0.
RECRUITING
Szczecin
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.
RECRUITING
Szczecin
Gastromed Sp. z.o.o.
RECRUITING
Torun
H-T Centrum Medyczne - Endoterapia
RECRUITING
Tychy
Bodyclinic Sp. z o.o. sp.k.
RECRUITING
Warsaw
Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
RECRUITING
Warsaw
Przychodnia care Access Warsawa
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
FutureMeds Wrocław
RECRUITING
Wroclaw
Przychodnia Euromedicare szpital euromedicare
RECRUITING
Wroclaw
Republic of Korea
Inje University Haeundae Paik Hospital IRB
RECRUITING
Busan
Kyungpook National University Hospital
RECRUITING
Daegu
The Catholic University of Korea Daejeon St.Mary's Hospital
RECRUITING
Daejeon
Kyung Hee University Hospital
RECRUITING
Guri-si
Kangbuk Samsung Hospital
RECRUITING
Jongno-gu
Yeungnam University Hospital
RECRUITING
Nam-gu
Hanyang University Seoul Hospital
RECRUITING
Seongdong-gu
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
The Catholic University of Korea, Seoul St. Mary's Hospital
RECRUITING
Seoul
The Catholic University of Korea
RECRUITING
Suwon
Yonsei University Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Republic of Moldova
PMSI Clinical Republican Hospital Timofei Molneaga
RECRUITING
Chisinau
Romania
Centrul Medical Medicum S.R.L.
RECRUITING
Bucharest
Centrul Medical Monza S.R.L
RECRUITING
Bucharest
Institutul Clinic Fundeni
RECRUITING
Bucharest
Spitalul Clinic Colentina
RECRUITING
Bucharest
Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila
RECRUITING
Bucharest
Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca
RECRUITING
Cluj-napoca
Spitalul Clinic Judetean De Urgenta Cluj-Napoca
RECRUITING
Cluj-napoca
Gastromed S.R.L
RECRUITING
Constanța
Spitalul Judetean de Urgenta Satu Mare
RECRUITING
Satu Mare
Asociatia Oncohelp
RECRUITING
Timișoara
Centrul De Gastroenterologie Dr. Goldis S.R.L
RECRUITING
Timișoara
Serbia
Clinical Hospital Center Bezanijska Kosa, Clinic for Internal Medicine, Gastroenterology and Hepatology Department
RECRUITING
Belgrade
Clinical Hospital Center Dr Dragisa Misovic - Dedinje Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department
RECRUITING
Belgrade
Clinical Hospital Center Zvezdara - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology
RECRUITING
Belgrade
University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology
RECRUITING
Belgrade
University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology
RECRUITING
Kragujevac
General Hospital Djordje Joanovic Zrenjanin,Internal Medicine Sector - Internal Department
RECRUITING
Zrenjanin
Spain
Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol
RECRUITING
Ferrol
Hospital Universitario de Cabuenes
RECRUITING
Gijón
Hospital Universitario Juan Ramon Jimenez
RECRUITING
Huelva
Hospital Universitario Nuestra Senora de Candelaria
RECRUITING
Santa Cruz De Tenerife
Hospital Universitario Virgen Macarena
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
RECRUITING
Valencia
Taiwan
Changhua Christian Hospital
RECRUITING
Changhua
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
China Medical University Hospital
RECRUITING
Taichung
Taichung Veterans General Hospital
RECRUITING
Taichung
MacKay Memorial Hospital
RECRUITING
Taipei
National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
RECRUITING
Taipei
Taipei Veterans General Hospital
RECRUITING
Taipei
Chang Gung Memorial Hospital (CGMH)
RECRUITING
Taoyuan
United Kingdom
Southmead Hospital - North Bristol Trust Clinical Research Centre
RECRUITING
Bristol
Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust
RECRUITING
Bury
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
RECRUITING
Cambridge
Synexus Clinical Research Centre
RECRUITING
Cardiff
Synexus North East Clinical Research Centre
RECRUITING
Hexham
King's College Hospital
RECRUITING
London
Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
RECRUITING
North Shields
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2024-03-27
Estimated Completion Date: 2027-07
Participants
Target number of participants: 228
Treatments
Experimental: Part A, Part B, Part C: GS-1427 Dose A
Participants will receive GS-1427 Dose A Day 1 through Week 12 (Part A).~Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).~Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).
Experimental: Part A, Part B, Part C: GS-1427 Dose B
Participants will receive GS-1427 Dose B Day 1 through Week 12 (Part A).~Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).~Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 24 weeks (through Week 76).
Experimental: Part A, Part B, Part C: GS-1427 Dose C
Participants will receive GS-1427 Dose C Day 1 through Week 12 (Part A).~Participants who complete the 12-week Part A treatment period will be eligible to continue and remain on the same dose of GS-1427 through Week 52 (Part B).~Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 24 weeks (through Week 76).
Experimental: Part A, Placebo; Part B, Part C: GS-1427
Participants will receive Placebo to match GS-1427 Day 1 through Week 12 (Part A). Part A placebo participants will be eligible to undergo re-randomization in a double-blind manner after endoscopy assessment at Week 12 to receive one of the GS-1427 dose A, B, or C treatments.~Participants will be eligible to continue and remain on the new dose through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 24 weeks (through Week 76).
Related Therapeutic Areas
Sponsors
Leads: Gilead Sciences