Study Details

OVERVIEW

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) (SWIFT)

PROTOCOL 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.

Participation Requirements

Age

18 Years - 75 Years

Sex

ALL

Healthy Volunteers

Medical Condition

Ulcerative Colitis

Gender

N/A

Date

March 2024 - March 2026

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

GS-1427, Placebo-to-match GS-1427

Eligibility Information

Inclusion Criteria

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)

Exclusion Criteria

Have a current diagnosis of Crohn's Disease (CD) or clinical findings suggestive of CD, diagnosis of indeterminate colitis due to etiologies such as an enteric pathogen, or lymphocytic or collagenous colitis.
Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
Have any history of exposure to vedolizumab or other integrin antagonists
Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol
Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

Locations (182)

Onyx Clinical Research (Clinic Location)

Peoria, Arizona, United States, 85381

Om Research LLC

Camarillo, California, United States, 93010

VVCRD Research

Garden Grove, California, United States, 92845

310 Clinical Research

Inglewood, California, United States, 90301

US San Diego Health System

La Jolla, California, United States, 92037

Om Research LLC

Lancaster, California, United States, 93534

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

University Of California, Davis

Sacramento, California, United States, 95817

SDG Clinical Research, LLC

San Diego, California, United States, 92103

Acclaim Clinical Research

San Diego, California, United States, 92120

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States, 80907

Peak Gastroenterology Associates

Colorado Springs, Colorado, United States, 80921

Gastro Florida

Clearwater, Florida, United States, 33756

Best Quality Research, Inc

Hialeah, Florida, United States, 33016

United Research Institute LLC

Hialeah, Florida, United States, 33016

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy

Miami, Florida, United States, 33136

Medical Professional Clinical Research Center, Inc.

Miami, Florida, United States, 33155

Blessed Health Care & Research, Inc

Miami, Florida, United States, 33173

Alliance Clinical Research of Tampa, LLC

New Port Richey, Florida, United States, 34653

Digestive and Liver Center of Florida, LLC

Orlando, Florida, United States, 32825

Clinical Research of Osceola

Orlando, Florida, United States, 34741

Encore Medical Research of Weston, LLC

Weston, Florida, United States, 33331

EBGS Clinical Research Center

Snellville, Georgia, United States, 30078

The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)

Chicago, Illinois, United States, 60637

Onyx Clinical Research

Peoria, Illinois, United States, 85381

Robley Rex VA Medical Center

Louisville, Kentucky, United States, 40206

Louisiana Research Center, LLC

Shreveport, Louisiana, United States, 71105

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.

Wyoming, Michigan, United States, 49519

Mayo Clinic

Rochester, Minnesota, United States, 55905

Gastroenterology Associates of North Mississippi

Oxford, Mississippi, United States, 38655

Digestive Health Specialists (Clinic Visits)

Tupelo, Mississippi, United States, 38801

St Charles Clinical Research

Weldon Spring, Missouri, United States, 63304

Tandem - Allied Clinical Research, LLC

Freehold, New Jersey, United States, 07728

N.Y. Total Medical Care, PC

Brooklyn, New York, United States, 11215

NYU Langone Long Island Clinical Research Associates

Great Neck, New York, United States, 11021

Lenox Hill Hospital

Manhasset, New York, United States, 11030

NYU Grossman School of Medicne

New York, New York, United States, 10016

Carolina Research

Greenville, North Carolina, United States, 27834

Piedmont Healthcare

Statesville, North Carolina, United States, 28625

Dayton Gastroenterology, LLC

Beavercreek, Ohio, United States, 45440

Gastro Health Research

Cincinnati, Ohio, United States, 45219

NexGen Research

Lima, Ohio, United States, 45801

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio, United States, 44145

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Skyline gastroenterology of west Tennessee

Jackson, Tennessee, United States, 38301

Quality Medical Research

Nashville, Tennessee, United States, 37211

Vanderbilt Inflammatory Bowel Disease Clinic

Nashville, Tennessee, United States, 37232

Gastroenterology Research of San Antonio

Fredericksburg, Texas, United States, 78624

Amel Med Llc

Georgetown, Texas, United States, 78628

GI Alliance - Mansfield

Mansfield, Texas, United States, 76063

Clinical Associates in Research Therapeutics of America, LLC

San Antonio, Texas, United States, 78212

Southern Star Research Institute, LLC.

San Antonio, Texas, United States, 78229

Tyler Research Institute, LLC.

Tyler, Texas, United States, 75701

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22908

Emeritas Research Group

Lansdowne Town Center, Virginia, United States, 20176

Gastroenterology Consultants of Southwest Virginia

Roanoke, Virginia, United States, 24014

Macquarie University

Sydney, New South Wales, Australia, 2109

Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd

South Brisbane, Queensland, Australia, 4101

Princess Alexandra Hospital - Metro South Health

Woolloongabba, Queensland, Australia, 4102

The Queen Elizabeth Hospital

Woodville, South Australia, Australia, 5011

Monash Health - Monash Medical Centre

Clayton, Victoria, Australia, 3168

Northern Hospital - Northern Health

Epping, Victoria, Australia, 3076

Saint Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Footscray Hospital - Westerm Health

Footscray, Victoria, Australia, 3011

Medical University Innsbruck, University Hospital for Internal Medicine I

Innsbruck, Austria, 6020

Regional Hospital Salzburg, University Clinic for Internal Medicine I

Salzburg, Austria, A-5020

Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology

Vienna, Austria, 1090

Imeldaziekenhuis

Bonheiden, Belgium, 2820

AZ Groeninge

Kortrijk, Belgium, 8500

Vitaz

Sint-Niklaas, Belgium, 9100

TDDA Specialty Reserach

Vaughan, Canada, L4L 4Y7

PreventaMed, s.r.o.

Olomouc, Czechia, 779 00

Nemocnice Slany

Slaný, Czechia, 274 01

Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D

La Tronche, France, 38700

CHU Nantes Gastroenterology department

Nantes, France, 44000

Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology

Pierre-Bénite, France, 69495

ARENSIA Exploratory Medicine

Tbilisi, Georgia, 112

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik |

Dresden, Germany, 01307

Studiengesellschaft BSF UG

Halle, Germany, 06108

University Hospital Schleswig-Holstein, Clinic for Internal Medicine

Kiel, Germany, 24105

Ulm University Hospital, Centre for Internal Medicine I

Ulm, Germany, 89081

Queen Mary Hospital

Hong Kong, Hong Kong, 999077

Princess Margaret Hospital

Hong Kong, Hong Kong

Békés Varmegye Kozponti Korhaz, dr Rethy Pal 4. Belgyégyaszat - Gasztroenterologia

Békéscsaba, Hungary, 5600

Semmelweis Egyetem AOK

Budapest, Hungary, 1085

Semmelweis Egyetem Általanos Orvostudományi Kar

Budapest, Hungary, 1085

Clinexpert Gyógycentrum

Budapest, Hungary, 1125

Azienda Ospedaliero-Universitaria Di Bologna IRCCS

Bologna, Italy, 40138

Azienda Ospedaliera Brotzu - P.O. San Michele

Cagliari, Italy, 09047

AOU "Renato Dulbecco" - Digestive Physiopathology Unit

Catanzaro, Italy, 88100

San Raffaele Hospital IRCCS

Milan, Italy, 20089

IRCCS Ospedale Sacro Cuore Don Calabria

Negrar, Italy, 37024

Azienda Ospedale Universita di Padova

Padua, Italy, 35100

AOOR Villa Sofia- Cervello

Palermo, Italy, 90146

Campus Biomedico University Hospital Foundation

Roma, Italy, 00128

Ospedale Sandro Pertini

Roma, Italy, 157

IRCCS Policlinico San Donato

San Donato Milanese, Italy, 20097

Ospedale Casa Sollievo della Sofferenza IRCCS, Opera di San Pio da Pietrelcina

San Giovanni Rotondo, Italy, 71013

Azienda Ospedaliera Ordine Mauriziano di Torino

Torino, Italy, 10128

Hospital Sultanah Aminah

Johor Bahru, Malaysia, 80100

Hospital Universiti Sains Malaysia

Kelantan, Malaysia, 16150

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia, 88586

Hospital Sultan Idris Shah Serdang

Kuala Selangor, Malaysia, 43000

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia, 25100

Sultan Ahmad Shah Medical Centre @IIUM

Kuantan, Malaysia, 25200

University Malaya Medical Centre

Petaling Jaya, Malaysia, 50603

PMSI Clinical Republican Hospital "Timofei Molneaga"

Chisinau, Moldova, MD-2025

Pacific Clinical Research Network - Auckland

Auckland, New Zealand, 0622

Christchurch Hospital

Christchurch, New Zealand, 8011

Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital

Dunedin, New Zealand, 9012

Centrum Medyczne "Medis"

Bydgoszcz, Poland, 85-168

NZOZ Holsamed - Oddzial Libero

Katowice, Poland, 40-600

Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.

Krakow, Poland, 30-363

Krakowskie Centrum Medyczne Sp. z o.o.

Krakow, Poland, 31-501

Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.

Ksawerów, Poland, 95-054

Medrise Sp. z o.o.

Lublin, Poland, 20-582

Centrum Innowacyjnych Terapii Sp. z o.o.

Mazowieckie, Poland, 05-500

EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium

Poznan, Poland, 60-309

Gabinety Lekarskie RIVERMED

Poznan, Poland, 61-441

Centrum Medyczne Medyk Sp. z 0.0. sp.k.

Rzeszów, Poland, 35-301

Endoskopia Sp. z.o.o.

Sopot, Poland, 81-756

Sonomed Sp. z 0.0.

Szczecin, Poland, 70-361

Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.

Szczecin, Poland, 71-434

Gastromed Sp. z.o.o.

Torun, Poland, 87-100

H-T Centrum Medyczne - Endoterapia

Tychy, Poland, 43-100

Bodyclinic Sp. z o.o. sp.k.

Warsaw, Poland, 00-332

Przychodnia care Access Warsawa

Warsaw, Poland, 00-719

Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland, 00-728

Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz

Warsaw, Poland, 03-580

FutureMeds Wrocław

Wroclaw, Poland, 50-008

Centrum Medyczne Oporow

Wroclaw, Poland, 52416

Przychodnia Euromedicare szpital euromedicare

Wroclaw, Poland, 54-144

Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila

Bucharest, Romania, 010825

Spitalul Clinic Colentina

Bucharest, Romania, 020125

Institutul Clinic Fundeni

Bucharest, Romania, 022328

Centrul Medical Medicum S.R.L.

Bucharest, Romania, 031864

Centrul Medical Monza S.R.L

Bucharest, Romania, 11658

Spitalul Clinic Judetean De Urgenta Cluj-Napoca

Cluj-Napoca, Romania, 3-5

Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca

Cluj-Napoca, Romania, 400132

Gastromed S.R.L

Constanța, Romania, 900178

Spitalul Judetean de Urgenta Satu Mare

Satu Mare, Romania, 440055

Asociatia Oncohelp

Timișoara, Romania, 300002

Centrul De Gastroenterologie Dr. Goldis S.R.L

Timișoara, Romania, 300002

Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department

Belgrade, Serbia, 11000

Clinical Hospital Center "Dr Dragisa Misovic - Dedinje" Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department

Belgrade, Serbia, 11000

Clinical Hospital Center "Zvezdara" - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology

Belgrade, Serbia, 11000

University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology

Belgrade, Serbia, 112108

University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology

Kragujevac, Serbia, 34000

General Hospital "Djordje Joanovic" Zrenjanin,Internal Medicine Sector - Internal Department

Zrenjanin, Serbia, 23000

Inje University Haeundae Paik Hospital IRB

Busan, South Korea, 48108

Kyungpook National University Hospital

Daegu, South Korea, 41944

The Catholic University of Korea Daejeon St.Mary's Hospital

Daejeon, South Korea, 34943

Kyung Hee University Hospital

Guri-si, South Korea, 471-701

Kangbuk Samsung Hospital

Jongno-Gu, South Korea, 03181

Yeungnam University Hospital

Nam-Gu, South Korea, 42415

Hanyang University Seoul Hospital

Seongdong-gu, South Korea, 4763

Asan Medical Center

Seoul, South Korea, 05505

Samsung Medical Center

Seoul, South Korea, 6351

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea, 6591

The Catholic University of Korea

Suwon, South Korea, 16247

Yonsei University Wonju Severance Christian Hospital

Wŏnju, South Korea, 220-701

Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol

Ferrol, Spain, 15405

Hospital Universitario de Cabuenes

Gijón, Spain, 33394

Hospital Universitario Juan Ramon Jimenez

Huelva, Spain, 21005

Hospital Universitario Nuestra Senora de Candelaria

Santa Cruz de Tenerife, Spain, 38010

Hospital Universitario Virgen Macarena

Seville, Spain, 41009

Hospital Universitari i Politecnic La Fe

Valencia, Spain, 46026

Changhua Christian Hospital

Changhua, Taiwan, 505

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan, 807

China Medical University Hospital

Taichung, Taiwan, 404327

Taichung Veterans General Hospital

Taichung, Taiwan, 40705

National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100

Taipei, Taiwan, 100

MacKay Memorial Hospital

Taipei, Taiwan, 10449

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Chang Gung Memorial Hospital (CGMH)

Taoyuan, Taiwan, 333

Southmead Hospital - North Bristol Trust Clinical Research Centre

Bristol, United Kingdom, BS10 5NB

Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust

Bury, United Kingdom, BL9 7TD

Cambridge University Hospital NHS Trust, Addenbrookes Hospital

Cambridge, United Kingdom, CB2 0QQ

Synexus Clinical Research Centre

Cardiff, United Kingdom, CF159SS

King's College Hospital

London, United Kingdom, SE5 9RS

Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital

North Shields, United Kingdom, NE29 8NH

Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis (SWIFT)

OVERVIEW

PROTOCOL SUMMARY

Participation Requirements

Eligibility Information

Inclusion Criteria

Exclusion Criteria

Locations

Locations (182)

Onyx Clinical Research (Clinic Location)

Om Research LLC

VVCRD Research

310 Clinical Research

US San Diego Health System

Om Research LLC

UCSF Benioff Children's Hospital Oakland

University Of California, Davis

SDG Clinical Research, LLC

Acclaim Clinical Research

Peak Gastroenterology Associates

Peak Gastroenterology Associates

Gastro Florida

Best Quality Research, Inc

United Research Institute LLC

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy

Medical Professional Clinical Research Center, Inc.

Blessed Health Care & Research, Inc

Alliance Clinical Research of Tampa, LLC

Digestive and Liver Center of Florida, LLC

Clinical Research of Osceola

Encore Medical Research of Weston, LLC

EBGS Clinical Research Center

The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)

Onyx Clinical Research

Robley Rex VA Medical Center

Louisiana Research Center, LLC

Johns Hopkins Bayview Medical Center

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.

Mayo Clinic

Gastroenterology Associates of North Mississippi

Digestive Health Specialists (Clinic Visits)

St Charles Clinical Research

Tandem - Allied Clinical Research, LLC

N.Y. Total Medical Care, PC

NYU Langone Long Island Clinical Research Associates

Lenox Hill Hospital

NYU Grossman School of Medicne

Carolina Research

Piedmont Healthcare

Dayton Gastroenterology, LLC

Gastro Health Research

NexGen Research

Gastro Intestinal Research Institute of Northern Ohio, LLC

Penn State University Milton S. Hershey Medical Center

Skyline gastroenterology of west Tennessee

Quality Medical Research

Vanderbilt Inflammatory Bowel Disease Clinic

Gastroenterology Research of San Antonio

Amel Med Llc

GI Alliance - Mansfield

Clinical Associates in Research Therapeutics of America, LLC

Southern Star Research Institute, LLC.

Tyler Research Institute, LLC.

University of Virginia Medical Center

Emeritas Research Group

Gastroenterology Consultants of Southwest Virginia

Macquarie University

Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd

Princess Alexandra Hospital - Metro South Health

The Queen Elizabeth Hospital

Monash Health - Monash Medical Centre

Northern Hospital - Northern Health

Saint Vincent's Hospital Melbourne

Footscray Hospital - Westerm Health

Medical University Innsbruck, University Hospital for Internal Medicine I

Regional Hospital Salzburg, University Clinic for Internal Medicine I

Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology

Imeldaziekenhuis

AZ Groeninge