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

Last updated: March 25, 2025
Sponsor: Gilead Sciences
Overall Status: Active - Recruiting

Phase

2

Condition

Colic

Inflammatory Bowel Disease

Crohn's Disease

Treatment

Placebo-to-match GS-1427

Ustekinumab

GS-1427

Clinical Study ID

NCT06290934
GS-US-409-5704
2023-508304-38
  • Ages 18-75
  • All Genders

Study 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 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

Total Participants: 228
Treatment Group(s): 3
Primary Treatment: Placebo-to-match GS-1427
Phase: 2
Study Start date:
March 27, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • Macquarie University

    Sydney, New South Wales 2109
    Australia

    Active - Recruiting

  • Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Princess Alexandra Hospital - Metro South Health

    Woolloongabba, Queensland 4102
    Australia

    Active - Recruiting

  • The Queen Elizabeth Hospital

    Woodville, South Australia 5011
    Australia

    Active - Recruiting

  • Monash Health - Monash Medical Centre

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Northern Hospital - Northern Health

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Saint Vincent's Hospital Melbourne

    Fitzroy, Victoria 3065
    Australia

    Active - Recruiting

  • Footscray Hospital - Westerm Health

    Footscray, Victoria 3011
    Australia

    Active - Recruiting

  • Medical University Innsbruck, University Hospital for Internal Medicine I

    Innsbruck, 6020
    Austria

    Active - Recruiting

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

    Vienna, 1090
    Austria

    Active - Recruiting

  • Imeldaziekenhuis

    Bonheiden, 2820
    Belgium

    Active - Recruiting

  • AZ Groeninge

    Kortrijk, 8500
    Belgium

    Active - Recruiting

  • TDDA Specialty Reserach

    Vaughan, L4L 4Y7
    Canada

    Active - Recruiting

  • Nemocnice Slany

    Slany, 274 01
    Czechia

    Active - Recruiting

  • CHU Nantes Gastroenterology department

    Nantes, 44000
    France

    Active - Recruiting

  • Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology

    Pierre-Benite, 69495
    France

    Active - Recruiting

  • ARENSIA Exploratory Medicine

    Tbilisi, 112
    Georgia

    Active - Recruiting

  • AZ Groeninge

    Halle (Saale), 06108
    Germany

    Active - Recruiting

  • University Hospital Schleswig-Holstein, Clinic for Internal Medicine

    Kiel, 24105
    Germany

    Active - Recruiting

  • Princess Margaret Hospital

    Hong Kong,
    Hong Kong

    Active - Recruiting

  • Queen Mary Hospital

    Hong Kong, 999077
    Hong Kong

    Active - Recruiting

  • Clinexpert Gyógycentrum

    Budapest, 1125
    Hungary

    Active - Recruiting

  • Semmelweis Egyetem Általanos Orvostudományi Kar

    Budapest, 1085
    Hungary

    Active - Recruiting

  • San Raffaele Hospital IRCCS

    Milano, 20089
    Italy

    Active - Recruiting

  • Campus Biomedico University Hospital Foundation

    Roma, 00128
    Italy

    Active - Recruiting

  • Inje University Haeundae Paik Hospital IRB

    Busan, 48108
    Korea, Republic of

    Active - Recruiting

  • Kyungpook National University Hospital

    Daegu, 41944
    Korea, Republic of

    Active - Recruiting

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

    Daejeon, 34943
    Korea, Republic of

    Active - Recruiting

  • Kyung Hee University Hospital

    Guri-Si, 471-701
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samasung Hospital

    Jongno-Gu, 03181
    Korea, Republic of

    Active - Recruiting

  • Kangbuk Samsung Hospital

    Jongno-Gu, 03181
    Korea, Republic of

    Active - Recruiting

  • Yeungnam University Hospital

    Nam-Gu, 42415
    Korea, Republic of

    Active - Recruiting

  • Hanyang University Seoul Hospital

    Seongdong-gu, 4763
    Korea, Republic of

    Active - Recruiting

  • Asan Medical Center

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center

    Seoul, 6351
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 6591
    Korea, Republic of

    Active - Recruiting

  • Yonsei University Wonju Severance Christian Hospital

    Wonju, 220-701
    Korea, Republic of

    Active - Recruiting

  • Hospital Universiti Sains Malaysia

    Kota Bharu, Kelantan 16150
    Malaysia

    Site Not Available

  • Hospital Sultan Idris Shah Serdang

    Kajang, Selangor 43000
    Malaysia

    Site Not Available

  • Hospital Universiti Sains Malaysia

    Kelantan, 16150
    Malaysia

    Active - Recruiting

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586
    Malaysia

    Active - Recruiting

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100
    Malaysia

    Active - Recruiting

  • Sultan Ahmad Shah Medical Centre @IIUM

    Kuantan, 25200
    Malaysia

    Active - Recruiting

  • University Malaya Medical Centre

    Petaling Jaya, 50603
    Malaysia

    Active - Recruiting

  • Hospital Sultan Idris Shah Serdang

    Selangor, 43000
    Malaysia

    Active - Recruiting

  • PMSI Clinical Republican Hospital "Timofei Molneaga"

    Chisinau, MD-2025
    Moldova, Republic of

    Active - Recruiting

  • NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600
    Poland

    Active - Recruiting

  • Endoskopia Sp. z.o.o.

    Kraków, 30-082
    Poland

    Active - Recruiting

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Kraków, 31-501
    Poland

    Active - Recruiting

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

    Ksawerów, 95-054
    Poland

    Active - Recruiting

  • Centrum Innowacyjnych Terapii Sp. z o.o.

    Mazowieckie, 05-500
    Poland

    Active - Recruiting

  • Gabinety Lekarskie RIVERMED

    Poznan, 61-441
    Poland

    Active - Recruiting

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

    Poznań, 60-309
    Poland

    Active - Recruiting

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

    Rzeszów, 35-301
    Poland

    Active - Recruiting

  • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.

    Szczecin, 71-434
    Poland

    Active - Recruiting

  • Gastromed Sp. z.o.o.

    Torun, 87-100
    Poland

    Active - Recruiting

  • H-T Centrum Medyczne - Endoterapia

    Tychy, 43-100
    Poland

    Active - Recruiting

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

    Warsaw, 00-728
    Poland

    Active - Recruiting

  • Przychodnia care Access Warsawa

    Warsaw, 00-719
    Poland

    Active - Recruiting

  • Bodyclinic Sp. z o.o. sp.k.

    Warszawa, 00-332
    Poland

    Active - Recruiting

  • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz

    Warszawa, 03-580
    Poland

    Active - Recruiting

  • Centrum Medyczne Oporow

    Wroclaw, 52416
    Poland

    Active - Recruiting

  • FutureMeds Wrocław

    Wroclaw, 50-008
    Poland

    Site Not Available

  • Przychodnia Euromedicare szpital euromedicare

    Wrocław, 54-144
    Poland

    Active - Recruiting

  • Centrul Medical Monza S.R.L

    Bucharest, 11658
    Romania

    Active - Recruiting

  • Spitalul Clinic Colentina

    Bucuresti, 020125
    Romania

    Active - Recruiting

  • Spitalul Clinic Judetean De Urgenta Cluj-Napoca

    Cluj-Napoca, 3-5
    Romania

    Active - Recruiting

  • Centrul De Gastroenterologie Dr. Goldis S.R.L

    Timisoara, 300002
    Romania

    Active - Recruiting

  • Changhua Christian Hospital

    Changhua City, 505
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • China Medical University Hospital

    Taichung, 404327
    Taiwan

    Active - Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705
    Taiwan

    Active - Recruiting

  • MacKay Memorial Hospital

    Taipei, 10449
    Taiwan

    Active - Recruiting

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

    Taipei, 100
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital

    Taipei, 11217
    Taiwan

    Active - Recruiting

  • Chang Gung Memorial Hospital (CGMH)

    Taoyuan City, 333
    Taiwan

    Active - Recruiting

  • Cambridge University Hospital NHS Trust, Addenbrookes Hospital

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Synexus Clinical Research Centre

    Cardiff, CF159SS
    United Kingdom

    Active - Recruiting

  • Synexus North East Clinical Research Centre

    Hexham, NE46 1QJ
    United Kingdom

    Active - Recruiting

  • Onyx Clinical Research (Clinic Location)

    Peoria, Arizona 85381
    United States

    Active - Recruiting

  • Om Research LLC

    Camarillo, California 93010
    United States

    Active - Recruiting

  • VVCRD Research

    Garden Grove, California 92845
    United States

    Active - Recruiting

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Active - Recruiting

  • US San Diego Health System

    La Jolla, California 92037
    United States

    Active - Recruiting

  • Om Research LLC

    Lancaster, California 93534
    United States

    Active - Recruiting

  • United Medical Doctors

    Murrieta, California 92563
    United States

    Active - Recruiting

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California 94609
    United States

    Active - Recruiting

  • Acclaim Clinical Research

    San Diego, California 92120
    United States

    Active - Recruiting

  • SDG Clinical Research, LLC

    San Diego, California 92103
    United States

    Active - Recruiting

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • United Research Institute LLC

    Hialeah, Florida 33016
    United States

    Active - Recruiting

  • Encore Medical Research. LLC

    Hollywood, Florida 33021
    United States

    Active - Recruiting

  • Advance Research Center

    Miami, Florida 33183
    United States

    Active - Recruiting

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

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Alliance Clinical Research of Tampa, LLC

    New Port Richey, Florida 34653
    United States

    Active - Recruiting

  • Clinical Research of Osceola

    Orlando, Florida 34741
    United States

    Active - Recruiting

  • Digestive and Liver Center of Florida, LLC

    Orlando, Florida 32825
    United States

    Active - Recruiting

  • USF Health Morsani Center for Advanced Healthcare

    Tampa, Florida 33612
    United States

    Active - Recruiting

  • Encore Medical Research of Weston, LLC

    Weston, Florida 33331
    United States

    Active - Recruiting

  • Atlanta Center for Gastroenterology, P.C.

    Decatur, Georgia 30033
    United States

    Active - Recruiting

  • EBGS Clinical Research Center

    Snellville, Georgia 30078
    United States

    Active - Recruiting

  • Louisiana Research Center, LLC

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21224
    United States

    Active - Recruiting

  • Clinical Research Institute of Michigan, LLC.

    Chesterfield, Michigan 48047
    United States

    Active - Recruiting

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

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Gastroenterology Associates of North Mississippi

    Oxford, Mississippi 38655
    United States

    Active - Recruiting

  • Digestive Health Specialists (Clinic Visits)

    Tupelo, Mississippi 38801
    United States

    Active - Recruiting

  • St Charles Clinical Research

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St Charles Clinical Research

    Weldon Spring, Missouri 63304
    United States

    Active - Recruiting

  • N.Y. Total Medical Care, PC

    Brooklyn, New York 11215
    United States

    Active - Recruiting

  • Lenox Hill Hospital

    Manhasset, New York 11030
    United States

    Active - Recruiting

  • NYU Grossman School of Medicne

    New York, New York 10016
    United States

    Active - Recruiting

  • Carolina Research

    Greenville, North Carolina 27834
    United States

    Active - Recruiting

  • Piedmont Healthcare

    Statesville, North Carolina 28625
    United States

    Active - Recruiting

  • Dayton Gastroenterology, LLC

    Beavercreek, Ohio 45440
    United States

    Active - Recruiting

  • Gastro Health Research

    Cincinnati, Ohio 45219
    United States

    Active - Recruiting

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, Ohio 44145
    United States

    Active - Recruiting

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Active - Recruiting

  • Care Access - Pottsville

    Pottsville, Pennsylvania 17901
    United States

    Active - Recruiting

  • Skyline gastroenterology of west Tennessee

    Jackson, Tennessee 38301
    United States

    Active - Recruiting

  • Quality Medical Research

    Nashville, Tennessee 37211
    United States

    Active - Recruiting

  • Vanderbilt Inflammatory Bowel Disease Clinic

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Gastroenterology Research of San Antonio

    Fredericksburg, Texas 78624
    United States

    Active - Recruiting

  • Amel Med Llc

    Georgetown, Texas 78628
    United States

    Active - Recruiting

  • Southwest Clinical Trials

    Houston, Texas 77074
    United States

    Active - Recruiting

  • GI Alliance - Mansfield

    Mansfield, Texas 76063
    United States

    Active - Recruiting

  • Clinical Associates in Research Therapeutics of America, LLC

    San Antonio, Texas 78212
    United States

    Active - Recruiting

  • Southern Star Research Institute, LLC.

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Tyler Research Institute, LLC.

    Tyler, Texas 75701
    United States

    Active - Recruiting

  • University of Virginia Medical Center

    Charlottesville, Virginia 22908
    United States

    Active - Recruiting

  • Emeritas Research Group

    Lansdowne Town Center, Virginia 20176
    United States

    Active - Recruiting

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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