NCT06290934Active, not recruitingPhase 2
Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
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)
Source: ClinicalTrials.gov · Last updated 9 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 228 (estimated)
- First submitted
- 16 Feb 2024
- Start date
- Mar 2024
- Primary completion date
- Mar 2026
- Lead sponsor
- Gilead Sciences
- Diseases
- Ulcerative colitis
- NCT number
- NCT06290934
- EU CT number
- 2023-508304-38-00
- EudraCT number
- 2023-508304-38
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 228
- From Mar 2024 to the primary completion date, Mar 2026
- 156 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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 any history of exposure to vedolizumab or other integrin antagonists
Other
- Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
Who the study is looking for
- 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)
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (156)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH Coordinator of this site? Confirm its status | Salzburg | Austria | Active, not recruiting |
| Monash Health (Monash Medical Centre) Coordinator of this site? Confirm its status | Clayton | Australia | Unknown status |
| Northern Hospital - Northern Health Coordinator of this site? Confirm its status | Epping | Australia | Unknown status |
| Saint Vincent's Hospital Melbourne Coordinator of this site? Confirm its status | Fitzroy | Australia | Unknown status |
| Footscray Hospital - Westerm Health Coordinator of this site? Confirm its status | Footscray | Australia | Unknown status |
| Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd Coordinator of this site? Confirm its status | South Brisbane | Australia | Unknown status |
| Macquarie University Coordinator of this site? Confirm its status | Sydney | Australia | Unknown status |
| The Queen Elizabeth Hospital Coordinator of this site? Confirm its status | Woodville | Australia | Unknown status |
| Princess Alexandra Hospital | Metro South Health Coordinator of this site? Confirm its status | Woolloongabba | Australia | Unknown status |
| Imelda Coordinator of this site? Confirm its status | Bonheiden | Belgium | Completed |
| Algemeen Ziekenhuis Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Completed |
| Vitaz Coordinator of this site? Confirm its status | Sint-Niklaas | Belgium | Completed |
| TDDA Specialty Reserach Coordinator of this site? Confirm its status | Vaughan | Canada | Unknown status |
| PreventaMed, s.r.o. Coordinator of this site? Confirm its status | Olomouc | Czechia | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Kiel | Germany | Active, not recruiting |
| Hospital Universitario Juan Ramon Jimenez Coordinator of this site? Confirm its status | Huelva | Spain | Active, not recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Active, not recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Active, not recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Pierre-Bénite | France | Active, not recruiting |
| Southmead Hospital - North Bristol Trust Clinical Research Centre Coordinator of this site? Confirm its status | Bristol | United Kingdom | Unknown status |
| Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust Coordinator of this site? Confirm its status | Bury | United Kingdom | Unknown status |
| Cambridge University Hospital NHS Trust, Addenbrookes Hospital Coordinator of this site? Confirm its status | Cambridge | United Kingdom | Unknown status |
| Synexus Clinical Research Centre Coordinator of this site? Confirm its status | Cardiff | United Kingdom | Unknown status |
| King's College Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital Coordinator of this site? Confirm its status | North Shields | United Kingdom | Unknown status |
| Arensia Exploratory Medicine Coordinator of this site? Confirm its status | Tbilisi | Georgia | Unknown status |
| Princess Margaret Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Bekes Varmegyei Koezponti Korhaz Coordinator of this site? Confirm its status | Bekescsaba | Hungary | Completed |
| Clinexpert Kft. Coordinator of this site? Confirm its status | Budapest III | Hungary | Completed |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| Vasutegeszseguegyi Nonprofit Koezhasznu Kft. Coordinator of this site? Confirm its status | Debrecen | Hungary | Completed |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliera di Padova Coordinator of this site? Confirm its status | Padova | Italy | Active, not recruiting |
| Inje University Haeundae Paik Hospital IRB Coordinator of this site? Confirm its status | Busan | South Korea | Unknown status |
| Kyungpook National University Hospital Coordinator of this site? Confirm its status | Daegu | South Korea | Unknown status |
| The Catholic University of Korea, Daejeon ST.Mary's Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Kyung Hee University Hospital Coordinator of this site? Confirm its status | Guri-si | South Korea | Unknown status |
| Kangbuk Samsung Hospital Coordinator of this site? Confirm its status | Jongno-Gu | South Korea | Unknown status |
| Yeungnam University Hospital Coordinator of this site? Confirm its status | Nam-Gu | South Korea | Unknown status |
| Hanyang University Seoul Hospital Coordinator of this site? Confirm its status | Seongdong-gu | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea, Seoul ST. Mary's Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| The Catholic University of Korea Coordinator of this site? Confirm its status | Suwon | South Korea | Unknown status |
| Yonsei University Wonju Severance Christian Hospital Coordinator of this site? Confirm its status | Wŏnju | South Korea | Unknown status |
| PMSI Clinical Republican Hospital "Timofei Molneaga" Coordinator of this site? Confirm its status | Chisinau | Moldova | Unknown status |
| Hospital Sultanah Aminah Coordinator of this site? Confirm its status | Johor Bahru | Malaysia | Unknown status |
| Hospital Universiti Sains Malaysia Coordinator of this site? Confirm its status | Kelantan | Malaysia | Unknown status |
| Hospital Queen Elizabeth Coordinator of this site? Confirm its status | Kota Kinabalu | Malaysia | Unknown status |
| Hospital Sultan Idris Shah Serdang Coordinator of this site? Confirm its status | Kuala Selangor | Malaysia | Unknown status |
| Sultan Ahmad Shah Medical Centre IIUM Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| Hospital Tengku Ampuan Afzan Coordinator of this site? Confirm its status | Kuantan | Malaysia | Unknown status |
| University Malaya Medical Centre Coordinator of this site? Confirm its status | Petaling Jaya | Malaysia | Unknown status |
| Pacific Clinical Research Network - Auckland Coordinator of this site? Confirm its status | Auckland | New Zealand | Unknown status |
| Christchurch Hospital Coordinator of this site? Confirm its status | Christchurch | New Zealand | Unknown status |
| Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital Coordinator of this site? Confirm its status | Dunedin | New Zealand | Unknown status |
| Manermed Sp. z o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Gyncentrum Sp. z o.o. Coordinator of this site? Confirm its status | Katowice | Poland | Active, not recruiting |
| Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j. Coordinator of this site? Confirm its status | Ksawerów | Poland | Active, not recruiting |
| Medrise Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Centrum Innowacyjnych Terapii Sp. z o.o. Coordinator of this site? Confirm its status | Piaseczno | Poland | Active, not recruiting |
| Rivermed Sp. z o.o. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Poznan | Poland | Active, not recruiting |
| Centrum Medyczne Medyk Sp. z o.o. Coordinator of this site? Confirm its status | Rzeszow | Poland | Active, not recruiting |
| Endoskopia Sp z o.o. Coordinator of this site? Confirm its status | Sopot | Poland | Active, not recruiting |
| Sonomed Sp. z o.o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o. Coordinator of this site? Confirm its status | Szczecin | Poland | Active, not recruiting |
| H-T Centrum Medyczne Endoterapia Coordinator of this site? Confirm its status | Tychy | Poland | Active, not recruiting |
| Medical Network Sp z o o Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Care Access Polska Sp. Z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Bodyclinic sp. z o.o. sp.k. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Vivamed Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Active, not recruiting |
| Futuremeds Sp. z o.o. Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| EMC Instytut Medyczny S.A. Coordinator of this site? Confirm its status | Wrocław | Poland | Active, not recruiting |
| Institutul Clinic Fundeni Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila' Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Colentina Bucuresti Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Centrul Medical Monza S.R.L Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Spitalul Clinic Judetean De Urgenta Cluj Coordinator of this site? Confirm its status | Cluj-Napoca | Romania | Active, not recruiting |
| Spital Judetean De Urgenta Satu Mare Coordinator of this site? Confirm its status | Satu Mare | Romania | Active, not recruiting |
| Centrul De Gastroenterologie Dr. Goldis S.R.L Coordinator of this site? Confirm its status | Timișoara | Romania | Active, not recruiting |
| Asociatia Oncohelp Coordinator of this site? Confirm its status | Timișoara | Romania | Active, not recruiting |
| Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Hospital Center "Dr Dragisa Misovic - Dedinje" Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Clinical Hospital Center "Zvezdara" - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology Coordinator of this site? Confirm its status | Kragujevac | Serbia | Unknown status |
| General Hospital "Djordje Joanovic" Zrenjanin,Internal Medicine Sector - Internal Department Coordinator of this site? Confirm its status | Zrenjanin | Serbia | Unknown status |
| Changhua Christian Hospital Coordinator of this site? Confirm its status | Changhua | Taiwan | Unknown status |
| Kaohsiung Medical University Chung-Ho Memorial Hospital Coordinator of this site? Confirm its status | Kaohsiung City | Taiwan | Unknown status |
| China Medical University Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taichung Veterans General Hospital Coordinator of this site? Confirm its status | Taichung | Taiwan | Unknown status |
| Taipei Veterans General Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| MacKay Memorial Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100 Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
| Chang Gung Memorial Hospital (CGMH) Coordinator of this site? Confirm its status | Taoyuan City | Taiwan | Unknown status |
| Johns Hopkins Bayview Medical Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| Dayton Gastroenterology, LLC Coordinator of this site? Confirm its status | Beavercreek | United States | Unknown status |
| N.Y. Total Medical Care, PC Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
| Om Research LLC Coordinator of this site? Confirm its status | Camarillo | United States | Unknown status |
| University of Virginia Medical Center Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| The University of Chicago Medical Center - Duchossois Center for Advanced Medicine Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Gastro Health Research Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Gastro Florida Coordinator of this site? Confirm its status | Clearwater | United States | Unknown status |
| Peak Gastroenterology Associates Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Gastroenterology Research of San Antonio Coordinator of this site? Confirm its status | Fredericksburg | United States | Unknown status |
| Tandem - Allied Clinical Research, LLC Coordinator of this site? Confirm its status | Freehold | United States | Unknown status |
| VVCRD Research Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Amel Med LLC Coordinator of this site? Confirm its status | Georgetown | United States | Unknown status |
| NYU Langone Long Island Clinical Research Associates Coordinator of this site? Confirm its status | Great Neck | United States | Unknown status |
| Carolina Research Coordinator of this site? Confirm its status | Greenville | United States | Unknown status |
| Penn State University Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
| Best Quality Research, Inc Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| United Research Institute LLC Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| 310 Clinical Research Coordinator of this site? Confirm its status | Inglewood | United States | Unknown status |
| Skyline Gastroenterology of West Tennessee Coordinator of this site? Confirm its status | Jackson | United States | Unknown status |
| US San Diego Health System Coordinator of this site? Confirm its status | La Jolla | United States | Unknown status |
| Om Research LLC Coordinator of this site? Confirm its status | Lancaster | United States | Unknown status |
| Emeritas Research Group Coordinator of this site? Confirm its status | Lansdowne Town Center | United States | Unknown status |
| NexGen Research Coordinator of this site? Confirm its status | Lima | United States | Unknown status |
| Robley Rex VA Medical Center Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Lenox Hill Hospital Coordinator of this site? Confirm its status | Manhasset | United States | Unknown status |
| GI Alliance - Mansfield Coordinator of this site? Confirm its status | Mansfield | United States | Unknown status |
| University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Medical Professional Clinical Research Center, Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Blessed Health Care & Research, Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Quality Medical Research Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Vanderbilt Inflammatory Bowel Disease Clinic Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Alliance Clinical Research of Tampa, LLC Coordinator of this site? Confirm its status | New Port Richey | United States | Unknown status |
| NYU Grossman School of Medicne Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| UCSF Benioff Children's Hospital Oakland Coordinator of this site? Confirm its status | Oakland | United States | Unknown status |
| Clinical Research of Osceola Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Digestive and Liver Center of Florida, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Gastroenterology Associates of North Mississippi Coordinator of this site? Confirm its status | Oxford | United States | Unknown status |
| Onyx Clinical Research (Clinic Location) Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Onyx Clinical Research Coordinator of this site? Confirm its status | Peoria | United States | Unknown status |
| Gastroenterology Consultants of Southwest Virginia Coordinator of this site? Confirm its status | Roanoke | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| University of California - Davis Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
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| Southern Star Research Institute, LLC Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Acclaim Clinical Research Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| SDG Clinical Research, LLC Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| Louisiana Research Center, LLC Coordinator of this site? Confirm its status | Shreveport | United States | Unknown status |
| EBGS Clinical Research Center Coordinator of this site? Confirm its status | Snellville | United States | Unknown status |
| Piedmont Healthcare Coordinator of this site? Confirm its status | Statesville | United States | Unknown status |
| Digestive Health Specialists (Clinic Visits) Coordinator of this site? Confirm its status | Tupelo | United States | Unknown status |
| Tyler Research Institute, LLC Coordinator of this site? Confirm its status | Tyler | United States | Unknown status |
| St. Charles Clinical Research Coordinator of this site? Confirm its status | Weldon Spring | United States | Unknown status |
| Gastro Intestinal Research Institute of Northern Ohio, LLC Coordinator of this site? Confirm its status | Westlake | United States | Unknown status |
| Encore Medical Research of Weston, LLC Coordinator of this site? Confirm its status | Weston | United States | Unknown status |
| Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center Coordinator of this site? Confirm its status | Wyoming | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.