Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (156)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Gemeinnutzige Salzburger Landes kliniken Betriebsgesellschaft mbH
Coordinator of this site? Confirm its status
SalzburgAustriaActive, not recruiting
Monash Health (Monash Medical Centre)
Coordinator of this site? Confirm its status
ClaytonAustraliaUnknown status
Northern Hospital - Northern Health
Coordinator of this site? Confirm its status
EppingAustraliaUnknown status
Saint Vincent's Hospital Melbourne
Coordinator of this site? Confirm its status
FitzroyAustraliaUnknown status
Footscray Hospital - Westerm Health
Coordinator of this site? Confirm its status
FootscrayAustraliaUnknown status
Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
Coordinator of this site? Confirm its status
South BrisbaneAustraliaUnknown status
Macquarie University
Coordinator of this site? Confirm its status
SydneyAustraliaUnknown status
The Queen Elizabeth Hospital
Coordinator of this site? Confirm its status
WoodvilleAustraliaUnknown status
Princess Alexandra Hospital | Metro South Health
Coordinator of this site? Confirm its status
WoolloongabbaAustraliaUnknown status
Imelda
Coordinator of this site? Confirm its status
BonheidenBelgiumCompleted
Algemeen Ziekenhuis Groeninge
Coordinator of this site? Confirm its status
KortrijkBelgiumCompleted
Vitaz
Coordinator of this site? Confirm its status
Sint-NiklaasBelgiumCompleted
TDDA Specialty Reserach
Coordinator of this site? Confirm its status
VaughanCanadaUnknown status
PreventaMed, s.r.o.
Coordinator of this site? Confirm its status
OlomoucCzechiaActive, not recruiting
Universitaetsklinikum Schleswig-Holstein AöR
Coordinator of this site? Confirm its status
KielGermanyActive, not recruiting
Hospital Universitario Juan Ramon Jimenez
Coordinator of this site? Confirm its status
HuelvaSpainActive, not recruiting
Hospital Universitario Virgen De La Macarena
Coordinator of this site? Confirm its status
SevillaSpainActive, not recruiting
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceActive, not recruiting
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceActive, not recruiting
Southmead Hospital - North Bristol Trust Clinical Research Centre
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust
Coordinator of this site? Confirm its status
BuryUnited KingdomUnknown status
Cambridge University Hospital NHS Trust, Addenbrookes Hospital
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Synexus Clinical Research Centre
Coordinator of this site? Confirm its status
CardiffUnited KingdomUnknown status
King's College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
Coordinator of this site? Confirm its status
North ShieldsUnited KingdomUnknown status
Arensia Exploratory Medicine
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Princess Margaret Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Queen Mary Hospital
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Bekes Varmegyei Koezponti Korhaz
Coordinator of this site? Confirm its status
BekescsabaHungaryCompleted
Clinexpert Kft.
Coordinator of this site? Confirm its status
Budapest IIIHungaryCompleted
Semmelweis University
Coordinator of this site? Confirm its status
Budapest VIIIHungaryCompleted
Vasutegeszseguegyi Nonprofit Koezhasznu Kft.
Coordinator of this site? Confirm its status
DebrecenHungaryCompleted
Ospedale San Raffaele S.r.l.
Coordinator of this site? Confirm its status
MilanItalyActive, not recruiting
Azienda Ospedaliera di Padova
Coordinator of this site? Confirm its status
PadovaItalyActive, not recruiting
Inje University Haeundae Paik Hospital IRB
Coordinator of this site? Confirm its status
BusanSouth KoreaUnknown status
Kyungpook National University Hospital
Coordinator of this site? Confirm its status
DaeguSouth KoreaUnknown status
The Catholic University of Korea, Daejeon ST.Mary's Hospital
Coordinator of this site? Confirm its status
DaejeonSouth KoreaUnknown status
Kyung Hee University Hospital
Coordinator of this site? Confirm its status
Guri-siSouth KoreaUnknown status
Kangbuk Samsung Hospital
Coordinator of this site? Confirm its status
Jongno-GuSouth KoreaUnknown status
Yeungnam University Hospital
Coordinator of this site? Confirm its status
Nam-GuSouth KoreaUnknown status
Hanyang University Seoul Hospital
Coordinator of this site? Confirm its status
Seongdong-guSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
The Catholic University of Korea, Seoul ST. Mary's Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
The Catholic University of Korea
Coordinator of this site? Confirm its status
SuwonSouth KoreaUnknown status
Yonsei University Wonju Severance Christian Hospital
Coordinator of this site? Confirm its status
WŏnjuSouth KoreaUnknown status
PMSI Clinical Republican Hospital "Timofei Molneaga"
Coordinator of this site? Confirm its status
ChisinauMoldovaUnknown status
Hospital Sultanah Aminah
Coordinator of this site? Confirm its status
Johor BahruMalaysiaUnknown status
Hospital Universiti Sains Malaysia
Coordinator of this site? Confirm its status
KelantanMalaysiaUnknown status
Hospital Queen Elizabeth
Coordinator of this site? Confirm its status
Kota KinabaluMalaysiaUnknown status
Hospital Sultan Idris Shah Serdang
Coordinator of this site? Confirm its status
Kuala SelangorMalaysiaUnknown status
Sultan Ahmad Shah Medical Centre IIUM
Coordinator of this site? Confirm its status
KuantanMalaysiaUnknown status
Hospital Tengku Ampuan Afzan
Coordinator of this site? Confirm its status
KuantanMalaysiaUnknown status
University Malaya Medical Centre
Coordinator of this site? Confirm its status
Petaling JayaMalaysiaUnknown status
Pacific Clinical Research Network - Auckland
Coordinator of this site? Confirm its status
AucklandNew ZealandUnknown status
Christchurch Hospital
Coordinator of this site? Confirm its status
ChristchurchNew ZealandUnknown status
Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital
Coordinator of this site? Confirm its status
DunedinNew ZealandUnknown status
Manermed Sp. z o.o.
Coordinator of this site? Confirm its status
BydgoszczPolandActive, not recruiting
Futuremeds Sp. z o.o.
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
Coordinator of this site? Confirm its status
CracowPolandActive, not recruiting
Gyncentrum Sp. z o.o.
Coordinator of this site? Confirm its status
KatowicePolandActive, not recruiting
Centrum Opieki Zdrowotnej Orkan-Med Stec - Michalska Sp. j.
Coordinator of this site? Confirm its status
KsawerówPolandActive, not recruiting
Medrise Sp. z o.o.
Coordinator of this site? Confirm its status
LublinPolandActive, not recruiting
Centrum Innowacyjnych Terapii Sp. z o.o.
Coordinator of this site? Confirm its status
PiasecznoPolandActive, not recruiting
Rivermed Sp. z o.o.
Coordinator of this site? Confirm its status
PoznanPolandActive, not recruiting
EMC Instytut Medyczny S.A.
Coordinator of this site? Confirm its status
PoznanPolandActive, not recruiting
Centrum Medyczne Medyk Sp. z o.o.
Coordinator of this site? Confirm its status
RzeszowPolandActive, not recruiting
Endoskopia Sp z o.o.
Coordinator of this site? Confirm its status
SopotPolandActive, not recruiting
Sonomed Sp. z o.o.
Coordinator of this site? Confirm its status
SzczecinPolandActive, not recruiting
Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.
Coordinator of this site? Confirm its status
SzczecinPolandActive, not recruiting
H-T Centrum Medyczne Endoterapia
Coordinator of this site? Confirm its status
TychyPolandActive, not recruiting
Medical Network Sp z o o
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Care Access Polska Sp. Z o.o.
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Bodyclinic sp. z o.o. sp.k.
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Vivamed Sp. z o.o.
Coordinator of this site? Confirm its status
WarsawPolandActive, not recruiting
Futuremeds Sp. z o.o.
Coordinator of this site? Confirm its status
WroclawPolandActive, not recruiting
Centrum Medyczne Oporow
Coordinator of this site? Confirm its status
WroclawPolandActive, not recruiting
EMC Instytut Medyczny S.A.
Coordinator of this site? Confirm its status
WrocławPolandActive, not recruiting
Institutul Clinic Fundeni
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Spitalul Universitar de Urgenta Militar Central 'Dr. Carol Davila'
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Spitalul Clinic Colentina Bucuresti
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Centrul Medical Monza S.R.L
Coordinator of this site? Confirm its status
BucharestRomaniaActive, not recruiting
Spitalul Clinic Judetean De Urgenta Cluj
Coordinator of this site? Confirm its status
Cluj-NapocaRomaniaActive, not recruiting
Spital Judetean De Urgenta Satu Mare
Coordinator of this site? Confirm its status
Satu MareRomaniaActive, not recruiting
Centrul De Gastroenterologie Dr. Goldis S.R.L
Coordinator of this site? Confirm its status
TimișoaraRomaniaActive, not recruiting
Asociatia Oncohelp
Coordinator of this site? Confirm its status
TimișoaraRomaniaActive, not recruiting
Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
Clinical Hospital Center "Dr Dragisa Misovic - Dedinje" Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
Clinical Hospital Center "Zvezdara" - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology
Coordinator of this site? Confirm its status
BelgradeSerbiaUnknown status
University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology
Coordinator of this site? Confirm its status
KragujevacSerbiaUnknown status
General Hospital "Djordje Joanovic" Zrenjanin,Internal Medicine Sector - Internal Department
Coordinator of this site? Confirm its status
ZrenjaninSerbiaUnknown status
Changhua Christian Hospital
Coordinator of this site? Confirm its status
ChanghuaTaiwanUnknown status
Kaohsiung Medical University Chung-Ho Memorial Hospital
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Taipei Veterans General Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
MacKay Memorial Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
Chang Gung Memorial Hospital (CGMH)
Coordinator of this site? Confirm its status
Taoyuan CityTaiwanUnknown status
Johns Hopkins Bayview Medical Center
Coordinator of this site? Confirm its status
BaltimoreUnited StatesUnknown status
Dayton Gastroenterology, LLC
Coordinator of this site? Confirm its status
BeavercreekUnited StatesUnknown status
N.Y. Total Medical Care, PC
Coordinator of this site? Confirm its status
BrooklynUnited StatesUnknown status
Om Research LLC
Coordinator of this site? Confirm its status
CamarilloUnited StatesUnknown status
University of Virginia Medical Center
Coordinator of this site? Confirm its status
CharlottesvilleUnited StatesUnknown status
The University of Chicago Medical Center - Duchossois Center for Advanced Medicine
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Gastro Health Research
Coordinator of this site? Confirm its status
CincinnatiUnited StatesUnknown status
Gastro Florida
Coordinator of this site? Confirm its status
ClearwaterUnited StatesUnknown status
Peak Gastroenterology Associates
Coordinator of this site? Confirm its status
Colorado SpringsUnited StatesUnknown status
Gastroenterology Research of San Antonio
Coordinator of this site? Confirm its status
FredericksburgUnited StatesUnknown status
Tandem - Allied Clinical Research, LLC
Coordinator of this site? Confirm its status
FreeholdUnited StatesUnknown status
VVCRD Research
Coordinator of this site? Confirm its status
Garden GroveUnited StatesUnknown status
Amel Med LLC
Coordinator of this site? Confirm its status
GeorgetownUnited StatesUnknown status
NYU Langone Long Island Clinical Research Associates
Coordinator of this site? Confirm its status
Great NeckUnited StatesUnknown status
Carolina Research
Coordinator of this site? Confirm its status
GreenvilleUnited StatesUnknown status
Penn State University Milton S. Hershey Medical Center
Coordinator of this site? Confirm its status
HersheyUnited StatesUnknown status
Best Quality Research, Inc
Coordinator of this site? Confirm its status
HialeahUnited StatesUnknown status
United Research Institute LLC
Coordinator of this site? Confirm its status
HialeahUnited StatesUnknown status
310 Clinical Research
Coordinator of this site? Confirm its status
InglewoodUnited StatesUnknown status
Skyline Gastroenterology of West Tennessee
Coordinator of this site? Confirm its status
JacksonUnited StatesUnknown status
US San Diego Health System
Coordinator of this site? Confirm its status
La JollaUnited StatesUnknown status
Om Research LLC
Coordinator of this site? Confirm its status
LancasterUnited StatesUnknown status
Emeritas Research Group
Coordinator of this site? Confirm its status
Lansdowne Town CenterUnited StatesUnknown status
NexGen Research
Coordinator of this site? Confirm its status
LimaUnited StatesUnknown status
Robley Rex VA Medical Center
Coordinator of this site? Confirm its status
LouisvilleUnited StatesUnknown status
Lenox Hill Hospital
Coordinator of this site? Confirm its status
ManhassetUnited StatesUnknown status
GI Alliance - Mansfield
Coordinator of this site? Confirm its status
MansfieldUnited StatesUnknown status
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Medical Professional Clinical Research Center, Inc
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Blessed Health Care & Research, Inc
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Quality Medical Research
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Vanderbilt Inflammatory Bowel Disease Clinic
Coordinator of this site? Confirm its status
NashvilleUnited StatesUnknown status
Alliance Clinical Research of Tampa, LLC
Coordinator of this site? Confirm its status
New Port RicheyUnited StatesUnknown status
NYU Grossman School of Medicne
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
UCSF Benioff Children's Hospital Oakland
Coordinator of this site? Confirm its status
OaklandUnited StatesUnknown status
Clinical Research of Osceola
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Digestive and Liver Center of Florida, LLC
Coordinator of this site? Confirm its status
OrlandoUnited StatesUnknown status
Gastroenterology Associates of North Mississippi
Coordinator of this site? Confirm its status
OxfordUnited StatesUnknown status
Onyx Clinical Research (Clinic Location)
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Onyx Clinical Research
Coordinator of this site? Confirm its status
PeoriaUnited StatesUnknown status
Gastroenterology Consultants of Southwest Virginia
Coordinator of this site? Confirm its status
RoanokeUnited StatesUnknown status
Mayo Clinic
Coordinator of this site? Confirm its status
RochesterUnited StatesUnknown status
University of California - Davis
Coordinator of this site? Confirm its status
SacramentoUnited StatesUnknown status
Clinical Associates in Research Therapeutics of America, LLC
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Southern Star Research Institute, LLC
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Acclaim Clinical Research
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
SDG Clinical Research, LLC
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
Louisiana Research Center, LLC
Coordinator of this site? Confirm its status
ShreveportUnited StatesUnknown status
EBGS Clinical Research Center
Coordinator of this site? Confirm its status
SnellvilleUnited StatesUnknown status
Piedmont Healthcare
Coordinator of this site? Confirm its status
StatesvilleUnited StatesUnknown status
Digestive Health Specialists (Clinic Visits)
Coordinator of this site? Confirm its status
TupeloUnited StatesUnknown status
Tyler Research Institute, LLC
Coordinator of this site? Confirm its status
TylerUnited StatesUnknown status
St. Charles Clinical Research
Coordinator of this site? Confirm its status
Weldon SpringUnited StatesUnknown status
Gastro Intestinal Research Institute of Northern Ohio, LLC
Coordinator of this site? Confirm its status
WestlakeUnited StatesUnknown status
Encore Medical Research of Weston, LLC
Coordinator of this site? Confirm its status
WestonUnited StatesUnknown status
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center
Coordinator of this site? Confirm its status
WyomingUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.