AzTrials
AzTrials

Ulcerative ColitisPhase 2SWIFTNCT06290934

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

A Phase 2 study testing emvistegrast in people with Ulcerative Colitis, run by Gilead Sciences at 181 sites in 22 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
emvistegrast
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
228 participants
Where
181 sitesin 22 countries
Study dates
27 Mar 2024to Apr 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

181 sites in 22 countries.

181 sites in 22 countries

United States57 sites

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

  • Dayton Gastroenterology, LLC

    Beavercreek, Ohio, 45440

  • N.Y. Total Medical Care, PC

    Brooklyn, New York, 11215

  • Om Research LLC

    Camarillo, California, 93010

  • University of Virginia Medical Center

    Charlottesville, Virginia, 22908

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

    Chicago, Illinois, 60637

  • Gastro Health Research

    Cincinnati, Ohio, 45219

  • Gastro Florida

    Clearwater, Florida, 33756

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80907

  • Peak Gastroenterology Associates

    Colorado Springs, Colorado, 80921

  • Gastroenterology Research of San Antonio

    Fredericksburg, Texas, 78624

  • Tandem - Allied Clinical Research, LLC

    Freehold, New Jersey, 07728

  • VVCRD Research

    Garden Grove, California, 92845

  • Amel Med Llc

    Georgetown, Texas, 78628

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Carolina Research

    Greenville, North Carolina, 27834

  • Penn State University Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Best Quality Research, Inc

    Hialeah, Florida, 33016

  • United Research Institute LLC

    Hialeah, Florida, 33016

  • 310 Clinical Research

    Inglewood, California, 90301

  • Skyline gastroenterology of west Tennessee

    Jackson, Tennessee, 38301

  • US San Diego Health System

    La Jolla, California, 92037

  • Om Research LLC

    Lancaster, California, 93534

  • Emeritas Research Group

    Lansdowne Town Center, Virginia, 20176

  • NexGen Research

    Lima, Ohio, 45801

  • Robley Rex VA Medical Center

    Louisville, Kentucky, 40206

  • Lenox Hill Hospital

    Manhasset, New York, 11030

  • GI Alliance - Mansfield

    Mansfield, Texas, 76063

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

    Miami, Florida, 33136

  • Medical Professional Clinical Research Center, Inc.

    Miami, Florida, 33155

  • Blessed Health Care & Research, Inc

    Miami, Florida, 33173

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Vanderbilt Inflammatory Bowel Disease Clinic

    Nashville, Tennessee, 37232

  • Alliance Clinical Research of Tampa, LLC

    New Port Richey, Florida, 34653

  • NYU Grossman School of Medicne

    New York, New York, 10016

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California, 94609

  • Digestive and Liver Center of Florida, LLC

    Orlando, Florida, 32825

  • Clinical Research of Osceola

    Orlando, Florida, 34741

  • Gastroenterology Associates of North Mississippi

    Oxford, Mississippi, 38655

  • Onyx Clinical Research (Clinic Location)

    Peoria, Arizona, 85381

  • Onyx Clinical Research

    Peoria, Illinois, 85381

  • Gastroenterology Consultants of Southwest Virginia

    Roanoke, Virginia, 24014

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University Of California, Davis

    Sacramento, California, 95817

  • Clinical Associates in Research Therapeutics of America, LLC

    San Antonio, Texas, 78212

  • Southern Star Research Institute, LLC.

    San Antonio, Texas, 78229

  • SDG Clinical Research, LLC

    San Diego, California, 92103

  • Acclaim Clinical Research

    San Diego, California, 92120

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • EBGS Clinical Research Center

    Snellville, Georgia, 30078

  • Piedmont Healthcare

    Statesville, North Carolina, 28625

  • Digestive Health Specialists (Clinic Visits)

    Tupelo, Mississippi, 38801

  • Tyler Research Institute, LLC.

    Tyler, Texas, 75701

  • St Charles Clinical Research

    Weldon Spring, Missouri, 63304

  • Gastro Intestinal Research Institute of Northern Ohio, LLC

    Westlake, Ohio, 44145

  • Encore Medical Research of Weston, LLC

    Weston, Florida, 33331

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

    Wyoming, Michigan, 49519

Other trials in United States

Poland22 sites

  • Centrum Medyczne "Medis"

    Bydgoszcz, 85-168

  • NZOZ Holsamed - Oddzial Libero

    Katowice, 40-600

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

    Krakow, 30-363

  • Krakowskie Centrum Medyczne Sp. z o.o.

    Krakow, 31-501

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

    Ksawerów, 95-054

  • Medrise Sp. z o.o.

    Lublin, 20-582

  • Centrum Innowacyjnych Terapii Sp. z o.o.

    Mazowieckie, 05-500

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

    Poznan, 60-309

  • Gabinety Lekarskie RIVERMED

    Poznan, 61-441

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

    Rzeszów, 35-301

  • Endoskopia Sp. z.o.o.

    Sopot, 81-756

  • Sonomed Sp. z 0.0.

    Szczecin, 70-361

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

    Szczecin, 71-434

  • Gastromed Sp. z.o.o.

    Torun, 87-100

  • H-T Centrum Medyczne - Endoterapia

    Tychy, 43-100

  • Bodyclinic Sp. z o.o. sp.k.

    Warsaw, 00-332

  • Przychodnia care Access Warsawa

    Warsaw, 00-719

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

    Warsaw, 00-728

  • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz

    Warsaw, 03-580

  • FutureMeds Wrocław

    Wroclaw, 50-008

  • Centrum Medyczne Oporow

    Wroclaw, 52416

  • Przychodnia Euromedicare szpital euromedicare

    Wroclaw, 54-144

Other trials in Poland

Italy12 sites

  • Azienda Ospedaliero-Universitaria Di Bologna IRCCS

    Bologna, 40138

  • Azienda Ospedaliera Brotzu - P.O. San Michele

    Cagliari, 09047

  • AOU "Renato Dulbecco" - Digestive Physiopathology Unit

    Catanzaro, 88100

  • San Raffaele Hospital IRCCS

    Milan, 20089

  • IRCCS Ospedale Sacro Cuore Don Calabria

    Negrar, 37024

  • Azienda Ospedale Universita di Padova

    Padova, 35100

  • AOOR Villa Sofia- Cervello

    Palermo, 90146

  • Campus Biomedico University Hospital Foundation

    Roma, 00128

  • Ospedale Sandro Pertini

    Roma, 157

  • IRCCS Policlinico San Donato

    San Donato Milanese, 20097

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

    San Giovanni Rotondo, 71013

  • Azienda Ospedaliera Ordine Mauriziano di Torino

    Torino, 10128

Other trials in Italy

South Korea12 sites

  • Inje University Haeundae Paik Hospital IRB

    Busan, 48108

  • Kyungpook National University Hospital

    Daegu, 41944

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

    Daejeon, 34943

  • Kyung Hee University Hospital

    Guri-si, 471-701

  • Kangbuk Samsung Hospital

    Jongno-Gu, 03181

  • Yeungnam University Hospital

    Nam-Gu, 42415

  • Hanyang University Seoul Hospital

    Seongdong-gu, 4763

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 6351

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

    Seoul, 6591

  • The Catholic University of Korea

    Suwon, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Romania11 sites

  • Spitalul Universitar De Urgenta Militar Central Dr. Carol Davila

    Bucharest, 010825

  • Spitalul Clinic Colentina

    Bucharest, 020125

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Centrul Medical Medicum S.R.L.

    Bucharest, 031864

  • Centrul Medical Monza S.R.L

    Bucharest, 11658

  • Spitalul Clinic Judetean De Urgenta Cluj-Napoca

    Cluj-Napoca, 3-5

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

    Cluj-Napoca, 400132

  • Gastromed S.R.L

    Constanța, 900178

  • Spitalul Judetean de Urgenta Satu Mare

    Satu Mare, 440055

  • Asociatia Oncohelp

    Timișoara, 300002

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

    Timișoara, 300002

Other trials in Romania

Australia8 sites

  • Monash Health - Monash Medical Centre

    Clayton, Victoria, 3168

  • Northern Hospital - Northern Health

    Epping, Victoria, 3076

  • Saint Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Footscray Hospital - Westerm Health

    Footscray, Victoria, 3011

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

    South Brisbane, Queensland, 4101

  • Macquarie University

    Sydney, New South Wales, 2109

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

  • Princess Alexandra Hospital - Metro South Health

    Woolloongabba, Queensland, 4102

Other trials in Australia

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 505

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • China Medical University Hospital

    Taichung, 404327

  • Taichung Veterans General Hospital

    Taichung, 40705

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

    Taipei, 100

  • MacKay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Chang Gung Memorial Hospital (CGMH)

    Taoyuan City, 333

Other trials in Taiwan

Malaysia7 sites

  • Hospital Sultanah Aminah

    Johor Bahru, 80100

  • Hospital Universiti Sains Malaysia

    Kelantan, 16150

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

  • Hospital Sultan Idris Shah Serdang

    Kuala Selangor, 43000

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

  • Sultan Ahmad Shah Medical Centre @IIUM

    Kuantan, 25200

  • University Malaya Medical Centre

    Petaling Jaya, 50603

Other trials in Malaysia

Serbia6 sites

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

    Belgrade, 11000

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

    Belgrade, 11000

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

    Belgrade, 11000

  • University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology

    Belgrade, 112108

  • University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology

    Kragujevac, 34000

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

    Zrenjanin, 23000

Other trials in Serbia

United Kingdom6 sites

  • Southmead Hospital - North Bristol Trust Clinical Research Centre

    Bristol, BS10 5NB

  • Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust

    Bury, BL9 7TD

  • Cambridge University Hospital NHS Trust, Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • Synexus Clinical Research Centre

    Cardiff, CF159SS

  • King's College Hospital

    London, SE5 9RS

  • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital

    North Shields, NE29 8NH

Other trials in United Kingdom

Spain5 sites

  • Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol

    Ferrol, 15405

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario Nuestra Senora de Candelaria

    Santa Cruz de Tenerife, 38010

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Germany4 sites

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

    Dresden, 01307

  • Studiengesellschaft BSF UG

    Halle, 06108

  • University Hospital Schleswig-Holstein, Clinic for Internal Medicine

    Kiel, 24105

  • Ulm University Hospital, Centre for Internal Medicine I

    Ulm, 89081

Other trials in Germany

Hungary4 sites

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

    Békéscsaba, 5600

  • Semmelweis Egyetem AOK

    Budapest, 1085

  • Semmelweis Egyetem Általanos Orvostudományi Kar

    Budapest, 1085

  • Clinexpert Gyógycentrum

    Budapest, 1125

Other trials in Hungary

Austria3 sites

  • Medical University Innsbruck, University Hospital for Internal Medicine I

    Innsbruck, 6020

  • Regional Hospital Salzburg, University Clinic for Internal Medicine I

    Salzburg, A-5020

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

    Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ Groeninge

    Kortrijk, 8500

  • Vitaz

    Sint-Niklaas, 9100

Other trials in Belgium

France3 sites

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

    La Tronche, 38700

  • CHU Nantes Gastroenterology department

    Nantes, 44000

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

    Pierre-Bénite, 69495

Other trials in France

New Zealand3 sites

  • Pacific Clinical Research Network - Auckland

    Auckland, 0622

  • Christchurch Hospital

    Christchurch, 8011

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

    Dunedin, 9012

Other trials in New Zealand

Czechia2 sites

  • PreventaMed, s.r.o.

    Olomouc, 779 00

  • Nemocnice Slany

    Slaný, 274 01

Other trials in Czechia

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong, 999077

  • Princess Margaret Hospital

    Hong Kong

Other trials in Hong Kong

Canada1 site

  • TDDA Specialty Reserach

    Vaughan, L4L 4Y7

Other trials in Canada

Georgia1 site

  • ARENSIA Exploratory Medicine

    Tbilisi, 112

Other trials in Georgia

Moldova1 site

  • PMSI Clinical Republican Hospital "Timofei Molneaga"

    Chisinau, MD-2025

Other trials in Moldova

About this study

Official title: 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)

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.

Being tested
emvistegrast, Placebo-to-match emvistegrast
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • emvistegrastDrug

    Also called GS-1427

    Administered orally

  • Placebo-to-match emvistegrastDrug

    Administered orally

Study groups in NCT06290934
Study groupRoleWhat they receive
Part A, Part B, Part C: Emvistegrast Dose AExperimentalParticipants will receive emvistegrast 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 emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116).
Receives: Drug: emvistegrast
Part A, Part B, Part C: Emvistegrast Dose BExperimentalParticipants will receive emvistegrast 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 emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: Blinded treatment extension for an additional 64 weeks (through Week 116).
Receives: Drug: emvistegrast
Part A, Part B, Part C: Emvistegrast Dose CExperimentalParticipants will receive emvistegrast 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 emvistegrast through Week 52 (Part B). Participants who complete Part B of the study will continue onto Part C: blinded treatment extension for an additional 64 weeks (through Week 116).
Receives: Drug: emvistegrast
Part A, Placebo; Part B, Part C: EmvistegrastExperimentalParticipants will receive Placebo to match emvistegrast 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 emvistegrast 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 64 weeks (through Week 116).
Receives: Drug: emvistegrast; Drug: Placebo-to-match emvistegrast

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of Participants Achieving Clinical Response at Week 12

    Clinical response is defined as a decrease from baseline in the modified Mayo Clinic Score (mMCS) of ≥ 2 points and at least a 30% reduction from baseline, and a decrease in rectal bleeding subscore of ≥ 1 from baseline or an absolute rectal bleeding subscore of 0 or 1. The mMCS is a scoring system for assessment of Ulcerative Colitis (UC) activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

    Measured: Week 12

Secondary outcomes (8)

  1. Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.

    Measured: First dose date up to 116 weeks plus 28 days

  2. Incidence of Treatment-emergent Lab Abnormalities

    Measured: First dose date up to 116 weeks plus 28 days

  3. Proportion of Participants Achieving Clinical Remission at Week 12

    Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability).The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

    Measured: Week 12

  4. Proportion of Participants Achieving Clinical Remission at Week 52

    Clinical remission is defined as a mMCS of ≤ 2, including a stool frequency subscore (SFS) ≤ 1 and not greater than baseline, rectal bleeding subscore of 0, and centrally read endoscopic subscore ≤ 1 (score of 1 modified to exclude friability). The mMCS is a scoring system for assessment of UC activity and is composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration)), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), and stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 or more stools more than normal). Total score for mMCS ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.

    Measured: Week 52

  5. Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12

    Histologic-endoscopic mucosal improvement is a composite endpoint that uses different units of measure for histologic and endoscopic activities.Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils \& eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Histologic-endoscopic mucosal improvement is defined as achieving both Geboes score ≤ 3.1 and endoscopic subscore ≤ 1

    Measured: Week 12

  6. Proportion of Participants Achieving Mucosal Healing at Week 12

    Mucosal healing is a composite endpoint that uses different units of measure for histologic and endoscopic activities. Histologic activity is measured by the Geboes score with 6 grades:0,structural change(sub-grade:0.0-0.3);1,chronic inflammatory infiltrate(sub-grade:1.0-1.3);2,lamina propria neutrophils \& eosinophils(sub-grade:2A.0-2B.3);3,neutrophils in epithelium(sub-grade:3.0-3.3);4,crypt destruction(sub-grade:4.0-4.3); and 5,erosion or ulceration(sub-grade:5.0-5.4);final score range 0.0-5.4;higher scores indicate more severe inflammation.Endoscopic activity is measured by the Mayo Clinic Score Endoscopic subscores(range 0-3):0,normal or inactive disease;1,mild disease(erythema,decreased vascular pattern);2,moderate disease(marked erythema,lack of vascular pattern,friability,erosions), and 3,severe disease(spontaneous bleeding,ulceration).Mucosal healing is defined as achieving both Geboes score ≤ 2B.1 and endoscopic subscore ≤ 1.

    Measured: Week 12

  7. Proportion of Participants Achieving Endoscopic Improvement at Week 12

    Endoscopic improvement is defined as an endoscopic subscore of ≤ 1. Endoscopic subscore is a part of the modified Mayo Clinic Score which is a scoring system for assessment of UC activity. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern), 2 = moderate disease (marked erythema, lack of vascular pattern, friability, erosions), and 3 = severe disease (spontaneous bleeding, ulceration).

    Measured: Week 12

  8. To Assess the Efficacy of Emvistegrast in Achieving Partial Modified Mayo Clinic Score (mMCS) remission at Week 52

    Partial mMCS remission is defined as a SFS ≤ 1 and rectal bleeding subscore of 0.

    Measured: Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2024
  2. Study start27 Mar 2024
  3. Primary completion4 Mar 2026
  4. Study completionApr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
228 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06290934
Sponsor's protocol ID
GS-US-409-5704
Other IDs
2023-508304-38, 2023
Acronym
SWIFT
Status last verified
Apr 2026
First submitted
16 Feb 2024
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing emvistegrast in people with Ulcerative Colitis, run by Gilead Sciences at 181 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in United States, Poland, Italy, South Korea, Romania and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Participants Achieving Clinical Response at Week 12 (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06290934.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in