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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: emvistegrast; Drug: Placebo-to-match emvistegrast

• Study Type: Interventional
• Enrollment (Estimated): 228
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia, 2109
      • Macquarie University
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
      • Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital - Metro South Health
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • The Queen Elizabeth Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Monash Health - Monash Medical Centre
    • Epping, Victoria, Australia, 3076
      • Northern Hospital - Northern Health
    • Fitzroy, Victoria, Australia, 3065
      • Saint Vincent's Hospital Melbourne
    • Footscray, Victoria, Australia, 3011
      • Footscray Hospital - Westerm Health
• Austria
  • Innsbruck, Austria, 6020
    • Medical University Innsbruck, University Hospital for Internal Medicine I
  • Salzburg, Austria, A-5020
    • Regional Hospital Salzburg, University Clinic for Internal Medicine I
  • Vienna, Austria, 1090
    • Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Kortrijk, Belgium, 8500
    • AZ Groeninge
  • Sint-Niklaas, Belgium, 9100
    • Vitaz
• Canada
  • Vaughan, Canada, L4L 4Y7
    • TDDA Specialty Reserach
• Czechia
  • Olomouc, Czechia, 779 00
    • PreventaMed, s.r.o.
  • Slaný, Czechia, 274 01
    • Nemocnice Slany
• France
  • La Tronche, France, 38700
    • Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D
  • Nantes, France, 44000
    • CHU Nantes Gastroenterology department
  • Pierre-Bénite, France, 69495
    • Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology
• Georgia
  • Tbilisi, Georgia, 112
    • ARENSIA Exploratory Medicine
• Germany
  • Dresden, Germany, 01307
    • Universitatsklinikum Carl Gustav Carus an der TU Dresden, Medizinische Klinik und Poliklinik |
  • Halle, Germany, 06108
    • Studiengesellschaft BSF UG
  • Kiel, Germany, 24105
    • University Hospital Schleswig-Holstein, Clinic for Internal Medicine
  • Ulm, Germany, 89081
    • Ulm University Hospital, Centre for Internal Medicine I
• Hong Kong
  • Hong Kong, Hong Kong
    • Princess Margaret Hospital
  • Hong Kong, Hong Kong, 999077
    • Queen Mary Hospital
• Hungary
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem Általános Orvostudományi Kar
  • Budapest, Hungary, 1085
    • Semmelweis Egyetem AOK
  • Budapest, Hungary, 1125
    • Clinexpert Gyogycentrum
  • Békéscsaba, Hungary, 5600
    • Békés Varmegye Kozponti Korhaz, dr Rethy Pal 4. Belgyégyaszat - Gasztroenterologia
• Italy
  • Bologna, Italy, 40138
    • Azienda Ospedaliero-Universitaria Di Bologna IRCCS
  • Cagliari, Italy, 09047
    • Azienda Ospedaliera Brotzu - P.O. San Michele
  • Catanzaro, Italy, 88100
    • AOU "Renato Dulbecco" - Digestive Physiopathology Unit
  • Milan, Italy, 20089
    • San Raffaele Hospital IRCCS
  • Negrar, Italy, 37024
    • IRCCS Ospedale Sacro Cuore Don Calabria
  • Padova, Italy, 35100
    • Azienda Ospedale Università di Padova
  • Palermo, Italy, 90146
    • AOOR Villa Sofia- Cervello
  • Roma, Italy, 00128
    • Campus Biomedico University Hospital Foundation
  • Roma, Italy, 157
    • Ospedale Sandro Pertini
  • San Donato Milanese, Italy, 20097
    • IRCCS Policlinico San Donato
  • San Giovanni Rotondo, Italy, 71013
    • Ospedale Casa Sollievo della Sofferenza IRCCS, Opera di San Pio da Pietrelcina
  • Torino, Italy, 10128
    • Azienda Ospedaliera Ordine Mauriziano di Torino
• Malaysia
  • Johor Bahru, Malaysia, 80100
    • Hospital Sultanah Aminah
  • Kelantan, Malaysia, 16150
    • Hospital Universiti Sains Malaysia
  • Kota Kinabalu, Malaysia, 88586
    • Hospital Queen Elizabeth
  • Kuala Selangor, Malaysia, 43000
    • Hospital Sultan Idris Shah Serdang
  • Kuantan, Malaysia, 25100
    • Hospital Tengku Ampuan Afzan
  • Kuantan, Malaysia, 25200
    • Sultan Ahmad Shah Medical Centre @IIUM
  • Petaling Jaya, Malaysia, 50603
    • University Malaya Medical Centre
• Moldova
  • Chisinau, Moldova, MD-2025
    • PMSI Clinical Republican Hospital "Timofei Molneaga"
• New Zealand
  • Auckland, New Zealand, 0622
    • Pacific Clinical Research Network - Auckland
  • Christchurch, New Zealand, 8011
    • Christchurch Hospital
  • Dunedin, New Zealand, 9012
    • Health New Zealand - Te Whatu Ora Southern, Gastroenterology Department, Dunedin Hospital
• Poland
  • Bydgoszcz, Poland, 85-168
    • Centrum Medyczne "Medis"
  • Katowice, Poland, 40-600
    • NZOZ Holsamed - Oddzial Libero
  • Krakow, Poland, 31-501
    • Krakowskie Centrum Medyczne Sp. z o.o.
  • Krakow, Poland, 30-363
    • Centrum Medyczne Plejady Magdalena Celinska Loewenhoff Michal Zolnowski sp.k.
  • Ksawerów, Poland, 95-054
    • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
  • Lublin, Poland, 20-582
    • Medrise Sp. z o.o.
  • Mazowieckie, Poland, 05-500
    • Centrum Innowacyjnych Terapii Sp. z o.o.
  • Poznan, Poland, 61-441
    • Gabinety Lekarskie Rivermed
  • Poznan, Poland, 60-309
    • EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium
  • Rzeszów, Poland, 35-301
    • Centrum Medyczne Medyk Sp. z 0.0. sp.k.
  • Sopot, Poland, 81-756
    • Endoskopia Sp. z.o.o.
  • Szczecin, Poland, 70-361
    • Sonomed Sp. z 0.0.
  • Szczecin, Poland, 71-434
    • Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.
  • Torun, Poland, 87-100
    • Gastromed Sp. z.o.o.
  • Tychy, Poland, 43-100
    • H-T Centrum Medyczne - Endoterapia
  • Warsaw, Poland, 00-332
    • Bodyclinic sp. z o.o. sp.k.
  • Warsaw, Poland, 00-719
    • Przychodnia care Access Warsawa
  • Warsaw, Poland, 00-728
    • Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus
  • Warsaw, Poland, 03-580
    • Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
  • Wroclaw, Poland, 52416
    • Centrum Medyczne Oporów
  • Wroclaw, Poland, 50-008
    • FutureMeds Wrocław
  • Wroclaw, Poland, 54-144
    • Przychodnia Euromedicare szpital euromedicare
• Romania
  • Bucharest, Romania, 022328
    • Institutul Clinic Fundeni
  • Bucharest, Romania, 020125
    • Spitalul Clinic Colentina
  • Bucharest, Romania, 010825
    • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
  • Bucharest, Romania, 031864
    • Centrul Medical Medicum S.R.L.
  • Bucharest, Romania, 11658
    • Centrul Medical Monza S.R.L
  • Cluj-Napoca, Romania, 3-5
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Cluj-Napoca, Romania, 400132
    • Institutul Regional De Gastroenterologie Hepatologie Prof. Dr. Octavian Fodor Cluj-Napoca
  • Constanța, Romania, 900178
    • Gastromed S.R.L
  • Satu Mare, Romania, 440055
    • Spitalul Județean de Urgență Satu Mare
  • Timișoara, Romania, 300002
    • Asociatia Oncohelp
  • Timișoara, Romania, 300002
    • Centrul De Gastroenterologie Dr. Goldis S.R.L
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center "Bezanijska Kosa", Clinic for Internal Medicine, Gastroenterology and Hepatology Department
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center "Dr Dragisa Misovic - Dedinje" Clinic for Intemal Medicine, Gastroentero logy and Hepatology Department
  • Belgrade, Serbia, 11000
    • Clinical Hospital Center "Zvezdara" - Belgrade, Clinic for Internal Diseases Clinical Department of Gastroenterology and Hepatology
  • Belgrade, Serbia, 112108
    • University Clinical Center of Serbia, Clinic for Gastroenterology and Hepatology
  • Kragujevac, Serbia, 34000
    • University Clinical Center Kragujevac, Clinic for Gastroenterology and Hepatology
  • Zrenjanin, Serbia, 23000
    • General Hospital "Djordje Joanovic" Zrenjanin,Internal Medicine Sector - Internal Department
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital IRB
  • Daegu, South Korea, 41944
    • Kyungpook National University Hospital
  • Daejeon, South Korea, 34943
    • The Catholic University of Korea Daejeon St.Mary's Hospital
  • Guri-si, South Korea, 471-701
    • Kyung Hee University Hospital
  • Jongno-Gu, South Korea, 03181
    • Kangbuk Samsung Hospital
  • Nam-Gu, South Korea, 42415
    • Yeungnam University Hospital
  • Seongdong-gu, South Korea, 4763
    • Hanyang University Seoul Hospital
  • Seoul, South Korea, 05505
    • Asan Medical Center
  • Seoul, South Korea, 6351
    • Samsung Medical Center
  • Seoul, South Korea, 6591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Suwon, South Korea, 16247
    • The Catholic University of Korea
  • Wŏnju, South Korea, 220-701
    • Yonsei University Wonju Severance Christian Hospital
• Spain
  • Ferrol, Spain, 15405
    • Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol
  • Huelva, Spain, 21005
    • Hospital Universitario Juan Ramon Jimenez
  • Santa Cruz de Tenerife, Spain, 38010
    • Hospital Universitario Nuestra Señora de Candelaria
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
• Taiwan
  • Changhua, Taiwan, 505
    • Changhua Christian Hospital
  • Kaohsiung City, Taiwan, 807
    • Kaohsiung Medical University Chung-Ho Memorial Hospital
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taichung, Taiwan, 404327
    • China Medical University Hospital
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital
  • Taipei, Taiwan, 10449
    • Mackay Memorial Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
  • Taoyuan, Taiwan, 333
    • Chang Gung Memorial Hospital (CGMH)
• United Kingdom
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital - North Bristol Trust Clinical Research Centre
  • Bury, United Kingdom, BL9 7TD
    • Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust
  • Cambridge, United Kingdom, CB2 0QQ
    • Cambridge University Hospital NHS Trust, Addenbrookes Hospital
  • Cardiff, United Kingdom, CF159SS
    • Synexus Clinical Research Centre
  • London, United Kingdom, SE5 9RS
    • King's College Hospital
  • North Shields, United Kingdom, NE29 8NH
    • Northumbria Healthcare NHS Foundation Trust, North Tyneside General Hospital
• United States
  • Arizona
    • Peoria, Arizona, United States, 85381
      • Onyx Clinical Research (Clinic Location)
  • California
    • Camarillo, California, United States, 93010
      • Om Research LLC
    • Garden Grove, California, United States, 92845
      • VVCRD Research
    • Inglewood, California, United States, 90301
      • 310 Clinical Research
    • La Jolla, California, United States, 92037
      • US San Diego Health System
    • Lancaster, California, United States, 93534
      • Om Research LLC
    • Oakland, California, United States, 94609
      • UCSF Benioff Children's Hospital Oakland
    • Sacramento, California, United States, 95817
      • University of California, Davis
    • San Diego, California, United States, 92120
      • Acclaim Clinical Research
    • San Diego, California, United States, 92103
      • SDG Clinical Research, LLC
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Peak Gastroenterology Associates
    • Colorado Springs, Colorado, United States, 80921
      • Peak Gastroenterology Associates
  • Florida
    • Clearwater, Florida, United States, 33756
      • Gastro Florida
    • Hialeah, Florida, United States, 33016
      • Best Quality Research, Inc
    • Hialeah, Florida, United States, 33016
      • United Research Institute LLC
    • Miami, Florida, United States, 33136
      • University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
    • Miami, Florida, United States, 33155
      • Medical Professional Clinical Research Center, Inc.
    • Miami, Florida, United States, 33173
      • Blessed Health Care & Research, Inc
    • New Port Richey, Florida, United States, 34653
      • Alliance Clinical Research of Tampa, LLC
    • Orlando, Florida, United States, 32825
      • Digestive and Liver Center of Florida, LLC
    • Orlando, Florida, United States, 34741
      • Clinical Research of Osceola
    • Weston, Florida, United States, 33331
      • Encore Medical Research of Weston, LLC
  • Georgia
    • Snellville, Georgia, United States, 30078
      • EBGS Clinical Research Center
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)
    • Peoria, Illinois, United States, 85381
      • Onyx Clinical Research
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • Robley Rex VA Medical Center
  • Louisiana
    • Shreveport, Louisiana, United States, 71105
      • Louisiana Research Center, LLC
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • Johns Hopkins Bayview Medical Center
  • Michigan
    • Wyoming, Michigan, United States, 49519
      • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Mississippi
    • Oxford, Mississippi, United States, 38655
      • Gastroenterology Associates of North Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Digestive Health Specialists (Clinic Visits)
  • Missouri
    • Weldon Spring, Missouri, United States, 63304
      • St Charles Clinical Research
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • Tandem - Allied Clinical Research, LLC
  • New York
    • Brooklyn, New York, United States, 11215
      • N.Y. Total Medical Care, PC
    • Great Neck, New York, United States, 11021
      • NYU Langone Long Island Clinical Research Associates
    • Manhasset, New York, United States, 11030
      • Lenox Hill Hospital
    • New York, New York, United States, 10016
      • NYU Grossman School of Medicne
  • North Carolina
    • Greenville, North Carolina, United States, 27834
      • Carolina Research
    • Statesville, North Carolina, United States, 28625
      • Piedmont Healthcare
  • Ohio
    • Beavercreek, Ohio, United States, 45440
      • Dayton Gastroenterology, LLC
    • Cincinnati, Ohio, United States, 45219
      • Gastro Health Research
    • Lima, Ohio, United States, 45801
      • Nexgen Research
    • Westlake, Ohio, United States, 44145
      • Gastro Intestinal Research Institute of Northern Ohio, LLC
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State University Milton S. Hershey Medical Center
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Skyline gastroenterology of west Tennessee
    • Nashville, Tennessee, United States, 37211
      • Quality Medical Research
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt Inflammatory Bowel Disease Clinic
  • Texas
    • Fredericksburg, Texas, United States, 78624
      • Gastroenterology Research of San Antonio
    • Georgetown, Texas, United States, 78628
      • Amel Med LLC
    • Mansfield, Texas, United States, 76063
      • GI Alliance - Mansfield
    • San Antonio, Texas, United States, 78212
      • Clinical Associates in Research Therapeutics of America, LLC
    • San Antonio, Texas, United States, 78229
      • Southern Star Research Institute, LLC.
    • Tyler, Texas, United States, 75701
      • Tyler Research Institute, LLC.
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Lansdowne Town Center, Virginia, United States, 20176
      • Emeritas Research Group
    • Roanoke, Virginia, United States, 24014
      • Gastroenterology Consultants of Southwest Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• Individuals have Ulcerative Colitis (UC) with symptoms of at least 90 days duration before randomization, with the diagnosis confirmed by endoscopy and histology at any time prior to randomization. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents.
• Individuals have UC with minimum disease extent of 15 cm from the anal verge.
• Individuals have moderately to severely active UC as determined by endoscopy occurring during screening with a total modified Mayo Clinic Score (mMCS) of 5 to 9 points, including a centrally read endoscopic subscore of at least 2.
• Individuals have an inadequate response or loss of response or are intolerant to at least 1 of the following UC treatments: corticosteroids, immunomodulators, or advanced therapy.
• Individuals have an inadequate response or loss of response or are intolerant to < 3 AT mechanisms of action for UC (use of 2 or more AT with the same mechanism of action, eg, 2 TNF-α inhibitors, counts as 1 mechanism of action)

Key Exclusion Criteria:

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

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A, Part B, Part C: Emvistegrast Dose A; Participants 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).	Drug: emvistegrast; Administered orally; Other Names: GS-1427
Experimental: Part A, Part B, Part C: Emvistegrast Dose B; Participants 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).	Drug: emvistegrast; Administered orally; Other Names: GS-1427
Experimental: Part A, Part B, Part C: Emvistegrast Dose C; Participants 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).	Drug: emvistegrast; Administered orally; Other Names: GS-1427
Experimental: Part A, Placebo; Part B, Part C: Emvistegrast; Participants 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).	Drug: emvistegrast; Administered orally; Other Names: GS-1427; Drug: Placebo-to-match emvistegrast; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 12
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.	Week 52
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	Week 12
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.	Week 12
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).	Week 12
Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.		First dose date up to 116 weeks plus 28 days
Incidence of Treatment-emergent Lab Abnormalities		First dose date up to 116 weeks plus 28 days
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.	Week 52

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Investigators: Study Director: Gilead Study Director, Gilead Sciences

Publications and helpful links

Helpful Links

• Gilead Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2024
• Primary Completion (Actual): March 4, 2026
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 16, 2024
• First Submitted That Met QC Criteria: March 1, 2024
• First Posted (Actual): March 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Colitis; Colitis, Ulcerative; Dermatologic Agents; Ustekinumab
• Other Study ID Numbers: GS-US-409-5704; 2023-508304-38 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No