Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis (PALEKONA)

A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo.

The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Study Overview

• Status: Recruiting
• Conditions: Ulcerative Colitis
• Intervention / Treatment: Drug: Placebo; Drug: Tilpisertib Fosmecarbil

• Study Type: Interventional
• Enrollment (Estimated): 176
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Gilead Clinical Study Information Center; Phone Number: 1-833-445-3230 (GILEAD-0); Email: GileadClinicalTrials@gilead.com

Study Locations

• Australia
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Recruiting
      • Sunshine Coast University Hospital
    • South Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Mater Adult Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Recruiting
      • Princess Alexandra Hospital
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Royal Adelaide Hospital
    • Woodville, South Australia, Australia, 5011
      • Recruiting
      • Queen Elizabeth Hospital
  • Victoria
    • Clayton, Victoria, Australia, 3168
      • Withdrawn
      • Monash Medical Centre
    • Epping, Victoria, Australia, 3076
      • Recruiting
      • Northern Health
    • Footscray, Victoria, Australia, 3011
      • Recruiting
      • Footscray Hospital
  • Western Australia
    • Murdoch, Western Australia, Australia, 6150
      • Recruiting
      • Fiona Stanley Hospital
• Austria
  • Innsbruck, Austria, 6020
    • Recruiting
    • Medical University of Innsbruck
  • Salzburg, Austria, 5020
    • Not yet recruiting
    • University of Salzburg, Universitätsklinik für Innere Medizin III
  • Sankt Pölten, Austria, 3100
    • Recruiting
    • Universitätsklinikum St. Pölten
  • Vienna, Austria, 1090
    • Recruiting
    • Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • Universitaire Ziekenhuis Leuven
• Canada
  • London, Canada, N6A 5A5
    • Recruiting
    • London Health Sciences Centre-University Hospital
  • Toronto, Canada, MSG 1X5
    • Recruiting
    • Mount Sinai Hospital
  • Toronto, Canada, M2K 2W2
    • Withdrawn
    • Physician's Clinical Research, Inc. (PCRI)
  • Vaughan, Canada, L4L 4Y7
    • Recruiting
    • TDDA Speciality Research
• France
  • Grenoble, France, 38043
    • Recruiting
    • Centre Hospitalier Universitaire Grenoble
  • Little Cedex, France, 59037
    • Recruiting
    • Hopital Claude Huriez
  • Montpellier, France, 34295
    • Recruiting
    • Hopital Saint Eloi
  • Nantes, France, 44000
    • Recruiting
    • Centre Hospitalier Universitaire de Nantes
  • Neuilly-sur-Seine, France, 92200
    • Recruiting
    • Institut des MICI
  • Saint-Etienne, France, 42055
    • Recruiting
    • CHU de Saint Etienne - Hopital Nord
  • Toulouse, France, 31059
    • Recruiting
    • Hôpital Rangueil
  • Vandœuvre-lès-Nancy, France, 54500
    • Recruiting
    • CHRU Nancy
• Germany
  • Berlin, Germany, 13353
    • Not yet recruiting
    • Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
  • Hanover, Germany, 30625
    • Not yet recruiting
    • Medizinische Hochschule Hannover
  • Kiel, Germany, 24105
    • Recruiting
    • Universitätsklinikum Schleswig-Holstein
  • Liepzig, Germany, 4103
    • Recruiting
    • Eugastro GmbH
  • Ulm, Germany, 89081
    • Not yet recruiting
    • Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
• Hungary
  • Beri Balogh, Hungary, 7100
    • Recruiting
    • Tolna Megye Balassa Janos Korhaz
  • Budapest, Hungary, 1033
    • Recruiting
    • Szent Janos Korhaz es Eszak-Budai Egyesitett Korhazak
• Italy
  • Catanzaro, Italy, 88100
    • Recruiting
    • AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
  • Milan, Italy, 20089
    • Recruiting
    • IRCCS Istituto Clinico Humanitas
  • Roma, Italy, 00152
    • Recruiting
    • Azienda Ospedaliera San Camillo Forlanini
  • Rozzano, Italy, 20089
    • Recruiting
    • Istituto Clinico Humanitas
  • Udine, Italy, 33100
    • Withdrawn
    • Azienda Sanitaria Universitaria Friuli Centrale
• Japan
  • Hyōgo, Japan, 663-8501
    • Recruiting
    • Hyogo Medical University Hospital
  • Jonan-ku, Japan, 814-0180
    • Recruiting
    • Fukuoka University Hospital
  • Minatoku, Japan, 105-8471
    • Recruiting
    • The Jikei University Hospital
  • Minatoku, Japan, 108-8642
    • Recruiting
    • Kitasato University Kitasato Institute Hospital
  • Mitaka-shi, Japan, 181-8611
    • Recruiting
    • Kyorin University Hospital
  • Nagasaki, Japan, 852-8501
    • Recruiting
    • Nagasaki University Hospital
  • Sagaken, Japan, 849-8501
    • Recruiting
    • Saga University Hospital
  • Sagamihara, Japan, 252-0375
    • Recruiting
    • Kitasato University Hospital
  • Sapporo, Japan, 060-8543
    • Recruiting
    • Sapporo Medical University Hospital
  • Tokyo, Japan, 104-0061
    • Recruiting
    • Ginza central clinic
  • Toukiyouto, Japan, 113-8519
    • Recruiting
    • Institute of Science Tokyo Hospital
  • Ōita, Japan, 870-0823
    • Recruiting
    • Ishida Clinic of IBD and Gastroenterology
• Poland
  • Katowice, Poland, 40-659
    • Withdrawn
    • Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
  • Krakow, Poland, 31-009
    • Recruiting
    • Gabinet Endoskopii Przewodu Pokarmowego
  • Lublin, Poland, 20-852
    • Not yet recruiting
    • Medrise Sp. z o.o. Centrum Badan Klinicznych
  • Poznan, Poland, 60-425
    • Not yet recruiting
    • Solumed Centrum Medyczne
  • Rzeszów, Poland, 35-210
    • Recruiting
    • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
  • Sopot, Poland, 81-756
    • Recruiting
    • Specjalistyczna Praktyka Lekarska Leszek Bryniarski
  • Torun, Poland, 87-100
    • Recruiting
    • GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
  • Warsaw, Poland, 00-728
    • Recruiting
    • Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
  • Warsaw, Poland, 03-580
    • Withdrawn
    • NZOZ Vivamed
  • Warsaw, Poland, 03-712
    • Recruiting
    • Specjalistyczne Gabinety Lekarskie Body Clinic
  • Wroclaw, Poland, 52-416
    • Recruiting
    • Centrum Medyczne Oporow
• South Korea
  • Busan, South Korea, 48108
    • Recruiting
    • Inje University
  • Daegu, South Korea, 42415
    • Recruiting
    • Yeungnam University Hospital
  • Junggu, South Korea, 41944
    • Recruiting
    • Kyungpook National University Hospital
  • Seoul, South Korea, 06351
    • Recruiting
    • Samsung Medical Center
  • Seoul, South Korea, 03181
    • Recruiting
    • Kangbuk Samsung Hospital
  • Seoul, South Korea, 02447
    • Recruiting
    • Kyung Hee University Medical Center
  • Seoul, South Korea, 04763
    • Recruiting
    • Hanyang University Hospital
  • Wŏnju, South Korea, 26426
    • Recruiting
    • WonJu Severance Christian Hospital
  • VIC
    • Seodaemun-Gu, VIC, South Korea, 3772
      • Recruiting
      • Yonsei University Severance Hospital
• Switzerland
  • Bern, Switzerland, 3012
    • Recruiting
    • Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
• United Kingdom
  • Bury, United Kingdom, BL9 7TD
    • Recruiting
    • Fairfield General Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Recruiting
    • Cambridge University Hospitals NHS Foundation Trust
  • London, United Kingdom, E1 2AJ
    • Recruiting
    • Barts Health NHS Trust
  • Norwich, United Kingdom, NR4 7UZ
    • Recruiting
    • Norfolk and Norwich University Hospital NHS Foundation Trust
  • Southampton, United Kingdom, SO16 6YD
    • Recruiting
    • University Hospital Southampton NHS Foundation Trust
• United States
  • Arizona
    • Sun City, Arizona, United States, 85351
      • Recruiting
      • GI Alliance
  • California
    • Chula Vista, California, United States, 91910
      • Recruiting
      • GastroSb Weight Loss Clinic
    • Coronado, California, United States, 92118
      • Recruiting
      • Southern California Research Centers
    • Garden Grove, California, United States, 92845
      • Recruiting
      • VVCRD Research
    • La Jolla, California, United States, 92037
      • Recruiting
      • UC San Diego Health System
    • Lancaster, California, United States, 93534
      • Recruiting
      • Gastro Care Institute
    • Lancaster, California, United States, 93534
      • Recruiting
      • Om Research LLC
    • Murrieta, California, United States, 92563
      • Withdrawn
      • United Medical Doctors
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis
    • San Francisco, California, United States, 94115
      • Recruiting
      • University of California San Francisco
    • Valencia, California, United States, 91355
      • Withdrawn
      • Amicis Research Center
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Recruiting
      • Luna Research
    • Gainesville, Florida, United States, 32610
      • Recruiting
      • University of Florida
    • Hollywood, Florida, United States, 33021
      • Recruiting
      • The Medici Medical Research
    • Hollywood, Florida, United States, 33024
      • Withdrawn
      • Encore Medical Research, LLC
    • Kissimmee, Florida, United States, 34741
      • Recruiting
      • Clinical Research of Osceola
    • Largo, Florida, United States, 33771
      • Recruiting
      • Florida Research Institute
    • Miami, Florida, United States, 33135
      • Withdrawn
      • Wellness Research Center
    • Miami, Florida, United States, 33176
      • Withdrawn
      • IMIC Inc
    • Miami, Florida, United States, 33176
      • Withdrawn
      • Reserka LLC
    • Naples, Florida, United States, 34102
      • Recruiting
      • GI Pros Research
    • Orlando, Florida, United States, 32825
      • Recruiting
      • Digestive and Liver Center of Florida, LLC
    • Orlando, Florida, United States, 32807
      • Recruiting
      • Clinical One Research
    • Port Orange, Florida, United States, 32127
      • Recruiting
      • Advanced Medical Research Center
    • Wellington, Florida, United States, 33414
      • Withdrawn
      • Gastroenterology Associates of Florida - GI Alliance
  • Georgia
    • Decatur, Georgia, United States, 30033
      • Withdrawn
      • Atlanta Center For Gastroenterology P.C.
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Recruiting
      • Corewell Health
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
  • Mississippi
    • Oxford, Mississippi, United States, 38655
      • Recruiting
      • Gastroenterology Associates of North Mississippi
    • Tupelo, Mississippi, United States, 38801
      • Recruiting
      • Digestive Health Specialists
  • Missouri
    • St Louis, Missouri, United States, 63141
      • Recruiting
      • St. Charles Clinical Research
  • New York
    • Brooklyn, New York, United States, 11215
      • Active, not recruiting
      • Ellipsis Research Group
    • Great Neck, New York, United States, 11021
      • Recruiting
      • NYU Langone Long Island Clinical Research Associates
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Gastroenterology & Hepatology Specialists Inc
    • Cincinnati, Ohio, United States, 45249
      • Withdrawn
      • Ohio Gastroenterology & Liver Institute
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Centre
    • Dayton, Ohio, United States, 45145
      • Recruiting
      • Dayton Gastroenterology, LLC
    • Mentor, Ohio, United States, 44060
      • Recruiting
      • Great Lakes Gastroenterology Research, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73134
      • Withdrawn
      • Hightower Clinical
  • Tennessee
    • Jackson, Tennessee, United States, 38301
      • Not yet recruiting
      • Skyline gastroenterology of west Tennessee
  • Texas
    • Boerne, Texas, United States, 78006
      • Recruiting
      • Gastroenterology Research of Hill Country
    • El Paso, Texas, United States, 79936
      • Withdrawn
      • Gastroenterology Research of America
    • Garland, Texas, United States, 75044
      • Withdrawn
      • DHAT Research Institute
    • Houston, Texas, United States, 77074
      • Withdrawn
      • Southwest Clinical Trials
    • Lubbock, Texas, United States, 79410
      • Recruiting
      • GI Alliance
    • Mansfield, Texas, United States, 76063
      • Recruiting
      • GI Associates and Endoscopy Center - GI Alliance
    • San Antonio, Texas, United States, 78212
      • Recruiting
      • Clinical Associates in Research Therapeutics of America
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • Gastroenterology Research of San Antonio
    • Tyler, Texas, United States, 75701
      • Recruiting
      • Tyler Research Institute, LLC
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • Recruiting
      • Gastroenterology Associates of Tidewater
    • Lansdowne Town Center, Virginia, United States, 20176
      • Recruiting
      • Emeritas Group Research
    • Roanoke, Virginia, United States, 24014
      • Recruiting
      • Gastroenterology Consultants of Southwest Virginia
  • Washington
    • Seattle, Washington, United States, 98122
      • Withdrawn
      • Swedish Medical Center

Participation Criteria

Eligibility Criteria

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

Description

Key Inclusion Criteria:

• Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit.
• Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.
• Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).
• Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.
• A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.

Key Exclusion Criteria:

• Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
• Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
• Requirement for ongoing therapy with or prior use of any prohibited medications.
• Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks.

of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.

• History of opportunistic infection.
• Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

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: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tilpisertib Fosmecarbil Dose A; Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.	Drug: Tilpisertib Fosmecarbil; Tablets administered orally; Other Names: GS-5290
Experimental: Tilpisertib Fosmecarbil Dose B; Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.	Drug: Tilpisertib Fosmecarbil; Tablets administered orally; Other Names: GS-5290
Experimental: Tilpisertib Fosmecarbil Dose C; Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.	Drug: Tilpisertib Fosmecarbil; Tablets administered orally; Other Names: GS-5290
Placebo Comparator: Tilpisertib Fosmecarbil Placebo; Blinded Treatment Phase: Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12. • Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52. Non-responder Treatment Phase: • Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug.	Drug: Placebo; Tablets administered orally; Drug: Tilpisertib Fosmecarbil; Tablets administered orally; Other Names: GS-5290

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12	Clinical Response is defined as a decrease from baseline of ≥ 2 points and at least 30% in 3 components of the modified Mayo Clinic Score, Stool Frequency, Rectal Bleeding, and Endoscopic Findings, in addition to a ≥ 1 point decrease from baseline in the Rectal Bleeding subscore or Rectal Bleeding subscore of ≤ 1. The modified Mayo Clinic Score 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 modified Mayo Clinic Score 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
Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)		First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities		First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12	Clinical Remission is defined as a Stool Frequency subscore ≤ 1 and not greater than baseline, Rectal Bleeding subscore of 0, and Endoscopic Findings subscore ≤ 1 at Week 12. The modified Mayo Clinic Score 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), 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 modified Mayo Clinic Score ranges from 0 to 9 (sum of all subscores), with higher scores indicating higher disease activity.	Week 12
Proportion of Participants Achieving Endoscopic Response at Week 12	Endoscopic Response is defined as an Endoscopic Findings subscore ≤ 1 at Week 12. 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). Higher scores indicate higher disease activity.	Week 12
Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12	Histologic Endoscopic Mucosal Improvement is defined as an Endoscopic Findings subscore ≤ 1 and Geboes score ≤ 3.1 (indicating neutrophil infiltration in < 5% of crypts, no crypt destruction and no erosions, ulcerations, or granulation tissue). 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). Geboes histologic remission is assessed using the Geboes histologic scores to identify histologic changes in ulcerative colitis. Possible scores are graded as Grade 0 to Grade 5, with higher grade representing higher levels of disease activity.	Week 12

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 11, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 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
• Other Study ID Numbers: GS-US-457-6411; 2022-501119-14 (Other Identifier: European Medicines Agency); jRCT2031230403 (Other Identifier: Japan Registry of Clinical Trials)

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