Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Launched by GILEAD SCIENCES · Mar 1, 2024
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new treatment called GS-1427 for people with moderately to severely active ulcerative colitis, a condition that causes inflammation in the digestive tract. The main goal is to find out if GS-1427 is effective and safe compared to a placebo (a non-active treatment) and to see how it works when combined with another medication called ustekinumab. Participants will be placed in different groups to receive either GS-1427 alone, ustekinumab alone, or both together, and their responses will be assessed after 12 weeks.
To be eligible for this trial, participants need to have been diagnosed with ulcerative colitis for at least 90 days and have certain levels of disease activity as determined by medical examinations. They should also have had insufficient results from at least one standard treatment for their condition. Participants can expect regular visits to the clinic for assessments and monitoring throughout the study. It’s important to note that individuals with certain other bowel conditions or those who have previously received specific treatments may not qualify for this trial. Overall, this study aims to explore new options for managing ulcerative colitis and improve the quality of life for those affected by it.
Gender
ALL
Eligibility criteria
- 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
About Gilead Sciences
Gilead Sciences is a leading biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines to address unmet medical needs. With a strong emphasis on antiviral therapies, particularly for HIV, hepatitis B, hepatitis C, and influenza, Gilead leverages advanced research and development capabilities to drive breakthroughs in treatment and care. The company is committed to improving patient outcomes through rigorous clinical trials, fostering collaborations with healthcare professionals, and engaging in partnerships to enhance global health. Gilead's dedication to scientific excellence and patient-centric approaches positions it at the forefront of the biopharmaceutical industry.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rochester, Minnesota, United States
Baltimore, Maryland, United States
Hong Kong, , Hong Kong
Sacramento, California, United States
Christchurch, , New Zealand
Oakland, California, United States
Kortrijk, , Belgium
Charlottesville, Virginia, United States
Sydney, New South Wales, Australia
Woodville, South Australia, Australia
Taichung, , Taiwan
Sevilla, , Spain
Hong Kong, , Hong Kong
Kaohsiung, , Taiwan
Greenville, North Carolina, United States
Nashville, Tennessee, United States
Seoul, , Korea, Republic Of
Bucuresti, , Romania
Bonheiden, , Belgium
Hong Kong, , Hong Kong
Decatur, Georgia, United States
Taipei, , Taiwan
Houston, Texas, United States
Daegu, , Korea, Republic Of
Statesville, North Carolina, United States
Kuantan, , Malaysia
Seoul, , Korea, Republic Of
Valencia, , Spain
Shreveport, Louisiana, United States
Hershey, Pennsylvania, United States
Tampa, Florida, United States
Clayton, Victoria, Australia
Olomouc, , Czechia
Colorado Springs, Colorado, United States
Slany, , Czechia
Kelantan, , Malaysia
Seoul, , Korea, Republic Of
Lansdowne Town Center, Virginia, United States
Fitzroy, Victoria, Australia
Kota Bharu, Kelantan, Malaysia
San Antonio, Texas, United States
Kota Kinabalu, , Malaysia
Wonju, , Korea, Republic Of
Ksawerów, , Poland
Garden Grove, California, United States
Guri Si, , Korea, Republic Of
Kraków, , Poland
Johor Bahru, , Malaysia
Wroclaw, , Poland
Murrieta, California, United States
Clearwater, Florida, United States
Huelva, , Spain
Lancaster, California, United States
Poznan, , Poland
Roanoke, Virginia, United States
Warszawa, , Poland
Hexham, , United Kingdom
San Antonio, Texas, United States
Weston, Florida, United States
San Diego, California, United States
Pottsville, Pennsylvania, United States
Sint Niklaas, , Belgium
Taichung, , Taiwan
Weldon Spring, Missouri, United States
Suwon Si, , Korea, Republic Of
Budapest, , Hungary
Satu Mare, , Romania
Cincinnati, Ohio, United States
Hialeah, Florida, United States
Inglewood, California, United States
Lublin, , Poland
Mansfield, Texas, United States
Kajang, Selangor, Malaysia
Nashville, Tennessee, United States
Taipei, Zhongshan, Taiwan
Hollywood, Florida, United States
Chesterfield, Michigan, United States
Tyler, Texas, United States
Cambridge, , United Kingdom
Camarillo, California, United States
Wyoming, Michigan, United States
Snellville, Georgia, United States
Miami, Florida, United States
Saint Louis, Missouri, United States
Hialeah, Florida, United States
Fredericksburg, Texas, United States
Georgetown, Texas, United States
Orlando, Florida, United States
Oxford, Mississippi, United States
Beavercreek, Ohio, United States
Vaughan, , Canada
Chisinau, , Moldova, Republic Of
Taipei, , Taiwan
Westlake, Ohio, United States
Brooklyn, New York, United States
Manhasset, New York, United States
New York, New York, United States
South Brisbane, Queensland, Australia
Epping, Victoria, Australia
Footscray, Victoria, Australia
Tbilisi, , Georgia
Jongno Gu, , Korea, Republic Of
Lima, Ohio, United States
Woolloongabba, Queensland, Australia
Busan, , Korea, Republic Of
Jongno Gu, , Korea, Republic Of
Nam Gu, , Korea, Republic Of
Kuantan, , Malaysia
Selangor, , Malaysia
Kraków, , Poland
Mazowieckie, , Poland
Rzeszów, , Poland
Tychy, , Poland
Warsaw, , Poland
Warszawa, , Poland
Changhua City, , Taiwan
La Jolla, California, United States
Miami, Florida, United States
Petaling Jaya, , Malaysia
Szczecin, , Poland
Wroclaw, , Poland
Taoyuan City, , Taiwan
San Diego, California, United States
New Port Richey, Florida, United States
Katowice, , Poland
Poznań, , Poland
Torun, , Poland
Warsaw, , Poland
Wrocław, , Poland
Cardiff, , United Kingdom
Peoria, Arizona, United States
Orlando, Florida, United States
Tupelo, Mississippi, United States
Jackson, Tennessee, United States
Innsbruck, , Austria
Vienna, , Austria
Nantes, , France
Pierre Benite, , France
Budapest, , Hungary
Budapest, , Hungary
Bucharest, , Romania
Cluj Napoca, , Romania
Timisoara, , Romania
Bologna, , Italy
Halle (Saale), , Germany
Kiel, , Germany
Milano, , Italy
Roma, , Italy
Daejeon, , Korea, Republic Of
Seongdong Gu, , Korea, Republic Of
Miami, Florida, United States
Miami, Florida, United States
Freehold, New Jersey, United States
Ulm, , Germany
Bury, , United Kingdom
Catanzaro, , Italy
Palermo, , Italy
La Tronche, , France
București, , Romania
Ferrol, , Spain
Bristol, , United Kingdom
Dresden, , Germany
Halle (Saale), , Germany
Bydgoszcz, , Poland
Kraków, , Poland
Szczecin, , Poland
București, , Romania
Cluj Napoca, , Romania
Constanta, , Romania
Timisoara, , Romania
Belgrade, , Serbia
Belgrade, , Serbia
Beograd, , Serbia
Zrenjanin, , Serbia
Patients applied
Trial Officials
Gilead Study Director
Study Director
Gilead Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported