ACTIVE_NOT_RECRUITING

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

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Conditions

Ulcerative Colitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The goal of this study is to learn if GS-1427 is effective in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with GS-1427 with participants treated with placebo. The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.

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)

Quick Facts

Study Start:2024-03-27
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06290934

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Individuals have UC with minimum disease extent of 15 cm from the anal verge.
  3. * 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.
  4. * 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.
  5. * 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)
  1. * 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.
  2. * Have a current diagnosis of toxic megacolon, symptomatic colonic stricture, acute severe colitis, fulminant colitis, or abdominal abscess at screening or randomization.
  3. * Have any history of exposure to vedolizumab or other integrin antagonists
  4. * Requirement for ongoing therapy with or use of any prohibited medication as specified in the protocol

Contacts and Locations

Principal Investigator

Gilead Study Director
STUDY_DIRECTOR
Gilead Sciences

Study Locations (Sites)

Onyx Clinical Research (Clinic Location)
Peoria, Arizona, 85381
United States
Om Research LLC
Camarillo, California, 93010
United States
VVCRD Research
Garden Grove, California, 92845
United States
310 Clinical Research
Inglewood, California, 90301
United States
US San Diego Health System
La Jolla, California, 92037
United States
Om Research LLC
Lancaster, California, 93534
United States
UCSF Benioff Children's Hospital Oakland
Oakland, California, 94609
United States
University Of California, Davis
Sacramento, California, 95817
United States
SDG Clinical Research, LLC
San Diego, California, 92103
United States
Acclaim Clinical Research
San Diego, California, 92120
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907
United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80921
United States
Gastro Florida
Clearwater, Florida, 33756
United States
Best Quality Research, Inc
Hialeah, Florida, 33016
United States
United Research Institute LLC
Hialeah, Florida, 33016
United States
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
Miami, Florida, 33136
United States
Medical Professional Clinical Research Center, Inc.
Miami, Florida, 33155
United States
Blessed Health Care & Research, Inc
Miami, Florida, 33173
United States
Alliance Clinical Research of Tampa, LLC
New Port Richey, Florida, 34653
United States
Digestive and Liver Center of Florida, LLC
Orlando, Florida, 32825
United States
Clinical Research of Osceola
Orlando, Florida, 34741
United States
Encore Medical Research of Weston, LLC
Weston, Florida, 33331
United States
EBGS Clinical Research Center
Snellville, Georgia, 30078
United States
The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)
Chicago, Illinois, 60637
United States
Onyx Clinical Research
Peoria, Illinois, 85381
United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206
United States
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
United States
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
United States
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
Wyoming, Michigan, 49519
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Gastroenterology Associates of North Mississippi
Oxford, Mississippi, 38655
United States
Digestive Health Specialists (Clinic Visits)
Tupelo, Mississippi, 38801
United States
St Charles Clinical Research
Weldon Spring, Missouri, 63304
United States
Tandem - Allied Clinical Research, LLC
Freehold, New Jersey, 07728
United States
N.Y. Total Medical Care, PC
Brooklyn, New York, 11215
United States
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021
United States
Lenox Hill Hospital
Manhasset, New York, 11030
United States
NYU Grossman School of Medicne
New York, New York, 10016
United States
Carolina Research
Greenville, North Carolina, 27834
United States
Piedmont Healthcare
Statesville, North Carolina, 28625
United States
Dayton Gastroenterology, LLC
Beavercreek, Ohio, 45440
United States
Gastro Health Research
Cincinnati, Ohio, 45219
United States
NexGen Research
Lima, Ohio, 45801
United States
Gastro Intestinal Research Institute of Northern Ohio, LLC
Westlake, Ohio, 44145
United States
Penn State University Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States
Skyline gastroenterology of west Tennessee
Jackson, Tennessee, 38301
United States
Quality Medical Research
Nashville, Tennessee, 37211
United States
Vanderbilt Inflammatory Bowel Disease Clinic
Nashville, Tennessee, 37232
United States
Gastroenterology Research of San Antonio
Fredericksburg, Texas, 78624
United States
Amel Med Llc
Georgetown, Texas, 78628
United States
GI Alliance - Mansfield
Mansfield, Texas, 76063
United States
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212
United States
Southern Star Research Institute, LLC.
San Antonio, Texas, 78229
United States
Tyler Research Institute, LLC.
Tyler, Texas, 75701
United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908
United States
Emeritas Research Group
Lansdowne Town Center, Virginia, 20176
United States
Gastroenterology Consultants of Southwest Virginia
Roanoke, Virginia, 24014
United States

Collaborators and Investigators

Sponsor: Gilead Sciences

  • Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-27
Study Completion Date2027-07

Study Record Updates

Study Start Date2024-03-27
Study Completion Date2027-07

Terms related to this study

Additional Relevant MeSH Terms

  • Ulcerative Colitis