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

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.

Conditions

Ulcerative Colitis

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Study Overview

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Study Details

Study overview

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.

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)

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

Condition
Ulcerative Colitis
Intervention / Treatment

-

Contacts and Locations

Camarillo

Om Research LLC, Camarillo, California, United States, 93010

Garden Grove

VVCRD Research, Garden Grove, California, United States, 92845

La Jolla

US San Diego Health System, La Jolla, California, United States, 92037

Lancaster

Om Research LLC, Lancaster, California, United States, 93534

Murrieta

United Medical Doctors, Murrieta, California, United States, 92563

Oakland

UCSF Benioff Children's Hospital Oakland, Oakland, California, United States, 94609

Colorado Springs

Peak Gastroenterology Associates, Colorado Springs, Colorado, United States, 80907

Hialeah

United Research Institute LLC, Hialeah, Florida, United States, 33016

Hollywood

Encore Medical Research. LLC, Hollywood, Florida, United States, 33021

Miami

University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy, Miami, Florida, United States, 33136

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Gilead Sciences,

Gilead Study Director, STUDY_DIRECTOR, Gilead Sciences

Study Record Dates

2027-02