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Clinical Trials in the UK / NCT06290934
Active, not recruiting Phase 2

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

NCT06290934 · tracked via the Priya Life Science UK tracker
Sponsor
Gilead Sciences
Phase
Phase 2
Started
2024-03-27
Last updated
2026-04-09

Condition(s) studied

Ulcerative Colitis

Investigational drug(s) / intervention(s)

emvistegrastPlacebo-to-match emvistegrast

emvistegrast: Administered orally

Placebo-to-match emvistegrast: Administered orally

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (181)

FacilityCityRegionStatus
Onyx Clinical Research (Clinic Location) Peoria Arizona
Om Research LLC Camarillo California
VVCRD Research Garden Grove California
310 Clinical Research Inglewood California
US San Diego Health System La Jolla California
Om Research LLC Lancaster California
UCSF Benioff Children's Hospital Oakland Oakland California
University Of California, Davis Sacramento California
SDG Clinical Research, LLC San Diego California
Acclaim Clinical Research San Diego California
Peak Gastroenterology Associates Colorado Springs Colorado
Peak Gastroenterology Associates Colorado Springs Colorado
Gastro Florida Clearwater Florida
Best Quality Research, Inc Hialeah Florida
United Research Institute LLC Hialeah Florida
University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy Miami Florida
Medical Professional Clinical Research Center, Inc. Miami Florida
Blessed Health Care & Research, Inc Miami Florida
Alliance Clinical Research of Tampa, LLC New Port Richey Florida
Digestive and Liver Center of Florida, LLC Orlando Florida
Clinical Research of Osceola Orlando Florida
Encore Medical Research of Weston, LLC Weston Florida
EBGS Clinical Research Center Snellville Georgia
The University of Chicago Medical Center (Duchossois Center for Advanced Medicine) Chicago Illinois
Onyx Clinical Research Peoria Illinois
Robley Rex VA Medical Center Louisville Kentucky
Louisiana Research Center, LLC Shreveport Louisiana
Johns Hopkins Bayview Medical Center Baltimore Maryland
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center. Wyoming Michigan
Mayo Clinic Rochester Minnesota
Gastroenterology Associates of North Mississippi Oxford Mississippi
Digestive Health Specialists (Clinic Visits) Tupelo Mississippi
St Charles Clinical Research Weldon Spring Missouri
Tandem - Allied Clinical Research, LLC Freehold New Jersey
N.Y. Total Medical Care, PC Brooklyn New York
NYU Langone Long Island Clinical Research Associates Great Neck New York
Lenox Hill Hospital Manhasset New York
NYU Grossman School of Medicne New York New York
Carolina Research Greenville North Carolina
Piedmont Healthcare Statesville North Carolina

+ 141 more sites — see the full list on the official registry below.

More Gilead Sciences trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06290934 on ClinicalTrials.gov ↗ ← All trials in the UK