STATUS Recruitment Complete

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

See if you qualify OR Call 1-833-GIL-EAD 6

STATUS

Recruitment Complete

GILEAD STUDY ID

GS-US-409-5704

See if you qualify OR Call 1-833-GIL-EAD 6

LAST UPDATED

April 09, 2026

Clinicaltrials.gov ID

NCT06290934

CTSID

2023-508304-38

STUDY DOCUMENTS

View study documents

OVERVIEW

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) (SWIFT)

PROTOCOL 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.

Participation requirements

Age

18 years - 75 years

Sex

All

Healthy Volunteers

Study details

Medical Condition

Ulcerative Colitis

Gender

N/A

Date

March 2024 - March 2026

Study Type

Interventional

Study Phase

Phase 2

Product

emvistegrast, Placebo-to-match emvistegrast

Eligibility information

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)

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

Locations

Locations (181)

Onyx Clinical Research (Clinic Location)

Peoria, Arizona, United States, 85381

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

OVERVIEW

PROTOCOL SUMMARY

Participation requirements

Study details

Eligibility information

Inclusion criteria

Exclusion criteria

Locations

Locations (181)

Onyx Clinical Research (Clinic Location)

Om Research LLC

VVCRD Research

310 Clinical Research

US San Diego Health System

Om Research LLC

UCSF Benioff Children's Hospital Oakland

University Of California, Davis

SDG Clinical Research, LLC

Acclaim Clinical Research

Peak Gastroenterology Associates

Peak Gastroenterology Associates

Gastro Florida

Best Quality Research, Inc

United Research Institute LLC

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

Medical Professional Clinical Research Center, Inc.

Blessed Health Care & Research, Inc

Alliance Clinical Research of Tampa, LLC

Digestive and Liver Center of Florida, LLC

Clinical Research of Osceola

Encore Medical Research of Weston, LLC

EBGS Clinical Research Center

The University of Chicago Medical Center (Duchossois Center for Advanced Medicine)

Onyx Clinical Research

Robley Rex VA Medical Center

Louisiana Research Center, LLC

Johns Hopkins Bayview Medical Center

Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.

Mayo Clinic

Gastroenterology Associates of North Mississippi

Digestive Health Specialists (Clinic Visits)

St Charles Clinical Research

Tandem - Allied Clinical Research, LLC

N.Y. Total Medical Care, PC

NYU Langone Long Island Clinical Research Associates

Lenox Hill Hospital

NYU Grossman School of Medicne

Carolina Research

Piedmont Healthcare

Dayton Gastroenterology, LLC

Gastro Health Research

NexGen Research

Gastro Intestinal Research Institute of Northern Ohio, LLC

Penn State University Milton S. Hershey Medical Center

Skyline gastroenterology of west Tennessee

Quality Medical Research

Vanderbilt Inflammatory Bowel Disease Clinic

Gastroenterology Research of San Antonio

Amel Med Llc

GI Alliance - Mansfield

Clinical Associates in Research Therapeutics of America, LLC

Southern Star Research Institute, LLC.

Tyler Research Institute, LLC.

University of Virginia Medical Center

Emeritas Research Group

Gastroenterology Consultants of Southwest Virginia

Macquarie University

Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd

Princess Alexandra Hospital - Metro South Health

The Queen Elizabeth Hospital

Monash Health - Monash Medical Centre

Northern Hospital - Northern Health

Saint Vincent's Hospital Melbourne

Footscray Hospital - Westerm Health

Medical University Innsbruck, University Hospital for Internal Medicine I

Regional Hospital Salzburg, University Clinic for Internal Medicine I

Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology

Imeldaziekenhuis

AZ Groeninge