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

LAST UPDATED

October 18 2024

Clinicaltrials.gov ID

NCT06290934

OVERVIEW

A Multicenter, Randomized, Double-blind, 2-Part Phase 2 Study to Evaluate the Efficacy and Safety of GS-1427 in Adult Participants With Moderately to Severely Active Ulcerative Colitis (UC) Part 1: Placebo-Controlled, Dose-Ranging Study of GS-1427; Part 2: Active-Controlled, Combination Study Evaluating the Efficacy and Safety of GS-1427 in Combination With Ustekinumab Versus GS-1427 or Ustekinumab Monotherapy (SWIFT)

PROTOCOL SUMMARY

The goal of this study is to learn if GS-1427 is effective and safe 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 (Part 1), and participants treated with GS-1427 or ustekinumab alone with participants treated with GS-1427 in combination with ustekinumab (Part 2). The primary objectives of this study are: Part 1: To assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12 Part 2: To assess the efficacy of combination therapy with GS-1427 and ustekinumab, compared with GS-1427 and ustekinumab monotherapies, in achieving clinical response at Week 12

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Participation Requirements

Calendar

Age

18 Years - 75 Years

Condition

Sex

ALL

Healthy Icon

Healthy Volunteers

No

Study Details

Medical Condition

Ulcerative Colitis

Gender

N/A

Date

March 2024 - May 2027

Study Type

INTERVENTIONAL

Study Phase

PHASE2

Product

GS-1427, Ustekinumab, Placebo-to-match GS-1427

Eligibility Information

Inclusion

Inclusion Criteria

  • * Individuals have Ulcerative Colitis (UC) of at least 90-days duration before randomization confirmed by endoscopy and histology at any time in the past. 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 is intolerant to at least 1 of the following conventional UC treatments
  • * Individuals have an inadequate response or loss of response or are intolerant to:
  • * At least one of these conventional UC treatments: Corticosteroids, azathioprine or 6-mercaptopurine (6-MP)
  • OR
  • * No more than two advanced therapies: Tumor necrosis factor-alpha inhibitors, interleukin (IL)-12/23 inhibitors (Part 1 only; no prior use in Part 2), sphingosine 1-phosphate receptor modulators, and Janus kinase inhibitors
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Exclusion

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.
  • * Part 1 and 2; have any history of exposure to vedolizumab
  • * Part 2 only: have any history of exposure to interleukin - 12/23 or 23 inhibitor (eg ustekinumab)
  • * 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
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Locations

Locations (68)
Recruiting

Om Research LLC

Camarillo, California, United States, 93010

Recruiting

VVCRD Research

Garden Grove, California, United States, 92845

Recruiting

Om Research LLC

Lancaster, California, United States, 93534

Recruiting

United Medical Doctors

Murrieta, California, United States, 92563

Recruiting

UCSF Benioff Children's Hospital Oakland

Oakland, California, United States, 94609

Recruiting

United Research Institute LLC

Hialeah, Florida, United States, 33016

Recruiting

Encore Medical Research. LLC

Hollywood, Florida, United States, 33021

Recruiting

Advance Research Center

Miami, Florida, United States, 33183

Recruiting

USF Health Morsani Center for Advanced Healthcare

Tampa, Florida, United States, 33612

Recruiting

Encore Medical Research of Weston, LLC

Weston, Florida, United States, 33331

Recruiting

Atlanta Center for Gastroenterology, P.C.

Decatur, Georgia, United States, 30033

Recruiting

Louisiana Research Center, LLC

Shreveport, Louisiana, United States, 71105

Recruiting

Clinical Research Institute of Michigan, LLC.

Chesterfield, Michigan, United States, 48047

Recruiting

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

Wyoming, Michigan, United States, 49519

Recruiting

Mayo Clinic

Rochester, Minnesota, United States, 55905

Recruiting

St Charles Clinical Research

Saint Louis, Missouri, United States, 63141

Recruiting

N.Y. Total Medical Care, PC

Brooklyn, New York, United States, 11215

Recruiting

Lenox Hill Hospital

Manhasset, New York, United States, 11030

Recruiting

NYU Grossman School of Medicne

New York, New York, United States, 10016

Recruiting

Piedmont Healthcare

Statesville, North Carolina, United States, 28625

Recruiting

Gastro Intestinal Research Institute of Northern Ohio, LLC

Westlake, Ohio, United States, 44145

Recruiting

Penn State University Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Recruiting

Care Access - Pottsville

Pottsville, Pennsylvania, United States, 17901

Recruiting

Quality Medical Research

Nashville, Tennessee, United States, 37211

Recruiting

Vanderbilt Inflammatory Bowel Disease Clinic

Nashville, Tennessee, United States, 37232

Recruiting

Gastroenterology Research of San Antonio

Fredericksburg, Texas, United States, 78624

Recruiting

Southwest Clinical Trials

Houston, Texas, United States, 77074

Recruiting

GI Alliance - Mansfield

Mansfield, Texas, United States, 76063

Recruiting

Clinical Associates in Research Therapeutics of America, LLC

San Antonio, Texas, United States, 78212

Recruiting

Southern Star Research Institute, LLC.

San Antonio, Texas, United States, 78229

Recruiting

Tyler Research Institute, LLC.

Tyler, Texas, United States, 75701

Recruiting

University of Virginia Medical Center

Charlottesville, Virginia, United States, 22908

Recruiting

Macquarie University

Sydney, New South Wales, Australia, 2109

Recruiting

Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd

South Brisbane, Queensland, Australia, 4101

Recruiting

Princess Alexandra Hospital - Metro South Health

Woolloongabba, Queensland, Australia, 4102

Recruiting

Monash Health - Monash Medical Centre

Clayton, Victoria, Australia, 3168

Recruiting

Northern Hospital - Northern Health

Epping, Victoria, Australia, 3076

Recruiting

Saint Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia, 3065

Recruiting

Footscray Hospital - Westerm Health

Footscray, Victoria, Australia, 3011

Recruiting

TDDA Specialty Reserach

Vaughan, Canada, L4L 4Y7

Recruiting

ARENSIA Exploratory Medicine

Tbilisi, Georgia, 112

Recruiting

Queen Mary Hospital

Hong Kong, Hong Kong

Recruiting

Inje University Haeundae Paik Hospital IRB

Busan, Korea, Republic of, 48108

Recruiting

Kyungpook National University Hospital

Daegu, Korea, Republic of, 41944

Recruiting

Kyung Hee University Hospital

Guri-Si, Korea, Republic of, 471-701

Recruiting

Kangbuk Samsung Hospital

Jongno-Gu, Korea, Republic of, 03181

Recruiting

Yeungnam University Hospital

Nam-Gu, Korea, Republic of, 42415

Recruiting

Asan Medical Center

Seoul, Korea, Republic of, 05505

Recruiting

Samsung Medical Center

Seoul, Korea, Republic of, 6351

Recruiting

Yonsei University Wonju Severance Christian Hospital

Wonju, Korea, Republic of, 220-701

Recruiting

Hospital Universiti Sains Malaysia

Kelantan, Malaysia, 16150

Recruiting

Hospital Queen Elizabeth

Kota Kinabalu, Malaysia, 88586

Recruiting

Hospital Tengku Ampuan Afzan

Kuantan, Malaysia, 25100

Recruiting

Sultan Ahmad Shah Medical Centre @IIUM

Kuantan, Malaysia, 25200

Recruiting

Hospital Sultan Idris Shah Serdang

Selangor, Malaysia, 43000

Recruiting

PMSI Clinical Republican Hospital "Timofei Molneaga"

Chisinau, Moldova, Republic of, MD-2025

Recruiting

Endoskopia Sp. z.o.o.

Kraków, Poland, 30-082

Recruiting

Krakowskie Centrum Medyczne Sp. z o.o.

Kraków, Poland, 31-501

Recruiting

Centrum Innowacyjnych Terapii Sp. z o.o.

Mazowieckie, Poland, 05-500

Recruiting

Centrum Medyczne Medyk Sp. z 0.0. sp.k.

Rzeszów, Poland, 35-301

Recruiting

H-T Centrum Medyczne - Endoterapia

Tychy, Poland, 43-100

Recruiting

Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Poland, 00-728

Recruiting

Bodyclinic Sp. z o.o. sp.k.

Warszawa, Poland, 00-332

Recruiting

Changhua Christian Hospital

Changhua City, Taiwan, 505

Recruiting

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung, Taiwan, 807

Recruiting

China Medical University Hospital

Taichung, Taiwan, 404327

Recruiting

National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100

Taipei, Taiwan, 100

Recruiting

Taipei Veterans General Hospital

Taipei, Taiwan, 11217