A Phase 2, Double-Blinded, Randomized, Placebo-Controlled, Dose-Ranging Study Evaluating the Efficacy and Safety of GS-5290 in Participants With Moderately to Severely Active Ulcerative Colitis

Status: Recruiting
Location: See all (123) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis. The study will compare participants in different treatment groups treated with tilpisertib fosmecarbil with participants treated with placebo. The primary objective of this study is to demonstrate the efficacy of tilpisertib fosmecarbil, compared to placebo control, in achieving Clinical Response at Week 12.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Individuals assigned male at birth, or nonpregnant, nonlactating individuals assigned female at birth, 18 to 75 years of age based on the date of the screening visit.

• Ulcerative colitis (UC) of at least 90-day duration before randomization confirmed by endoscopy and histology at any time in the past AND a minimum disease extent of 15 cm from the anal verge. Documentation of endoscopy and histology consistent with the diagnosis of UC must be available in the source documents prior to the initiation of screening.

• Moderately to severely active UC as determined during screening with a modified Mayo Clinic Score based on the sum of Stool Frequency, Rectal Bleeding, and Endoscopic Finding of 5 to 9 points and an endoscopic subscore of 2 to 3 (determined by central reader).

• Previous treatment history of approved UC therapy with at least one advanced therapy mechanisms of action but failure (ie, loss of response or lack of response) of no more than 3 different advanced therapy mechanisms of action.

• A surveillance colonoscopy for dysplasia is required prior to randomization if indicated by regional guidelines for individuals with UC.

Locations
United States
Arizona
Arizona Digestive Health
RECRUITING
Sun City
California
GastroSb Weight Loss Clinic
RECRUITING
Chula Vista
Southern California Research Centers
RECRUITING
Coronado
VVCRD Research
RECRUITING
Garden Grove
UC San Diego Health System
RECRUITING
La Jolla
Gastro Care Institute
RECRUITING
Lancaster
Om Research LLC
RECRUITING
Lancaster
United Medical Doctors
WITHDRAWN
Murrieta
University of California, Davis
RECRUITING
Sacramento
University of California San Francisco
RECRUITING
San Francisco
Amicis Research Center
RECRUITING
Valencia
Florida
Luna Research
RECRUITING
Coral Gables
University of Florida
RECRUITING
Gainesville
Encore Medical Research, LLC
RECRUITING
Hollywood
The Medici Medical Research
RECRUITING
Hollywood
Florida Research Institute
RECRUITING
Largo
IMIC Inc
RECRUITING
Miami
Reserka LLC
RECRUITING
Miami
Wellness Research Center
WITHDRAWN
Miami
GI PROS Research
RECRUITING
Naples
Digestive and Liver Center of Florida, LLC
RECRUITING
Orlando
Revival Clinical Research
RECRUITING
Orlando
Advanced Medical Research Center
RECRUITING
Port Orange
Gastroenterology Associates of Florida - GI Alliance
WITHDRAWN
Wellington
Georgia
Atlanta Center For Gastroenterology P.C.
RECRUITING
Decatur
Michigan
Corewell Health
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic
RECRUITING
Rochester
Missouri
St. Charles Clinical Research
RECRUITING
St Louis
Mississippi
Gastroenterology Associates of North Mississippi
RECRUITING
Oxford
Digestive Health Specialists
RECRUITING
Tupelo
New York
Ellipsis Research Group
ACTIVE_NOT_RECRUITING
Brooklyn
NYU Langone Long Island Clinical Research Associates
RECRUITING
Great Neck
Ohio
Gastroenterology & Hepatology Specialists Inc
RECRUITING
Canton
Ohio Gastroenterology & Liver Institute
RECRUITING
Cincinnati
The Ohio State University Wexner Medical Centre
RECRUITING
Columbus
Dayton Gastroenterology, LLC
RECRUITING
Dayton
Great Lakes Gastroenterology Research, LLC
RECRUITING
Mentor
Tennessee
Skyline Gastroenterology of West Tennessee
NOT_YET_RECRUITING
Jackson
Texas
Hill Country Digestive Health
RECRUITING
Boerne
Gastroenterology Research of America
WITHDRAWN
El Paso
DHAT Research Institute
RECRUITING
Garland
Southwest Clinical Trials
WITHDRAWN
Houston
Lubbock Digestive Disease Associates
RECRUITING
Lubbock
GI Associates and Endoscopy Center - GI Alliance
RECRUITING
Mansfield
LinQ Research LLC
RECRUITING
Pearland
Clinical Associates in Research Therapeutics of America
RECRUITING
San Antonio
Gastroenterology Research of San Antonio
RECRUITING
San Antonio
Tyler Research Institute, LLC
RECRUITING
Tyler
Virginia
Gastroenterology Associates of Tidewater
RECRUITING
Chesapeake
Emeritas Group Research
RECRUITING
Lansdowne Town Center
Gastroenterology Consultants of Southwest Virginia
NOT_YET_RECRUITING
Roanoke
Washington
Swedish Medical Center
RECRUITING
Seattle
Other Locations
Australia
Royal Adelaide Hospital
RECRUITING
Adelaide
Monash Medical Centre
RECRUITING
Clayton
Northern Health
RECRUITING
Epping
Footscray Hospital
RECRUITING
Footscray
Mater Adult Hospital
RECRUITING
South Brisbane
Queen Elizabeth Hospital
RECRUITING
Woodville
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Austria
Medical University of Innsbruck
RECRUITING
Innsbruck
University of Salzburg, Universitätsklinik für Innere Medizin III
NOT_YET_RECRUITING
Salzburg
Universitätsklinikum St. Pölten
RECRUITING
Sankt Pölten
Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
RECRUITING
Vienna
Belgium
Universitaire Ziekenhuis Leuven
RECRUITING
Leuven
Canada
London Health Sciences Centre-University Hospital
RECRUITING
London
Mount Sinai Hospital
RECRUITING
Toronto
Physician's Clinical Research, Inc. (PCRI)
WITHDRAWN
Toronto
TDDA Speciality Research
RECRUITING
Vaughan
France
Centre Hospitalier Universitaire Grenoble
RECRUITING
Grenoble
Hôpital Claude Huriez
RECRUITING
Little Cedex
Hopital Saint Eloi
RECRUITING
Montpellier
Centre Hospitalier Universitaire de Nantes
RECRUITING
Nantes
Institut des MICI
RECRUITING
Neuilly-sur-seine
CHU de Saint Etienne - Hopital Nord
RECRUITING
Saint-etienne
Hopital Rangueil
RECRUITING
Toulouse
CHRU Nancy
RECRUITING
Vandœuvre-lès-nancy
Germany
Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
NOT_YET_RECRUITING
Berlin
Medizinische Hochschule Hannover
NOT_YET_RECRUITING
Hanover
Universitatsklinikum Schleswig-Holstein
RECRUITING
Kiel
Eugastro Gmbh
RECRUITING
Liepzig
Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
NOT_YET_RECRUITING
Ulm
Hungary
Tolna Megye Balassa Janos Korhaz
RECRUITING
Beri Balogh
Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
RECRUITING
Budapest
Italy
AZIENDA UNICA OSPEDALIERO-UNIVERSITARIARENATO DULBECCO - AOUMater Domini
RECRUITING
Catanzaro
IRCCS Istituto Clinico Humanitas
RECRUITING
Milan
Azienda Ospedaliera San Camillo Forlanini
RECRUITING
Roma
Istituto Clinico Humanitas
RECRUITING
Rozzano
Azienda Sanitaria Universitaria Friuli Centrale
NOT_YET_RECRUITING
Udine
Japan
Hyogo Medical University Hospital
RECRUITING
Hyōgo
Fukuoka University Hospital
RECRUITING
Jonan-ku
Kitasato University Kitasato Institute Hospital
RECRUITING
Minatoku
The Jikei University Hospital
RECRUITING
Minatoku
Kyorin University Hospital
RECRUITING
Mitaka-shi
Nagasaki University Hospital
RECRUITING
Nagasaki
Ishida Clinic of IBD and Gastroenterology
RECRUITING
Ōita
Saga University Hospital
RECRUITING
Sagaken
Kitasato University Hospital
NOT_YET_RECRUITING
Sagamihara
Sapporo Medical University Hospital
RECRUITING
Sapporo
Tokyo Medical And Dental University Hospital
RECRUITING
Toukiyouto
Poland
Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
RECRUITING
Katowice
Gabinet Endoskopii Przewodu Pokarmowego
RECRUITING
Krakow
Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
RECRUITING
Rzeszów
Specjalistyczna Praktyka Lekarska Leszek Bryniarski
RECRUITING
Sopot
GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
RECRUITING
Torun
Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
RECRUITING
Warsaw
Nzoz Vivamed
RECRUITING
Warsaw
Specjalistyczne Gabinety Lekarskie Body Clinic
RECRUITING
Warsaw
Centrum Medyczne Oporow
RECRUITING
Wroclaw
Republic of Korea
Inje University
RECRUITING
Busan
Yeungnam University Hospital
RECRUITING
Daegu
Kyungpook National University Hospital
RECRUITING
Junggu
Yonsei University Severance Hospital
RECRUITING
Seodaemun-gu
Hanyang University Hospital
RECRUITING
Seoul
Kangbuk Samsung Hospital
RECRUITING
Seoul
Kyung Hee University Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Wonju Severance Christian Hospital
RECRUITING
Wŏnju
Switzerland
Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
RECRUITING
Bern
United Kingdom
Fairfield General Hospital
RECRUITING
Bury
Cambridge University Hospitals NHS Foundation Trust
RECRUITING
Cambridge
Barts Health NHS Trust
RECRUITING
London
Norfolk and Norwich University Hospital Nhs Foundation Trust
RECRUITING
Norwich
University Hospital Southampton Nhs Foundation Trust
RECRUITING
Southampton
Contact Information
Primary
Gilead Clinical Study Information Center
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)
Time Frame
Start Date: 2023-12-05
Estimated Completion Date: 2027-05
Participants
Target number of participants: 176
Treatments
Experimental: Tilpisertib Fosmecarbil Dose A
Blinded Treatment Phase:~Participants will receive tilpisertib fosmecarbil Dose A for up to 12 weeks. An efficacy assessment will be performed at Week 12.~• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52.~Non-responder Treatment Phase:~• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Experimental: Tilpisertib Fosmecarbil Dose B
Blinded Treatment Phase:~Participants will receive tilpisertib fosmecarbil Dose B for up to 12 weeks. An efficacy assessment will be performed at Week 12.~• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52.~Non-responder Treatment Phase:~• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Experimental: Tilpisertib Fosmecarbil Dose C
Blinded Treatment Phase:~Participants will receive tilpisertib fosmecarbil Dose C for up to 12 weeks. An efficacy assessment will be performed at Week 12.~• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52.~Non-responder Treatment Phase:~• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose B for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved clinical response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve clinical response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Placebo_comparator: Tilpisertib Fosmecarbil Placebo
Blinded Treatment Phase:~Participants will receive tilpisertib fosmecarbil placebo for up to 12 weeks. An efficacy assessment will be performed at Week 12.~• Participants who achieve clinical response will receive tilpisertib fosmecarbil Dose C for up to Week 52.~Non-responder Treatment Phase:~• Participants who do not achieve clinical response at Week 12 will discontinue the Blinded Treatment Phase and have the option to enter into the Non-responder Treatment Phase. Participants will receive tilpisertib fosmecarbil Dose A for another 12 weeks. An efficacy assessment will be performed at Week 12 of the Non-responder Treatment Phase. Participants who achieved Clinical Response will receive tilpisertib fosmecarbil Dose B for up to Week 52. Participants who do not achieve Clinical Response at Non-responder Treatment Phase Week 12 will discontinue study drug.
Sponsors
Leads: Gilead Sciences

This content was sourced from clinicaltrials.gov

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