Clinical trial NCT06029972: Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2023-09-08
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 criteria: Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* Current diagnosis of Crohn's Disease (CD) or diagnosis of indeterminate colitis due to an enteric pathogen, lymphocytic or collagenous colitis.
* Individuals with disease limited to the rectum (ulcerative proctitis) during screening endoscopy.
* Requirement for ongoing therapy with or prior use of any prohibited medications.
* Active clinically significant infection, or any infection requiring hospitalization or treatment with intravenous anti-infectives within 8 weeks.

of randomization; or any infection requiring oral anti-infective therapy within 6 weeks of randomization.

* History of opportunistic infection.
* Current diagnosis of acute severe colitis, fulminant colitis, or toxic megacolon.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Primary outcomes:
measure: Proportion of Participants Achieving Clinical Response Per Modified Mayo Clinic Score at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Proportion of Participants Achieving Clinical Remission Per Modified Mayo Clinic Score at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Endoscopic Response at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Histologic Endoscopic Mucosal Improvement at Week 12
timeFrame: Week 12
measure: Percentage of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
timeFrame: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
measure: Percentage of Participants Experiencing Clinically Significant Laboratory Abnormalities
timeFrame: First dose date up to Week 52 (responders) or Week 64 (non-responders) plus 30 days
Other outcomes:
Locations:
city: Sun City
country: United States
facility: Arizona Digestive Health
state: Arizona
city: Chula Vista
country: United States
facility: GastroSb Weight Loss Clinic
state: California
city: Coronado
country: United States
facility: Southern California Research Centers
state: California
city: Garden Grove
country: United States
facility: VVCRD Research
state: California
city: La Jolla
country: United States
facility: UC San Diego Health System
state: California
city: Lancaster
country: United States
facility: Gastro Care Institute
state: California
city: Lancaster
country: United States
facility: Om Research LLC
state: California
city: Murrieta
country: United States
facility: United Medical Doctors
state: California
city: Sacramento
country: United States
facility: University of California, Davis
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Valencia
country: United States
facility: Amicis Research Center
state: California
city: Coral Gables
country: United States
facility: Luna Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Hollywood
country: United States
facility: The Medici Medical Research
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research, LLC
state: Florida
city: Largo
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: Wellness Research Center
state: Florida
city: Miami
country: United States
facility: IMIC Inc
state: Florida
city: Miami
country: United States
facility: Reserka LLC
state: Florida
city: Naples
country: United States
facility: GI PROS Research
state: Florida
city: Orlando
country: United States
facility: Revival Clinical Research
state: Florida
city: Orlando
country: United States
facility: Digestive and Liver Center of Florida, LLC
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Wellington
country: United States
facility: Gastroenterology Associates of Florida - GI Alliance
state: Florida
city: Decatur
country: United States
facility: Atlanta Center For Gastroenterology P.C.
state: Georgia
city: Grand Rapids
country: United States
facility: Corewell Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Oxford
country: United States
facility: Gastroenterology Associates of North Mississippi
state: Mississippi
city: Tupelo
country: United States
facility: Digestive Health Specialists
state: Mississippi
city: Saint Louis
country: United States
facility: St. Charles Clinical Research
state: Missouri
city: Brooklyn
country: United States
facility: Ellipsis Research Group
state: New York
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Canton
country: United States
facility: Gastroenterology & Hepatology Specialists Inc
state: Ohio
city: Cincinnati
country: United States
facility: Ohio Gastroenterology & Liver Institute
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Centre
state: Ohio
city: Dayton
country: United States
facility: Dayton Gastroenterology, LLC
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Jackson
country: United States
facility: Skyline Gastroenterology of West Tennessee
state: Tennessee
city: Boerne
country: United States
facility: Hill Country Digestive Health
state: Texas
city: El Paso
country: United States
facility: Gastroenterology Research of America
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Lubbock
country: United States
facility: Lubbock Digestive Disease Associates
state: Texas
city: Mansfield
country: United States
facility: GI Associates and Endoscopy Center - GI Alliance
state: Texas
city: Pearland
country: United States
facility: LinQ Research LLC
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC
state: Texas
city: Chesapeake
country: United States
facility: Gastroenterology Associates of Tidewater
state: Virginia
city: Lansdowne Town Center
country: United States
facility: Emeritas Group Research
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants of Southwest Virginia
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
city: South Brisbane
country: Australia
facility: Mater Adult Hospital
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Woodville
country: Australia
facility: Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Epping
country: Australia
facility: Northern Health
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Salzburg
country: Austria
facility: University of Salzburg, Universitätsklinik für Innere Medizin III
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
city: Leuven
country: Belgium
facility: Universitaire Ziekenhuis Leuven
city: London
country: Canada
facility: London Health Sciences Centre-University Hospital
city: Toronto
country: Canada
facility: Physician's Clinical Research, Inc. (PCRI)
city: Toronto
country: Canada
facility: Mount Sinai Hospital
city: Vaughan
country: Canada
facility: TDDA Speciality Research
city: Grenoble Cedex 9
country: France
facility: Centre Hospitalier Universitaire Grenoble
city: Little Cedex
country: France
facility: Hôpital Claude Huriez
city: Montpellier
country: France
facility: Hopital Saint Eloi
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Neuilly Sur Seine
country: France
facility: Institut des MICI
city: Saint-Etienne
country: France
facility: CHU de Saint Etienne - Hopital Nord
city: Toulouse
country: France
facility: Hopital Rangueil
city: Vandoeuvre Les Nancy
country: France
facility: CHRU Nancy
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin Campus CVK, Department of Hepatology and Gastroenterology
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Liepzig
country: Germany
facility: Eugastro Gmbh
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm Klinik fur Innere Medizin I CED Studien Ambulanz
city: Beri Balogh
country: Hungary
facility: Tolna Megye Balassa Janos Korhaz
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egyesitett Korhazak
city: Catanzaro
country: Italy
facility: AZIENDA UNICA OSPEDALIERO-UNIVERSITARIA"RENATO DULBECCO" - AOU"Mater Domini"
city: Milano
country: Italy
facility: IRCCS Istituto Clinico Humanitas
city: Roma
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
city: Hyogo
country: Japan
facility: Hyogo Medical University Hospital
city: Jonan-ku
country: Japan
facility: Fukuoka University Hospital
city: Minato-ku
country: Japan
facility: The Jikei University Hospital
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
city: Nagasaki
country: Japan
facility: Nagasaki University Hospital
city: Oita-shi
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology
city: Sagaken
country: Japan
facility: Saga University Hospital
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Toukiyouto
country: Japan
facility: Tokyo Medical And Dental University Hospital
city: Seodaemun-Gu
country: Korea, Republic of
facility: Yonsei University Severance Hospital
state: VIC
city: Busan
country: Korea, Republic of
facility: Inje University
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Jung-gu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
city: Katowice
country: Poland
facility: Economicus Sp. z o.o., Niepubliczny Zakład Opieki Zdrowotnej (NZOZ) ALL-MEDICUS
city: Krakow
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Rzeszów
country: Poland
facility: Kliniczny Szpital Wojewódzki Nr 2 im. Sw. Jadwigi Królowej w Rzeszowie
city: Sopot
country: Poland
facility: Specjalistyczna Praktyka Lekarska Leszek Bryniarski
city: Torun
country: Poland
facility: GASTROMED Kopon, Zmudzinski i wspolnicy Sp. J. Specialized Center of Gastroenterology and Endoscopy
city: Warszawa
country: Poland
facility: Medical Network Sp. z o.o. WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Nzoz Vivamed
city: Warszawa
country: Poland
facility: Specjalistyczne Gabinety Lekarskie Body Clinic
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Bern
country: Switzerland
facility: Intesto, Gastroenterologische Praxis Crohn-Colitis-Zentrum
city: Bury
country: United Kingdom
facility: Fairfield General Hospital
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital Nhs Foundation Trust
city: Southampton
country: United Kingdom
facility: University Hospital Southampton Nhs Foundation Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: