Clinical trial NCT06290934: Study of GS-1427 in Participants With Moderately to Severely Active Ulcerative Colitis
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2024-03-04
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to learn if GS-1427 is effective 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.

The primary objective of this study is to assess the efficacy of GS-1427, compared with placebo control, in achieving clinical response at Week 12.


Eligibility criteria: 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 outcomes:
measure: Proportion of Participants Achieving Clinical Response at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Incidence of Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), or Deaths.
timeFrame: First dose date up to 76 weeks plus 28 days
measure: Incidence of Treatment-emergent Lab Abnormalities
timeFrame: First dose date up to 76 weeks plus 28 days
measure: Proportion of Participants Achieving Clinical Remission at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Clinical Remission at Week 52
timeFrame: Week 52
measure: Proportion of Participants Achieving Histologic-endoscopic Mucosal Improvement at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Mucosal Healing at Week 12
timeFrame: Week 12
measure: Proportion of Participants Achieving Endoscopic Improvement at Week 12
timeFrame: Week 12
measure: To Assess the Efficacy of GS-1427 in Achieving Partial Modified Mayo Clinic Score (mMCS) remission at Week 76
timeFrame: Week 76
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Onyx Clinical Research (Clinic Location)
state: Arizona
city: Camarillo
country: United States
facility: Om Research LLC
state: California
city: Garden Grove
country: United States
facility: VVCRD Research
state: California
city: Inglewood
country: United States
facility: 310 Clinical Research
state: California
city: La Jolla
country: United States
facility: US San Diego Health System
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: Oakland
country: United States
facility: UCSF Benioff Children's Hospital Oakland
state: California
city: San Diego
country: United States
facility: SDG Clinical Research, LLC
state: California
city: San Diego
country: United States
facility: Acclaim Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Peak Gastroenterology Associates
state: Colorado
city: Clearwater
country: United States
facility: Gastro Florida
state: Florida
city: Hialeah
country: United States
facility: Best Quality Research, Inc
state: Florida
city: Hialeah
country: United States
facility: United Research Institute LLC
state: Florida
city: Hollywood
country: United States
facility: Encore Medical Research. LLC
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Comprehensive Cancer Center(Drug shipment)-Research Pharmacy
state: Florida
city: Miami
country: United States
facility: Medical Professional Clinical Research Center, Inc.
state: Florida
city: Miami
country: United States
facility: Blessed Health Care & Research, Inc
state: Florida
city: Miami
country: United States
facility: Advance Research Center
state: Florida
city: New Port Richey
country: United States
facility: Alliance Clinical Research of Tampa, LLC
state: Florida
city: Orlando
country: United States
facility: Digestive and Liver Center of Florida, LLC
state: Florida
city: Orlando
country: United States
facility: Clinical Research of Osceola
state: Florida
city: Tampa
country: United States
facility: USF Health Morsani Center for Advanced Healthcare
state: Florida
city: Weston
country: United States
facility: Encore Medical Research of Weston, LLC
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C.
state: Georgia
city: Snellville
country: United States
facility: EBGS Clinical Research Center
state: Georgia
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC.
state: Michigan
city: Wyoming
country: United States
facility: Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center.
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 (Clinic Visits)
state: Mississippi
city: Weldon Spring
country: United States
facility: St Charles Clinical Research
state: Missouri
city: Freehold
country: United States
facility: Tandem - Allied Clinical Research, LLC
state: New Jersey
city: Brooklyn
country: United States
facility: N.Y. Total Medical Care, PC
state: New York
city: Manhasset
country: United States
facility: Lenox Hill Hospital
state: New York
city: New York
country: United States
facility: NYU Grossman School of Medicne
state: New York
city: Greenville
country: United States
facility: Carolina Research
state: North Carolina
city: Statesville
country: United States
facility: Piedmont Healthcare
state: North Carolina
city: Beavercreek
country: United States
facility: Dayton Gastroenterology, LLC
state: Ohio
city: Cincinnati
country: United States
facility: Gastro Health Research
state: Ohio
city: Lima
country: United States
facility: NexGen Research
state: Ohio
city: Westlake
country: United States
facility: Gastro Intestinal Research Institute of Northern Ohio, LLC
state: Ohio
city: Hershey
country: United States
facility: Penn State University Milton S. Hershey Medical Center
state: Pennsylvania
city: Pottsville
country: United States
facility: Care Access - Pottsville
state: Pennsylvania
city: Jackson
country: United States
facility: Skyline gastroenterology of west Tennessee
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Inflammatory Bowel Disease Clinic
state: Tennessee
city: Fredericksburg
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: Georgetown
country: United States
facility: Amel Med Llc
state: Texas
city: Houston
country: United States
facility: Southwest Clinical Trials
state: Texas
city: Mansfield
country: United States
facility: GI Alliance - Mansfield
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC
state: Texas
city: San Antonio
country: United States
facility: Southern Star Research Institute, LLC.
state: Texas
city: Tyler
country: United States
facility: Tyler Research Institute, LLC.
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Medical Center
state: Virginia
city: Lansdowne Town Center
country: United States
facility: Emeritas Research Group
state: Virginia
city: Roanoke
country: United States
facility: Gastroenterology Consultants of Southwest Virginia
state: Virginia
city: Sydney
country: Australia
facility: Macquarie University
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Adult Hospital - Mater Misericordiae Ltd and Mater Research Ltd
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital - Metro South Health
state: Queensland
city: Woodville
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Health - Monash Medical Centre
state: Victoria
city: Epping
country: Australia
facility: Northern Hospital - Northern Health
state: Victoria
city: Fitzroy
country: Australia
facility: Saint Vincent's Hospital Melbourne
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital - Westerm Health
state: Victoria
city: Innsbruck
country: Austria
facility: Medical University Innsbruck, University Hospital for Internal Medicine I
city: Vienna
country: Austria
facility: Medical University Vienna, Department of Internal Medicine Division Gastroenterology and Hepatology
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Vaughan
country: Canada
facility: TDDA Specialty Reserach
city: Slany
country: Czechia
facility: Nemocnice Slany
city: La Tronche
country: France
facility: Centre Hospitalier Universitaire Grenoble Alpes(CHUGA) - Service Hepato-Gastroentérologie, 7éme unité D
city: Nantes
country: France
facility: CHU Nantes Gastroenterology department
city: Pierre-Benite
country: France
facility: Hospices Civilis de Lyon - Hospital Lyon Sud Department of Gastroenterology
city: Tbilisi
country: Georgia
facility: ARENSIA Exploratory Medicine
city: Kiel
country: Germany
facility: University Hospital Schleswig-Holstein, Clinic for Internal Medicine
city: Ulm
country: Germany
facility: Ulm University Hospital, Centre for Internal Medicine I
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Általanos Orvostudományi Kar
city: Budapest
country: Hungary
facility: Clinexpert Gyógycentrum
city: Bologna
country: Italy
facility: Azienda Ospedaliero-Universitaria Di Bologna IRCCS
city: Catanzaro
country: Italy
facility: AOU "Renato Dulbecco" - Digestive Physiopathology Unit
city: Milano
country: Italy
facility: San Raffaele Hospital IRCCS
city: Palermo
country: Italy
facility: AOOR Villa Sofia- Cervello
city: Roma
country: Italy
facility: Campus Biomedico University Hospital Foundation
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital IRB
city: Daegu
country: Korea, Republic of
facility: Kyungpook National University Hospital
city: Daejeon
country: Korea, Republic of
facility: The Catholic University of Korea Daejeon St.Mary's Hospital
city: Guri-Si
country: Korea, Republic of
facility: Kyung Hee University Hospital
city: Jongno-Gu
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Nam-Gu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seongdong-gu
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul St. Mary's Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea
city: Wonju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Johor Bahru
country: Malaysia
facility: Hospital Sultanah Aminah
city: Kelantan
country: Malaysia
facility: Hospital Universiti Sains Malaysia
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Kuantan
country: Malaysia
facility: Hospital Tengku Ampuan Afzan
city: Kuantan
country: Malaysia
facility: Sultan Ahmad Shah Medical Centre @IIUM
city: Petaling Jaya
country: Malaysia
facility: University Malaya Medical Centre
city: Selangor
country: Malaysia
facility: Hospital Sultan Idris Shah Serdang
city: Chisinau
country: Moldova, Republic of
facility: PMSI Clinical Republican Hospital "Timofei Molneaga"
city: Katowice
country: Poland
facility: NZOZ Holsamed - Oddzial Libero
city: Kraków
country: Poland
facility: Endoskopia Sp. z.o.o.
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o.
city: Ksawerów
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
city: Lublin
country: Poland
facility: Medrise Sp. z o.o.
city: Mazowieckie
country: Poland
facility: Centrum Innowacyjnych Terapii Sp. z o.o.
city: Poznan
country: Poland
facility: Gabinety Lekarskie RIVERMED
city: Poznań
country: Poland
facility: EMC Instytut Medyczny SA PL Certus Szpital Nr 1 PL Certus Ambulatorium
city: Rzeszów
country: Poland
facility: Centrum Medyczne Medyk Sp. z 0.0. sp.k.
city: Szczecin
country: Poland
facility: Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. zo.o.
city: Torun
country: Poland
facility: Gastromed Sp. z.o.o.
city: Tychy
country: Poland
facility: H-T Centrum Medyczne - Endoterapia
city: Warsaw
country: Poland
facility: Przychodnia care Access Warsawa
city: Warsaw
country: Poland
facility: Medical Network Sp. z 0.0. WIP Warsaw IBD Point Profesor Kierkus
city: Warszawa
country: Poland
facility: Bodyclinic Sp. z o.o. sp.k.
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz
city: Wroclaw
country: Poland
facility: FutureMeds Wrocław
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Wrocław
country: Poland
facility: Przychodnia Euromedicare szpital euromedicare
city: Bucharest
country: Romania
facility: Centrul Medical Monza S.R.L
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina
city: București
country: Romania
facility: Institutul Clinic Fundeni
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean De Urgenta Cluj-Napoca
city: Satu Mare
country: Romania
facility: Spitalul Judetean de Urgenta Satu Mare
city: Timisoara
country: Romania
facility: Centrul De Gastroenterologie Dr. Goldis S.R.L
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide. Complejo Hospitalario Universitario de Ferrol
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramon Jimenez
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Changhua City
country: Taiwan
facility: Changhua Christian Hospital
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Medical University Chung-Ho Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, 7, Chung-Shan South Road, Taipei, ZIP 100
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Taoyuan City
country: Taiwan
facility: Chang Gung Memorial Hospital (CGMH)
city: Bristol
country: United Kingdom
facility: Southmead Hospital - North Bristol Trust Clinical Research Centre
city: Bury
country: United Kingdom
facility: Fairfield General Hospital, Northerncare Alliance NHS Foundation Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Trust, Addenbrookes Hospital
city: Cardiff
country: United Kingdom
facility: Synexus Clinical Research Centre
city: Hexham
country: United Kingdom
facility: Synexus North East Clinical Research Centre
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: