A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
NCT ID: NCT04556383
Last Updated: 2023-08-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
236 participants
INTERVENTIONAL
2020-10-19
2022-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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PCP Placebo
PCP Placebo for oral administration for 36 weeks
Placebo
oral tablet
PCP GB004 480 mg QD
PCP GB004 480 mg QD for oral administration for 36 weeks
GB004
oral tablet
PCP GB004 480 mg BID
PCP GB004 480 mg BID for oral administration for 36 weeks
GB004
oral tablet
Open-Label Extension (OLE) GB004 480 mg BID
OLE GB004 480 mg BID for oral administration for 24 weeks
GB004
oral tablet
Interventions
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GB004
oral tablet
Placebo
oral tablet
Eligibility Criteria
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Inclusion Criteria
* UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
* Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following oral treatments:
1. prednisone ≤ 20 mg/day or equivalent or
2. beclomethasone ≤ 5 mg/day or
3. budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day
Exclusion Criteria
* Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence of bacterial or parasitic infection.
* Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks of Day 1.
* Azathioprine, or 6-mercaptopurine within 1 day of Day 1.
18 Years
ALL
No
Sponsors
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GB004, Inc.
INDUSTRY
Responsible Party
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Locations
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B G Clinical Research, Inc.
Encinitas, California, United States
Gastro Care Institute
Lancaster, California, United States
Texas Digestive Disease Consultants
Baton Rouge, Louisiana, United States
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana, United States
Delta Research Partners
Monroe, Louisiana, United States
Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County
Freehold, New Jersey, United States
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States
Texas Digestive Disease Consultant
Southlake, Texas, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, United States
Washington Gastroenterology, PLCC
Tacoma, Washington, United States
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, , Georgia
LTD Aversi Clinic
Tbilisi, , Georgia
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, , Georgia
LTD Coloproctological Center of Georgia
Tbilisi, , Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
Tbilisi, , Georgia
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, , Moldova
CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, , Poland
St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine
Elblag, , Poland
Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA
Jelenia Góra, , Poland
Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice
Katowice, , Poland
"LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices
Krakow, , Poland
Medicome Limited Liability Company, Oswiecim Clinical Trial Centre
Oświęcim, , Poland
Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]
Sopot, , Poland
"NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK
Staszów, , Poland
"Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]
Torun, , Poland
EB GROUP Limited Liability Company, MDM Health Centre
Warsaw, , Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, , Poland
Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center
Warsaw, , Poland
VIVAMED Non-Public Healthcare Facility
Warsaw, , Poland
Clinical Research Center Piotr Napora Medical Doctors Professional Partnership
Wroclaw, , Poland
Colentina Clinical Hospital
Bucharest, , Romania
Limited Liability Company Joint Venture Diagnostic Center "Biotherm"
Barnaul, , Russia
"Myod" Ltd.
Bataysk, , Russia
Federal Siberian Research Clinical Center under the Federal Medical Biological Agency
Krasnoyarsk, , Russia
Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department
Moscow, , Russia
Medical Center SibNovoMed, Limited Liability Company
Novosibirsk, , Russia
Novosibirskiy Gastrocenter, LLC
Novosibirsk, , Russia
Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Novosibirsk, , Russia
Medical Diagnostic Center, Limited Liability Company
Orenburg, , Russia
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, , Russia
Clinic UZI 4D, Limited Liability Company
Pyatigorsk, , Russia
S.M. Kirov Miltiary Medical Academy
Saint Petersburg, , Russia
St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38
Saint Petersburg, , Russia
Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs
Saint Petersburg, , Russia
Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital
Veliky Novgorod, , Russia
Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab
Belgrade, , Serbia
Clinical Hospital Center "Dr Dragisa Misovic Dedinje''
Belgrade, , Serbia
Clinical Hospital Center Zemun
Belgrade, , Serbia
Zvezdara University Medical Center-local lab
Belgrade, , Serbia
Clinical Center Kragujevac
Kragujevac, , Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, , Serbia
Inje University Heaundae Paik Hospital
Busan, , South Korea
Dong-A University Hospital
Busan, , South Korea
Kyungpook National University Chilgok Hospital
Daegu, , South Korea
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
Cherkasy, , Ukraine
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519
Chernivtsi, , Ukraine
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527
Chernivtsi, , Ukraine
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, , Ukraine
PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council
Kharkiv, , Ukraine
Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"
Kharkiv, , Ukraine
PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council
Kyiv, , Ukraine
Medical Center of the Limited Liability Company "Harmoniia Krasy"
Kyiv, , Ukraine
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
Kyiv, , Ukraine
Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"
Kyiv, , Ukraine
Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"
Kyiv, , Ukraine
The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council
Lutsk, , Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, , Ukraine
Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
Odesa, , Ukraine
Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"
Poltava, , Ukraine
MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"
Vinnytsia, , Ukraine
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1
Vinnytsia, , Ukraine
PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"
Zaporizhia, , Ukraine
MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council
Zaporizhia, , Ukraine
Limited Liability Company "Medibor"
Zhytomyr, , Ukraine
Countries
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References
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Danese S, Levesque BG, Feagan BG, Jucov A, Bhandari BR, Pai RK, Taylor Meadows K, Kirby BJ, Bruey JM, Olson A, Osterhout R, Van Biene C, Ford J, Aranda R, Raghupathi K, Sandborn WJ. Randomised clinical trial: a phase 1b study of GB004, an oral HIF-1alpha stabiliser, for treatment of ulcerative colitis. Aliment Pharmacol Ther. 2022 Feb;55(4):401-411. doi: 10.1111/apt.16753. Epub 2022 Jan 10.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2020-002306-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GB004-2101
Identifier Type: -
Identifier Source: org_study_id
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