Phase
Condition
Inflammatory Bowel Disease
Ulcerative Colitis
Ulcers
Treatment
Placebo
GB004
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Adult male and female subjects aged ≥ 18 years at the time of signing the informedconsent form (ICF) prior to initiation of any study specific activities/procedures.
- UC diagnosed at least 3 months prior to first dose of investigational product (IP) onDay 1.
- Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior toflexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine)alone or with one of the following oral treatments:
- prednisone ≤ 20 mg/day or equivalent or
- beclomethasone ≤ 5 mg/day or
- budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day
Exclusion
Exclusion Criteria:
- Prior approved biologic therapy used for the treatment of UC.
- Diagnosis of Crohn's disease, indeterminate colitis, or pouchitis, or presence ofbacterial or parasitic infection.
- Tofacitinib, oral cyclosporine, sirolimus or mycophenolate mofetil within 8 weeks ofDay 1.
- Azathioprine, or 6-mercaptopurine within 1 day of Day 1. NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Study Design
Connect with a study center
Bankstown-Lidcombe Hospital
Bankstown, New South Wales 2200
AustraliaSite Not Available
Coral Sea Clinical Research Institute
North Mackay, Queensland 4740
AustraliaSite Not Available
University of the Sunshine Coast Clinical Trials Centre
Sippy Downs, Queensland 4556
AustraliaSite Not Available
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaSite Not Available
Gastroenterology Department, Lyell McEwin Hospital
Elizabeth Vale, South Australia 5112
AustraliaSite Not Available
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
Tbilisi, 0160
GeorgiaSite Not Available
LTD Aversi Clinic
Tbilisi, 0160
GeorgiaSite Not Available
LTD Central University Clinic After Academic N. Kipshidze
Tbilisi, 0160
GeorgiaSite Not Available
LTD Coloproctological Center of Georgia
Tbilisi, 0160
GeorgiaSite Not Available
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
Tbilisi, 0172
GeorgiaSite Not Available
Dong-A University Hospital
Busan, 49201
Korea, Republic ofSite Not Available
Inje University Heaundae Paik Hospital
Busan, 48018
Korea, Republic ofSite Not Available
Kyungpook National University Chilgok Hospital
Daegu, 41404
Korea, Republic ofSite Not Available
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Korea, Republic ofSite Not Available
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, MD2025
Moldova, Republic ofSite Not Available
CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska
Bydgoszcz, 85-794
PolandSite Not Available
St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine
Elblag, 82-300
PolandSite Not Available
Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA
Jelenia Gora, 58-500
PolandSite Not Available
Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice
Katowice, 40-752
PolandSite Not Available
"LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices
Krakow, 31-156
PolandSite Not Available
Medicome Limited Liability Company, Oswiecim Clinical Trial Centre
Oswiecim, 32-600
PolandSite Not Available
Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]
Sopot, 81-756
PolandSite Not Available
"NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK
Staszow, 28-200
PolandSite Not Available
"Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]
Toruń, 87-100
PolandSite Not Available
EB GROUP Limited Liability Company, MDM Health Centre
Warsaw, 00-635
PolandSite Not Available
Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center
Warsaw, 02-665
PolandSite Not Available
VIVAMED Non-Public Healthcare Facility
Warsaw, 03-580
PolandSite Not Available
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728
PolandSite Not Available
Clinical Research Center Piotr Napora Medical Doctors Professional Partnership
Wroclaw, 51-162
PolandSite Not Available
Colentina Clinical Hospital
Bucharest, 020125
RomaniaSite Not Available
Gastromedica SRL
Iaşi, 700506
RomaniaSite Not Available
Limited Liability Company Joint Venture Diagnostic Center "Biotherm"
Barnaul, 656015
Russian FederationSite Not Available
"Myod" Ltd.
Bataysk, 346880
Russian FederationSite Not Available
Chita State Medical Academy under the Ministry of Healthcare of the Russian Federation
Chita, 672000
Russian FederationSite Not Available
Belyayev Regional Clinical Hospital of the Kuzbass
Kemerovo, 650066
Russian FederationSite Not Available
Federal Siberian Research Clinical Center under the Federal Medical Biological Agency
Krasnoyarsk, 660037
Russian FederationSite Not Available
Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department
Moscow, 115516
Russian FederationSite Not Available
Private Healthcare Institution: RZD Medicine Nizhniy Novgorod Clinical Hospital
Nizhniy Novgorod, 603140
Russian FederationSite Not Available
Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
Novosibirsk, 630089
Russian FederationSite Not Available
Medical Center SibNovoMed, Limited Liability Company
Novosibirsk, 630005
Russian FederationSite Not Available
Novosibirskiy Gastrocenter, LLC
Novosibirsk, 630007
Russian FederationSite Not Available
Medical Diagnostic Center, Limited Liability Company
Orenburg, 460051
Russian FederationSite Not Available
Penza Regional Clinical Hospital named after N.N. Burdenko
Penza, 440026
Russian FederationSite Not Available
Clinic UZI 4D, Limited Liability Company
Pyatigorsk, 357502
Russian FederationSite Not Available
S.M. Kirov Miltiary Medical Academy
St Petersburg, 191015
Russian FederationSite Not Available
Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs
St. Petersburg, 197110
Russian FederationSite Not Available
St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38
St. Petersburg, 191015
Russian FederationSite Not Available
Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital
Veliky Novgorod, 173008
Russian FederationSite Not Available
Clinical Hospital Center "Dr Dragisa Misovic Dedinje''
Belgrade, 11000
SerbiaSite Not Available
Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab
Belgrade, 11000
SerbiaSite Not Available
Clinical Hospital Center Zemun
Belgrade, 11000
SerbiaSite Not Available
Zvezdara University Medical Center-local lab
Belgrade, 11000
SerbiaSite Not Available
Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
General Hospital "Djordje Joanovic"
Zrenjanin, 23000
SerbiaSite Not Available
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
Cherkasy, 18009
UkraineSite Not Available
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519
Chernivtsi, 58001
UkraineSite Not Available
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527
Chernivtsi, 58001
UkraineSite Not Available
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, 76008
UkraineSite Not Available
PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council
Kharkiv, 61037
UkraineSite Not Available
Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"
Kharkiv, 61058
UkraineSite Not Available
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
Kyiv, 02091
UkraineSite Not Available
Medical Center of the Limited Liability Company "Harmoniia Krasy"
Kyiv, 01135
UkraineSite Not Available
Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"
Kyiv, 04050
UkraineSite Not Available
PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council
Kyiv, 01030
UkraineSite Not Available
Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"
Kyiv, 04078
UkraineSite Not Available
The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council
Lutsk, 43005
UkraineSite Not Available
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
Lviv, 79010
UkraineSite Not Available
Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
Odesa, 65025
UkraineSite Not Available
Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"
Poltava, 36011
UkraineSite Not Available
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1
Vinnytsia, 21029
UkraineSite Not Available
MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"
Vinnytsia, 21028
UkraineSite Not Available
MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council
Zaporizhia, 69600
UkraineSite Not Available
PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"
Zaporizhia, 69005
UkraineSite Not Available
Limited Liability Company "Medibor"
Zhytomyr, 10002
UkraineSite Not Available
Gastro SB Clinic
Chula Vista, California 91910
United StatesSite Not Available
B G Clinical Research, Inc.
Encinitas, California 92024
United StatesSite Not Available
Gastro Care Institute
Lancaster, California 93534
United StatesSite Not Available
Texas Digestive Disease Consultants
Baton Rouge, Louisiana 70809
United StatesSite Not Available
Gastroenterology Clinic of Acadiana
Lafayette, Louisiana 70503
United StatesSite Not Available
Delta Research Partners
Monroe, Louisiana 71201
United StatesSite Not Available
Huron Gastroenterology Associates
Ypsilanti, Michigan 48197
United StatesSite Not Available
Mayo Clinic
Rochester, Minnesota 55905
United StatesSite Not Available
Las Vegas Medical Research
Las Vegas, Nevada 89113
United StatesSite Not Available
Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County
Freehold, New Jersey 07728
United StatesSite Not Available
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio 44060
United StatesSite Not Available
Susquehanna Research Group, LLC
Harrisburg, Pennsylvania 17110
United StatesSite Not Available
Texas Digestive Disease Consultant
Southlake, Texas 76092
United StatesSite Not Available
Washington Gastroenterology, PLLC
Bellevue, Washington 98004
United StatesSite Not Available
Washington Gastroenterology, PLCC
Tacoma, Washington 98405
United StatesSite Not Available

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