A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)

Last updated: July 27, 2023
Sponsor: GB004, Inc.
Overall Status: Terminated

Phase

2

Condition

Inflammatory Bowel Disease

Ulcerative Colitis

Ulcers

Treatment

Placebo

GB004

Clinical Study ID

NCT04556383
GB004-2101
2020-002306-12
  • Ages > 18
  • All Genders

Study Summary

A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of 5-aminosalicylate (5-ASA) with or without systemic steroids.

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:
  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

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

Total Participants: 236
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
October 19, 2020
Estimated Completion Date:
June 01, 2022

Connect with a study center

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales 2200
    Australia

    Site Not Available

  • Coral Sea Clinical Research Institute

    North Mackay, Queensland 4740
    Australia

    Site Not Available

  • University of the Sunshine Coast Clinical Trials Centre

    Sippy Downs, Queensland 4556
    Australia

    Site Not Available

  • Royal Adelaide Hospital

    Adelaide, South Australia 5000
    Australia

    Site Not Available

  • Gastroenterology Department, Lyell McEwin Hospital

    Elizabeth Vale, South Australia 5112
    Australia

    Site Not Available

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0160
    Georgia

    Site Not Available

  • LTD Aversi Clinic

    Tbilisi, 0160
    Georgia

    Site Not Available

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160
    Georgia

    Site Not Available

  • LTD Coloproctological Center of Georgia

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

    Tbilisi, 0172
    Georgia

    Site Not Available

  • Dong-A University Hospital

    Busan, 49201
    Korea, Republic of

    Site Not Available

  • Inje University Heaundae Paik Hospital

    Busan, 48018
    Korea, Republic of

    Site Not Available

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404
    Korea, Republic of

    Site Not Available

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    Seoul, 06591
    Korea, Republic of

    Site Not Available

  • PMSI Republican Clinical Hospital "Timofei Mosneaga"

    Chisinau, MD2025
    Moldova, Republic of

    Site Not Available

  • CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska

    Bydgoszcz, 85-794
    Poland

    Site Not Available

  • St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine

    Elblag, 82-300
    Poland

    Site Not Available

  • Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA

    Jelenia Gora, 58-500
    Poland

    Site Not Available

  • Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice

    Katowice, 40-752
    Poland

    Site Not Available

  • "LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices

    Krakow, 31-156
    Poland

    Site Not Available

  • Medicome Limited Liability Company, Oswiecim Clinical Trial Centre

    Oswiecim, 32-600
    Poland

    Site Not Available

  • Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]

    Sopot, 81-756
    Poland

    Site Not Available

  • "NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK

    Staszow, 28-200
    Poland

    Site Not Available

  • "Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]

    Toruń, 87-100
    Poland

    Site Not Available

  • EB GROUP Limited Liability Company, MDM Health Centre

    Warsaw, 00-635
    Poland

    Site Not Available

  • Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center

    Warsaw, 02-665
    Poland

    Site Not Available

  • VIVAMED Non-Public Healthcare Facility

    Warsaw, 03-580
    Poland

    Site Not Available

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728
    Poland

    Site Not Available

  • Clinical Research Center Piotr Napora Medical Doctors Professional Partnership

    Wroclaw, 51-162
    Poland

    Site Not Available

  • Colentina Clinical Hospital

    Bucharest, 020125
    Romania

    Site Not Available

  • Gastromedica SRL

    Iaşi, 700506
    Romania

    Site Not Available

  • Limited Liability Company Joint Venture Diagnostic Center "Biotherm"

    Barnaul, 656015
    Russian Federation

    Site Not Available

  • "Myod" Ltd.

    Bataysk, 346880
    Russian Federation

    Site Not Available

  • Chita State Medical Academy under the Ministry of Healthcare of the Russian Federation

    Chita, 672000
    Russian Federation

    Site Not Available

  • Belyayev Regional Clinical Hospital of the Kuzbass

    Kemerovo, 650066
    Russian Federation

    Site Not Available

  • Federal Siberian Research Clinical Center under the Federal Medical Biological Agency

    Krasnoyarsk, 660037
    Russian Federation

    Site Not Available

  • Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department

    Moscow, 115516
    Russian Federation

    Site Not Available

  • Private Healthcare Institution: RZD Medicine Nizhniy Novgorod Clinical Hospital

    Nizhniy Novgorod, 603140
    Russian Federation

    Site Not Available

  • Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences

    Novosibirsk, 630089
    Russian Federation

    Site Not Available

  • Medical Center SibNovoMed, Limited Liability Company

    Novosibirsk, 630005
    Russian Federation

    Site Not Available

  • Novosibirskiy Gastrocenter, LLC

    Novosibirsk, 630007
    Russian Federation

    Site Not Available

  • Medical Diagnostic Center, Limited Liability Company

    Orenburg, 460051
    Russian Federation

    Site Not Available

  • Penza Regional Clinical Hospital named after N.N. Burdenko

    Penza, 440026
    Russian Federation

    Site Not Available

  • Clinic UZI 4D, Limited Liability Company

    Pyatigorsk, 357502
    Russian Federation

    Site Not Available

  • S.M. Kirov Miltiary Medical Academy

    St Petersburg, 191015
    Russian Federation

    Site Not Available

  • Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs

    St. Petersburg, 197110
    Russian Federation

    Site Not Available

  • St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38

    St. Petersburg, 191015
    Russian Federation

    Site Not Available

  • Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital

    Veliky Novgorod, 173008
    Russian Federation

    Site Not Available

  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje''

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Hospital Center Zemun

    Belgrade, 11000
    Serbia

    Site Not Available

  • Zvezdara University Medical Center-local lab

    Belgrade, 11000
    Serbia

    Site Not Available

  • Clinical Center Kragujevac

    Kragujevac, 34000
    Serbia

    Site Not Available

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000
    Serbia

    Site Not Available

  • Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519

    Chernivtsi, 58001
    Ukraine

    Site Not Available

  • Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527

    Chernivtsi, 58001
    Ukraine

    Site Not Available

  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"

    Ivano-Frankivsk, 76008
    Ukraine

    Site Not Available

  • PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"

    Kharkiv, 61058
    Ukraine

    Site Not Available

  • Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"

    Kyiv, 02091
    Ukraine

    Site Not Available

  • Medical Center of the Limited Liability Company "Harmoniia Krasy"

    Kyiv, 01135
    Ukraine

    Site Not Available

  • Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"

    Kyiv, 04050
    Ukraine

    Site Not Available

  • PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council

    Kyiv, 01030
    Ukraine

    Site Not Available

  • Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"

    Kyiv, 04078
    Ukraine

    Site Not Available

  • The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council

    Lutsk, 43005
    Ukraine

    Site Not Available

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"

    Lviv, 79010
    Ukraine

    Site Not Available

  • Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council

    Odesa, 65025
    Ukraine

    Site Not Available

  • Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"

    Poltava, 36011
    Ukraine

    Site Not Available

  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1

    Vinnytsia, 21029
    Ukraine

    Site Not Available

  • MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"

    Vinnytsia, 21028
    Ukraine

    Site Not Available

  • MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council

    Zaporizhia, 69600
    Ukraine

    Site Not Available

  • PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"

    Zaporizhia, 69005
    Ukraine

    Site Not Available

  • Limited Liability Company "Medibor"

    Zhytomyr, 10002
    Ukraine

    Site Not Available

  • Gastro SB Clinic

    Chula Vista, California 91910
    United States

    Site Not Available

  • B G Clinical Research, Inc.

    Encinitas, California 92024
    United States

    Site Not Available

  • Gastro Care Institute

    Lancaster, California 93534
    United States

    Site Not Available

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana 70809
    United States

    Site Not Available

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana 70503
    United States

    Site Not Available

  • Delta Research Partners

    Monroe, Louisiana 71201
    United States

    Site Not Available

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Las Vegas Medical Research

    Las Vegas, Nevada 89113
    United States

    Site Not Available

  • Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County

    Freehold, New Jersey 07728
    United States

    Site Not Available

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio 44060
    United States

    Site Not Available

  • Susquehanna Research Group, LLC

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Texas Digestive Disease Consultant

    Southlake, Texas 76092
    United States

    Site Not Available

  • Washington Gastroenterology, PLLC

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Washington Gastroenterology, PLCC

    Tacoma, Washington 98405
    United States

    Site Not Available

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