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

Primary Purpose

Ulcerative Colitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
GB004
Placebo
Sponsored by
GB004, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring Inflammatory Bowel Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent 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) 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:

  • Prior approved biologic therapy used for the treatment of UC.
  • 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.

NOTE: Other Inclusion/Exclusion criteria may apply per protocol.

Sites / Locations

  • B G Clinical Research, Inc.
  • Gastro Care Institute
  • Texas Digestive Disease Consultants
  • Gastroenterology Clinic of Acadiana
  • Delta Research Partners
  • Huron Gastroenterology Associates
  • Mayo Clinic
  • Las Vegas Medical Research
  • Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County
  • Great Lakes Gastroenterology Research, LLC
  • Texas Digestive Disease Consultant
  • Washington Gastroenterology, PLLC
  • Washington Gastroenterology, PLCC
  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
  • LTD Aversi Clinic
  • LTD Central University Clinic After Academic N. Kipshidze
  • LTD Coloproctological Center of Georgia
  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
  • Inje University Heaundae Paik Hospital
  • Dong-A University Hospital
  • Kyungpook National University Chilgok Hospital
  • PMSI Republican Clinical Hospital "Timofei Mosneaga"
  • CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska
  • St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine
  • Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA
  • Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice
  • "LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices
  • Medicome Limited Liability Company, Oswiecim Clinical Trial Centre
  • Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]
  • "NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK
  • "Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]
  • EB GROUP Limited Liability Company, MDM Health Centre
  • WIP Warsaw IBD Point Profesor Kierkus
  • Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center
  • VIVAMED Non-Public Healthcare Facility
  • Clinical Research Center Piotr Napora Medical Doctors Professional Partnership
  • Colentina Clinical Hospital
  • Limited Liability Company Joint Venture Diagnostic Center "Biotherm"
  • "Myod" Ltd.
  • Federal Siberian Research Clinical Center under the Federal Medical Biological Agency
  • Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department
  • Medical Center SibNovoMed, Limited Liability Company
  • Novosibirskiy Gastrocenter, LLC
  • Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
  • Medical Diagnostic Center, Limited Liability Company
  • Penza Regional Clinical Hospital named after N.N. Burdenko
  • Clinic UZI 4D, Limited Liability Company
  • S.M. Kirov Miltiary Medical Academy
  • St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38
  • Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs
  • Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital
  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab
  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje''
  • Clinical Hospital Center Zemun
  • Zvezdara University Medical Center-local lab
  • Clinical Center Kragujevac
  • General Hospital "Djordje Joanovic"
  • Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
  • Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519
  • Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527
  • Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
  • PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council
  • Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"
  • PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council
  • Medical Center of the Limited Liability Company "Harmoniia Krasy"
  • Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
  • Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"
  • Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"
  • The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council
  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
  • Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
  • Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"
  • MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"
  • Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1
  • PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"
  • MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council
  • Limited Liability Company "Medibor"

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

PCP Placebo

PCP GB004 480 mg QD

PCP GB004 480 mg BID

Open-Label Extension (OLE) GB004 480 mg BID

Arm Description

PCP Placebo for oral administration for 36 weeks

PCP GB004 480 mg QD for oral administration for 36 weeks

PCP GB004 480 mg BID for oral administration for 36 weeks

OLE GB004 480 mg BID for oral administration for 24 weeks

Outcomes

Primary Outcome Measures

Percentage of Participants With Clinical Remission at PCP Week 12
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Percentage of Participants With a Treatment Emergent Adverse Event
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs. An AE was considered treatment-emergent to the OLE if it started on or after the first dose of OLE study treatment.

Secondary Outcome Measures

Percentage of Participants With Clinical Response at PCP Week 12
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Percentage of Participants With Histologic Remission at PCP Week 12
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. Histologic remission is evaluated among subjects with both baseline lamina propria neutrophils and neutrophils in epithelium RHI subscores > 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Percentage of Participants With Endoscopic Improvement at PCP Week 12
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Percentage of Participants With Mucosal Healing at PCP Week 12
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 12 and for Percentage of Participants With Histologic Remission at PCP Week 12 for information on the measures of endoscopic improvement and histologic remission, respectively.
Percentage of Participants With Clinical Remission at PCP Week 36
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Percentage of Participants With Clinical Response at PCP Week 36
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Percentage of Participants With Histologic Remission at PCP Week 36
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Percentage of Participants With Endoscopic Improvement at PCP Week 36
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Percentage of Participants With Mucosal Healing at PCP Week 36
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 36 and for Percentage of Participants With Histologic Remission at PCP Week 36 for information on the measures of endoscopic improvement and histologic remission, respectively.

Full Information

First Posted
September 15, 2020
Last Updated
July 27, 2023
Sponsor
GB004, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04556383
Brief Title
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
Official Title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multi-center Study to Evaluate GB004 in Adult Subjects With Mild-to-moderate Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Terminated
Why Stopped
Study terminated due to lack of treatment benefit.
Study Start Date
October 19, 2020 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GB004, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
Inflammatory Bowel Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Subjects, investigators and site personnel, and the Sponsor will be blinded to individual subject treatment assignments.
Allocation
Randomized
Enrollment
236 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCP Placebo
Arm Type
Placebo Comparator
Arm Description
PCP Placebo for oral administration for 36 weeks
Arm Title
PCP GB004 480 mg QD
Arm Type
Experimental
Arm Description
PCP GB004 480 mg QD for oral administration for 36 weeks
Arm Title
PCP GB004 480 mg BID
Arm Type
Experimental
Arm Description
PCP GB004 480 mg BID for oral administration for 36 weeks
Arm Title
Open-Label Extension (OLE) GB004 480 mg BID
Arm Type
Experimental
Arm Description
OLE GB004 480 mg BID for oral administration for 24 weeks
Intervention Type
Drug
Intervention Name(s)
GB004
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Percentage of Participants With Clinical Remission at PCP Week 12
Description
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Time Frame
At PCP Week 12
Title
Percentage of Participants With a Treatment Emergent Adverse Event
Description
An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to study treatment. Abnormal laboratory test results or other safety assessments, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator were to be reported as AEs. An AE was considered treatment-emergent to the OLE if it started on or after the first dose of OLE study treatment.
Time Frame
From first dose of OLE study treatment through OLE Week 28
Secondary Outcome Measure Information:
Title
Percentage of Participants With Clinical Response at PCP Week 12
Description
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Time Frame
At PCP Week 12
Title
Percentage of Participants With Histologic Remission at PCP Week 12
Description
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. Histologic remission is evaluated among subjects with both baseline lamina propria neutrophils and neutrophils in epithelium RHI subscores > 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Time Frame
At PCP Week 12
Title
Percentage of Participants With Endoscopic Improvement at PCP Week 12
Description
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Time Frame
At PCP Week 12
Title
Percentage of Participants With Mucosal Healing at PCP Week 12
Description
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 12 and for Percentage of Participants With Histologic Remission at PCP Week 12 for information on the measures of endoscopic improvement and histologic remission, respectively.
Time Frame
At PCP Week 12
Title
Percentage of Participants With Clinical Remission at PCP Week 36
Description
Clinical remission is defined as a Modified Mayo score ≤ 2, with a rectal bleeding subscore of 0, stool frequency subscore of 0 or 1 (with a ≥ 1 point decrease from baseline), and endoscopic subscore of 0 or 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Time Frame
At PCP Week 36
Title
Percentage of Participants With Clinical Response at PCP Week 36
Description
Clinical response is defined as a reduction in Modified Mayo score of ≥ 2 points and ≥ 35% from baseline, including a decrease in rectal bleeding subscore of ≥ 1 or absolute rectal bleeding subscore of ≤ 1. The Modified Mayo score is an endpoint measure composed of: Stool frequency, Rectal bleeding, and Endoscopic subscores (where the Endoscopic subscore value of 1 does not include friability), each ranging from 0 to 3, that are summed to give a total score ranging from 0 to 9 points, with higher scores indicating greater severity.
Time Frame
At PCP Week 36
Title
Percentage of Participants With Histologic Remission at PCP Week 36
Description
Histologic remission is defined as Robarts Histopathology Index (RHI) ≤ 3 with lamina propria neutrophils RHI subscore = 0 and neutrophils in epithelium RHI subscore = 0. The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.
Time Frame
At PCP Week 36
Title
Percentage of Participants With Endoscopic Improvement at PCP Week 36
Description
Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. The endoscopic subscore is a component of the Modified Mayo score and is assessed on a 0-3 scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, absent vascular pattern, friability, erosions); and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate greater endoscopic disease severity. An endoscopic subscore of 1 does not include friability; an endoscopy with friability is assessed an endoscopic subscore of at least 2.
Time Frame
At PCP Week 36
Title
Percentage of Participants With Mucosal Healing at PCP Week 36
Description
Mucosal healing is defined as endoscopic improvement and histologic remission. Please see Secondary Outcome Measure Descriptions above for Percentage of Participants With Endoscopic Improvement at PCP Week 36 and for Percentage of Participants With Histologic Remission at PCP Week 36 for information on the measures of endoscopic improvement and histologic remission, respectively.
Time Frame
At PCP Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult male and female subjects aged ≥ 18 years at the time of signing the informed consent 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) 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: prednisone ≤ 20 mg/day or equivalent or beclomethasone ≤ 5 mg/day or budesonide or budesonide multi-matrix (MMX) of ≤ 9 mg/day Exclusion Criteria: Prior approved biologic therapy used for the treatment of UC. 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. NOTE: Other Inclusion/Exclusion criteria may apply per protocol.
Facility Information:
Facility Name
B G Clinical Research, Inc.
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Gastro Care Institute
City
Lancaster
State/Province
California
ZIP/Postal Code
93534
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Gastroenterology Clinic of Acadiana
City
Lafayette
State/Province
Louisiana
ZIP/Postal Code
70503
Country
United States
Facility Name
Delta Research Partners
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Huron Gastroenterology Associates
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Las Vegas Medical Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89113
Country
United States
Facility Name
Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Texas Digestive Disease Consultant
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Washington Gastroenterology, PLLC
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Washington Gastroenterology, PLCC
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Aversi Clinic
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Central University Clinic After Academic N. Kipshidze
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
LTD Coloproctological Center of Georgia
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD
City
Tbilisi
ZIP/Postal Code
0172
Country
Georgia
Facility Name
Inje University Heaundae Paik Hospital
City
Busan
ZIP/Postal Code
48018
Country
Korea, Republic of
Facility Name
Dong-A University Hospital
City
Busan
ZIP/Postal Code
49201
Country
Korea, Republic of
Facility Name
Kyungpook National University Chilgok Hospital
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
PMSI Republican Clinical Hospital "Timofei Mosneaga"
City
Chisinau
ZIP/Postal Code
MD2025
Country
Moldova, Republic of
Facility Name
CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska
City
Bydgoszcz
ZIP/Postal Code
85-794
Country
Poland
Facility Name
St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine
City
Elblag
ZIP/Postal Code
82-300
Country
Poland
Facility Name
Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA
City
Jelenia Gora
ZIP/Postal Code
58-500
Country
Poland
Facility Name
Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice
City
Katowice
ZIP/Postal Code
40-752
Country
Poland
Facility Name
"LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices
City
Krakow
ZIP/Postal Code
31-156
Country
Poland
Facility Name
Medicome Limited Liability Company, Oswiecim Clinical Trial Centre
City
Oswiecim
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Marek Horynski, MD, Ph.D. Individual Specialist Medical Practice [Specjialistyczna Praktyka Lekarska Dr med. Marek Horynski]
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
"NOWE ZDROWIE-CK" Kieltucki and Partners General Partnership, NOWE ZDROWIE-CK
City
Staszow
ZIP/Postal Code
28-200
Country
Poland
Facility Name
"Gastromed" Torun Gastrology Centre [Torunskie Centrum Gastrologiczne "Gastromed"]
City
Toruń
ZIP/Postal Code
87-100
Country
Poland
Facility Name
EB GROUP Limited Liability Company, MDM Health Centre
City
Warsaw
ZIP/Postal Code
00-635
Country
Poland
Facility Name
WIP Warsaw IBD Point Profesor Kierkus
City
Warsaw
ZIP/Postal Code
00-728
Country
Poland
Facility Name
Reuma Park Clinic Limited Liability Company Limited Partnership, Reuma Park Medical Center
City
Warsaw
ZIP/Postal Code
02-665
Country
Poland
Facility Name
VIVAMED Non-Public Healthcare Facility
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Clinical Research Center Piotr Napora Medical Doctors Professional Partnership
City
Wroclaw
ZIP/Postal Code
51-162
Country
Poland
Facility Name
Colentina Clinical Hospital
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
Limited Liability Company Joint Venture Diagnostic Center "Biotherm"
City
Barnaul
ZIP/Postal Code
656015
Country
Russian Federation
Facility Name
"Myod" Ltd.
City
Bataysk
ZIP/Postal Code
346880
Country
Russian Federation
Facility Name
Federal Siberian Research Clinical Center under the Federal Medical Biological Agency
City
Krasnoyarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
Moscow State-Funded Healthcare Institution City Clinical Hospital n.a. V.M. Buyanov under Moscow Healthcare Department
City
Moscow
ZIP/Postal Code
115516
Country
Russian Federation
Facility Name
Medical Center SibNovoMed, Limited Liability Company
City
Novosibirsk
ZIP/Postal Code
630005
Country
Russian Federation
Facility Name
Novosibirskiy Gastrocenter, LLC
City
Novosibirsk
ZIP/Postal Code
630007
Country
Russian Federation
Facility Name
Institute of Cytology and Genetics, Siberian Branch of the Russian Academy of Sciences
City
Novosibirsk
ZIP/Postal Code
630089
Country
Russian Federation
Facility Name
Medical Diagnostic Center, Limited Liability Company
City
Orenburg
ZIP/Postal Code
460051
Country
Russian Federation
Facility Name
Penza Regional Clinical Hospital named after N.N. Burdenko
City
Penza
ZIP/Postal Code
440026
Country
Russian Federation
Facility Name
Clinic UZI 4D, Limited Liability Company
City
Pyatigorsk
ZIP/Postal Code
357502
Country
Russian Federation
Facility Name
S.M. Kirov Miltiary Medical Academy
City
St Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
St. Petersburg State-Funded Healthcare Institution: City Outpatient Care Unit No. 38
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Consultation and Diagnostics Center and Outpatient Care Unit under the Department of Presidential Affairs
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital
City
Veliky Novgorod
ZIP/Postal Code
173008
Country
Russian Federation
Facility Name
Clinical Hospital Center "Dr Dragisa Misovic Dedinje'' local lab
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center "Dr Dragisa Misovic Dedinje''
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Hospital Center Zemun
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Zvezdara University Medical Center-local lab
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Facility Name
Clinical Center Kragujevac
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Facility Name
General Hospital "Djordje Joanovic"
City
Zrenjanin
ZIP/Postal Code
23000
Country
Serbia
Facility Name
Communal Nonprofit Enterprise "Cherkasy Regional Hospital of Cherkasy Oblast Council"
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Facility Name
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9519
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Regional Communal Noncommercial Enterprise "Chernivtsi Regional Clinical Hospital" Site 9527
City
Chernivtsi
ZIP/Postal Code
58001
Country
Ukraine
Facility Name
Public Non-Profit Enterprise "Regional Clinical Hospital under Ivano-Frankivsk Regional Council"
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
PNPE "Prof. O.O. Shalimov City Clinical Hospital #2" under Kharkiv City Council
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Public Non-Profit Enterprise under Kharkiv Regional Council "Regional Clinical Hospital"
City
Kharkiv
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
PNPE "Kyiv City Clinical Hospital #18" under the Executive Body of Kyiv City Council
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Medical Center of the Limited Liability Company "Harmoniia Krasy"
City
Kyiv
ZIP/Postal Code
01135
Country
Ukraine
Facility Name
Medical Center "OK!Clinic+" of the Company with Limited Liability "International Institute of Clinical Research"
City
Kyiv
ZIP/Postal Code
02091
Country
Ukraine
Facility Name
Medical Center of the Limited Liability Company "Medical Center "CONSILIUM MEDICAL"
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Public Non-Profit Enterprise under Kyiv Regional Council "Kyiv Regional Hospital"
City
Kyiv
ZIP/Postal Code
04078
Country
Ukraine
Facility Name
The Municipal Enterprise "Volyn Regional Clinical Hospital" of the Volyn Regional Council
City
Lutsk
ZIP/Postal Code
43005
Country
Ukraine
Facility Name
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Hospital"
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Public Non-Profit Enterprise "Odesa Regional Clinical Hospital" under Odesa Regional Council
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Public Enterprise "Poltava M.V. Sklifosovsky Regional Clinical Hospital under Poltava Regional Council"
City
Poltava
ZIP/Postal Code
36011
Country
Ukraine
Facility Name
MNPE "Vinnytsia Regional Clinical Hospital named after M.I. Pirogov Vinnytsia Regional Council"
City
Vinnytsia
ZIP/Postal Code
21028
Country
Ukraine
Facility Name
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital #1
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
PNPE "City Hospital of Urgent and Emergency Medical Care under Zaporizhia City Council"
City
Zaporizhia
ZIP/Postal Code
69005
Country
Ukraine
Facility Name
MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council
City
Zaporizhia
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Limited Liability Company "Medibor"
City
Zhytomyr
ZIP/Postal Code
10002
Country
Ukraine

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35014040
Citation
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.
Results Reference
derived

Learn more about this trial

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

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