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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04556383
Registration number
NCT04556383
Ethics application status
Date submitted
15/09/2020
Date registered
21/09/2020
Date last updated
1/08/2023
Titles & IDs
Public title
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
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Scientific 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
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Secondary ID [1]
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2020-002306-12
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Secondary ID [2]
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GB004-2101
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis
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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Oral and Gastrointestinal
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Inflammatory bowel disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - GB004
Treatment: Drugs - Placebo
Placebo Comparator: PCP Placebo - PCP Placebo for oral administration for 36 weeks
Experimental: PCP GB004 480 mg QD - PCP GB004 480 mg QD for oral administration for 36 weeks
Experimental: PCP GB004 480 mg BID - PCP GB004 480 mg BID for oral administration for 36 weeks
Experimental: Open-Label Extension (OLE) GB004 480 mg BID - OLE GB004 480 mg BID for oral administration for 24 weeks
Treatment: Drugs: GB004
oral tablet
Treatment: Drugs: Placebo
oral tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Clinical Remission at PCP Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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At PCP Week 12
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Primary outcome [2]
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Percentage of Participants With a Treatment Emergent Adverse Event
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Assessment method [2]
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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.
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Timepoint [2]
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From first dose of OLE study treatment through OLE Week 28
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Secondary outcome [1]
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Percentage of Participants With Clinical Response at PCP Week 12
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Assessment method [1]
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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.
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Timepoint [1]
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At PCP Week 12
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Secondary outcome [2]
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Percentage of Participants With Histologic Remission at PCP Week 12
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Assessment method [2]
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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.
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Timepoint [2]
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At PCP Week 12
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Secondary outcome [3]
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Percentage of Participants With Endoscopic Improvement at PCP Week 12
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Assessment method [3]
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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.
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Timepoint [3]
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At PCP Week 12
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Secondary outcome [4]
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Percentage of Participants With Mucosal Healing at PCP Week 12
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Assessment method [4]
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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.
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Timepoint [4]
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At PCP Week 12
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Secondary outcome [5]
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Percentage of Participants With Clinical Remission at PCP Week 36
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Assessment method [5]
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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.
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Timepoint [5]
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At PCP Week 36
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Secondary outcome [6]
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Percentage of Participants With Clinical Response at PCP Week 36
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Assessment method [6]
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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.
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Timepoint [6]
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At PCP Week 36
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Secondary outcome [7]
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Percentage of Participants With Histologic Remission at PCP Week 36
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Assessment method [7]
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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.
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Timepoint [7]
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At PCP Week 36
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Secondary outcome [8]
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Percentage of Participants With Endoscopic Improvement at PCP Week 36
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Assessment method [8]
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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.
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Timepoint [8]
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At PCP Week 36
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Secondary outcome [9]
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Percentage of Participants With Mucosal Healing at PCP Week 36
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Assessment method [9]
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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.
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Timepoint [9]
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At PCP Week 36
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
19/10/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/06/2022
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Sample size
Target
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Accrual to date
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Final
236
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
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United States of America
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California
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Louisiana
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Michigan
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Georgia
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Tbilisi
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Busan
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Daegu
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Chisinau
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Veliky Novgorod
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Zrenjanin
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Cherkasy
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Kharkiv
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Kyiv
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Lutsk
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Lviv
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Odesa
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Zaporizhia
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Ukraine
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Zhytomyr
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
GB004, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04556383
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Trial related presentations / publications
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Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed
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Contacts
Principal investigator
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04556383
Download to PDF