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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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)
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
Secondary ID [1] 0 0
2020-002306-12
Secondary ID [2] 0 0
GB004-2101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Clinical Remission at PCP Week 12
Timepoint [1] 0 0
At PCP Week 12
Primary outcome [2] 0 0
Percentage of Participants With a Treatment Emergent Adverse Event
Timepoint [2] 0 0
From first dose of OLE study treatment through OLE Week 28
Secondary outcome [1] 0 0
Percentage of Participants With Clinical Response at PCP Week 12
Timepoint [1] 0 0
At PCP Week 12
Secondary outcome [2] 0 0
Percentage of Participants With Histologic Remission at PCP Week 12
Timepoint [2] 0 0
At PCP Week 12
Secondary outcome [3] 0 0
Percentage of Participants With Endoscopic Improvement at PCP Week 12
Timepoint [3] 0 0
At PCP Week 12
Secondary outcome [4] 0 0
Percentage of Participants With Mucosal Healing at PCP Week 12
Timepoint [4] 0 0
At PCP Week 12
Secondary outcome [5] 0 0
Percentage of Participants With Clinical Remission at PCP Week 36
Timepoint [5] 0 0
At PCP Week 36
Secondary outcome [6] 0 0
Percentage of Participants With Clinical Response at PCP Week 36
Timepoint [6] 0 0
At PCP Week 36
Secondary outcome [7] 0 0
Percentage of Participants With Histologic Remission at PCP Week 36
Timepoint [7] 0 0
At PCP Week 36
Secondary outcome [8] 0 0
Percentage of Participants With Endoscopic Improvement at PCP Week 36
Timepoint [8] 0 0
At PCP Week 36
Secondary outcome [9] 0 0
Percentage of Participants With Mucosal Healing at PCP Week 36
Timepoint [9] 0 0
At PCP Week 36

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/10/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2022
Sample size
Target
Accrual to date
Final
236
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Louisiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Michigan
Country [4] 0 0
United States of America
State/province [4] 0 0
Minnesota
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
Ohio
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Georgia
State/province [10] 0 0
Tbilisi
Country [11] 0 0
Korea, Republic of
State/province [11] 0 0
Busan
Country [12] 0 0
Korea, Republic of
State/province [12] 0 0
Daegu
Country [13] 0 0
Moldova, Republic of
State/province [13] 0 0
Chisinau
Country [14] 0 0
Poland
State/province [14] 0 0
Bydgoszcz
Country [15] 0 0
Poland
State/province [15] 0 0
Elblag
Country [16] 0 0
Poland
State/province [16] 0 0
Jelenia Gora
Country [17] 0 0
Poland
State/province [17] 0 0
Katowice
Country [18] 0 0
Poland
State/province [18] 0 0
Krakow
Country [19] 0 0
Poland
State/province [19] 0 0
Oswiecim
Country [20] 0 0
Poland
State/province [20] 0 0
Sopot
Country [21] 0 0
Poland
State/province [21] 0 0
Staszow
Country [22] 0 0
Poland
State/province [22] 0 0
Torun
Country [23] 0 0
Poland
State/province [23] 0 0
Warsaw
Country [24] 0 0
Poland
State/province [24] 0 0
Wroclaw
Country [25] 0 0
Romania
State/province [25] 0 0
Bucharest
Country [26] 0 0
Russian Federation
State/province [26] 0 0
Barnaul
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Bataysk
Country [28] 0 0
Russian Federation
State/province [28] 0 0
Krasnoyarsk
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Moscow
Country [30] 0 0
Russian Federation
State/province [30] 0 0
Novosibirsk
Country [31] 0 0
Russian Federation
State/province [31] 0 0
Orenburg
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Penza
Country [33] 0 0
Russian Federation
State/province [33] 0 0
Pyatigorsk
Country [34] 0 0
Russian Federation
State/province [34] 0 0
St Petersburg
Country [35] 0 0
Russian Federation
State/province [35] 0 0
St. Petersburg
Country [36] 0 0
Russian Federation
State/province [36] 0 0
Veliky Novgorod
Country [37] 0 0
Serbia
State/province [37] 0 0
Belgrade
Country [38] 0 0
Serbia
State/province [38] 0 0
Kragujevac
Country [39] 0 0
Serbia
State/province [39] 0 0
Zrenjanin
Country [40] 0 0
Ukraine
State/province [40] 0 0
Cherkasy
Country [41] 0 0
Ukraine
State/province [41] 0 0
Chernivtsi
Country [42] 0 0
Ukraine
State/province [42] 0 0
Ivano-Frankivsk
Country [43] 0 0
Ukraine
State/province [43] 0 0
Kharkiv
Country [44] 0 0
Ukraine
State/province [44] 0 0
Kyiv
Country [45] 0 0
Ukraine
State/province [45] 0 0
Lutsk
Country [46] 0 0
Ukraine
State/province [46] 0 0
Lviv
Country [47] 0 0
Ukraine
State/province [47] 0 0
Odesa
Country [48] 0 0
Ukraine
State/province [48] 0 0
Poltava
Country [49] 0 0
Ukraine
State/province [49] 0 0
Vinnytsia
Country [50] 0 0
Ukraine
State/province [50] 0 0
Zaporizhia
Country [51] 0 0
Ukraine
State/province [51] 0 0
Zhytomyr

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GB004, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04556383
Trial related presentations / publications
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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04556383