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Ulcerative ColitisPhase 2NCT04556383

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

A Phase 2 study testing GB004 in people with Ulcerative Colitis, run by GB004, Inc. at 77 sites in 9 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis
What is being tested?
GB004
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
236 participants
Where
77 sitesin 9 countries
Study dates
19 Oct 2020to 1 Jun 2022
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

77 sites in 9 countries.

77 sites in 9 countries

Ukraine20 sites

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

    Cherkasy, 18009

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

    Chernivtsi, 58001

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

    Chernivtsi, 58001

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

    Ivano-Frankivsk, 76008

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

    Kharkiv, 61037

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

    Kharkiv, 61058

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

    Kyiv, 01030

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

    Kyiv, 01135

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

    Kyiv, 02091

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

    Kyiv, 04050

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

    Kyiv, 04078

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

    Lutsk, 43005

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

    Lviv, 79010

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

    Odesa, 65025

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

    Poltava, 36011

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

    Vinnytsia, 21028

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

    Vinnytsia, 21029

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

    Zaporizhia, 69005

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

    Zaporizhia, 69600

  • Limited Liability Company "Medibor"

    Zhytomyr, 10002

Other trials in Ukraine

Poland14 sites

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

    Bydgoszcz, 85-794

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

    Elblag, 82-300

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

    Jelenia Góra, 58-500

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

    Katowice, 40-752

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

    Krakow, 31-156

  • Medicome Limited Liability Company, Oswiecim Clinical Trial Centre

    Oświęcim, 32-600

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

    Sopot, 81-756

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

    Staszów, 28-200

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

    Torun, 87-100

  • EB GROUP Limited Liability Company, MDM Health Centre

    Warsaw, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

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

    Warsaw, 02-665

  • VIVAMED Non-Public Healthcare Facility

    Warsaw, 03-580

  • Clinical Research Center Piotr Napora Medical Doctors Professional Partnership

    Wroclaw, 51-162

Other trials in Poland

Russia14 sites

  • Limited Liability Company Joint Venture Diagnostic Center "Biotherm"

    Barnaul, 656015

  • "Myod" Ltd.

    Bataysk, 346880

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

    Krasnoyarsk, 660037

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

    Moscow, 115516

  • Medical Center SibNovoMed, Limited Liability Company

    Novosibirsk, 630005

  • Novosibirskiy Gastrocenter, LLC

    Novosibirsk, 630007

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

    Novosibirsk, 630089

  • Medical Diagnostic Center, Limited Liability Company

    Orenburg, 460051

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

    Penza, 440026

  • Clinic UZI 4D, Limited Liability Company

    Pyatigorsk, 357502

  • S.M. Kirov Miltiary Medical Academy

    Saint Petersburg, 191015

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

    Saint Petersburg, 191015

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

    Saint Petersburg, 197110

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

    Velikiy Novgorod, 173008

Other trials in Russia

United States13 sites

  • Texas Digestive Disease Consultants

    Baton Rouge, Louisiana, 70809

  • Washington Gastroenterology, PLLC

    Bellevue, Washington, 98004

  • B G Clinical Research, Inc.

    Encinitas, California, 92024

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

    Freehold, New Jersey, 07728

  • Gastroenterology Clinic of Acadiana

    Lafayette, Louisiana, 70503

  • Gastro Care Institute

    Lancaster, California, 93534

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • Delta Research Partners

    Monroe, Louisiana, 71201

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Texas Digestive Disease Consultant

    Southlake, Texas, 76092

  • Washington Gastroenterology, PLCC

    Tacoma, Washington, 98405

  • Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197

Other trials in United States

Serbia6 sites

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

    Belgrade, 11000

  • Clinical Hospital Center "Dr Dragisa Misovic Dedinje''

    Belgrade, 11000

  • Clinical Hospital Center Zemun

    Belgrade, 11000

  • Zvezdara University Medical Center-local lab

    Belgrade, 11000

  • Clinical Center Kragujevac

    Kragujevac, 34000

  • General Hospital "Djordje Joanovic"

    Zrenjanin, 23000

Other trials in Serbia

Georgia5 sites

  • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

    Tbilisi, 0160

  • LTD Aversi Clinic

    Tbilisi, 0160

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160

  • LTD Coloproctological Center of Georgia

    Tbilisi, 0160

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

    Tbilisi, 0172

Other trials in Georgia

South Korea3 sites

  • Inje University Heaundae Paik Hospital

    Busan, 48018

  • Dong-A University Hospital

    Busan, 49201

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

Other trials in South Korea

Moldova1 site

  • PMSI Republican Clinical Hospital "Timofei Mosneaga"

    Chisinau, MD2025

Other trials in Moldova

Romania1 site

  • Colentina Clinical Hospital

    Bucharest, 020125

Other trials in Romania

About this study

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

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.

Being tested
GB004, Placebo
Keywords
Inflammatory Bowel Disease
Medical subject headings
Colitis, Ulcerative, Inflammatory Bowel Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GB004Drug

    oral tablet

  • PlaceboDrug

    oral tablet

Study groups in NCT04556383
Study groupRoleWhat they receive
PCP PlaceboPlacebo comparatorPCP Placebo for oral administration for 36 weeks
Receives: Drug: Placebo
PCP GB004 480 mg QDExperimentalPCP GB004 480 mg QD for oral administration for 36 weeks
Receives: Drug: GB004
PCP GB004 480 mg BIDExperimentalPCP GB004 480 mg BID for oral administration for 36 weeks
Receives: Drug: GB004
Open-Label Extension (OLE) GB004 480 mg BIDExperimentalOLE GB004 480 mg BID for oral administration for 24 weeks
Receives: Drug: GB004

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: At PCP Week 12

  2. 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.

    Measured: From first dose of OLE study treatment through OLE Week 28

Secondary outcomes (9)

  1. 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.

    Measured: At PCP Week 12

  2. 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.

    Measured: At PCP Week 12

  3. 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.

    Measured: At PCP Week 12

  4. 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.

    Measured: At PCP Week 12

  5. 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.

    Measured: At PCP Week 36

  6. 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.

    Measured: At PCP Week 36

  7. 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.

    Measured: At PCP Week 36

  8. 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.

    Measured: At PCP Week 36

  9. 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.

    Measured: At PCP Week 36

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2020
  2. Study start19 Oct 2020
  3. Primary completion1 Jun 2022
  4. Study completion1 Jun 2022

Why it stopped: Study terminated due to lack of treatment benefit.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
236 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04556383
Sponsor's protocol ID
GB004-2101
Other IDs
2020-002306-12
Status last verified
Jul 2023
First submitted
15 Sep 2020
Last updated
1 Aug 2023
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35014040

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GB004 in people with Ulcerative Colitis, run by GB004, Inc. at 77 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 77 sites in Ukraine, Poland, Russia, United States, Serbia and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Clinical Remission at PCP Week 12 (time frame: At PCP Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04556383, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.

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