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

Study Purpose

A 2-part study, comprising of a 36-week placebo-controlled period and a 24-week open-label extension 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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: 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04556383
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

GB004, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Barrett Levesque, MD
Principal Investigator Affiliation Gossamer Bio Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Australia, Georgia, Moldova, Republic of, Poland, Russian Federation, Ukraine, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Arms & Interventions

Arms

Experimental: GB004 Dose A

GB004 dose A for oral administration for 36 weeks

Experimental: GB004 Dose B

GB004 dose B for oral administration for 36 weeks

Placebo Comparator: Placebo

Placebo for oral administration for 36 weeks

Experimental: Open-Label GB004 Dose A

GB004 dose A for oral administration for 24 weeks

Interventions

Drug: - GB004

GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer

Drug: - Placebo

Placebo

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Gastro SB Clinic, Chula Vista, California

Status

Recruiting

Address

Gastro SB Clinic

Chula Vista, California, 91910

Site Contact

Principal Investigator

ClinicalTrials@gossamerbio.com

1-866-668-4083

B G Clinical Research, Inc., Encinitas, California

Status

Recruiting

Address

B G Clinical Research, Inc.

Encinitas, California, 92024

Gastro Care Institute, Lancaster, California

Status

Recruiting

Address

Gastro Care Institute

Lancaster, California, 93534

Site Contact

Principal Investigator

ClinicalTrials@gossamerbio.com

1-866-668-4083

Texas Digestive Disease Consultants, Baton Rouge, Louisiana

Status

Recruiting

Address

Texas Digestive Disease Consultants

Baton Rouge, Louisiana, 70809

Gastroenterology Clinic of Acadiana, Lafayette, Louisiana

Status

Recruiting

Address

Gastroenterology Clinic of Acadiana

Lafayette, Louisiana, 70503

Delta Research Partners, Monroe, Louisiana

Status

Recruiting

Address

Delta Research Partners

Monroe, Louisiana, 71201

Site Contact

Principal Investigator

ClinicalTrials@gossamerbio.com

1-866-668-4083

Las Vegas Medical Research, Las Vegas, Nevada

Status

Recruiting

Address

Las Vegas Medical Research

Las Vegas, Nevada, 89113

Site Contact

Principal Investigator

ClinicalTrials@gossamerbio.com

1-866-668-4083

Freehold, New Jersey

Status

Recruiting

Address

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

Freehold, New Jersey, 07728

Mentor, Ohio

Status

Recruiting

Address

Great Lakes Gastroenterology Research, LLC

Mentor, Ohio, 44060

Susquehanna Research Group, LLC, Harrisburg, Pennsylvania

Status

Recruiting

Address

Susquehanna Research Group, LLC

Harrisburg, Pennsylvania, 17110

Texas Digestive Disease Consultant, Southlake, Texas

Status

Recruiting

Address

Texas Digestive Disease Consultant

Southlake, Texas, 76092

International Sites

Coral Sea Clinical Research Institute, North Mackay, Queensland, Australia

Status

Recruiting

Address

Coral Sea Clinical Research Institute

North Mackay, Queensland, 4740

Sippy Downs, Queensland, Australia

Status

Recruiting

Address

University of the Sunshine Coast Clinical Trials Centre

Sippy Downs, Queensland, 4556

Tbilisi, Georgia

Status

Recruiting

Address

JSC Infectious Diseases, AIDS and Clinical Immunology Research Center

Tbilisi, , 0160

LTD Aversi Clinic, Tbilisi, Georgia

Status

Recruiting

Address

LTD Aversi Clinic

Tbilisi, , 0160

Tbilisi, Georgia

Status

Recruiting

Address

LTD Central University Clinic After Academic N. Kipshidze

Tbilisi, , 0160

LTD Coloproctological Center of Georgia, Tbilisi, Georgia

Status

Recruiting

Address

LTD Coloproctological Center of Georgia

Tbilisi, , 0160

Tbilisi, Georgia

Status

Recruiting

Address

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD

Tbilisi, , 0172

Chisinau, Moldova, Republic of

Status

Recruiting

Address

PMSI Republican Clinical Hospital "Timofei Mosneaga"

Chisinau, , MD2025

Bydgoszcz, Poland

Status

Recruiting

Address

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

Bydgoszcz, , 85-794

Jelenia Gora, Poland

Status

Recruiting

Address

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

Jelenia Gora, , 58-500

Katowice, Poland

Status

Recruiting

Address

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

Katowice, , 40-752

Krakow, Poland

Status

Recruiting

Address

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

Krakow, , 31-156

Oswiecim, Poland

Status

Recruiting

Address

Medicome Limited Liability Company, Oswiecim Clinical Trial Centre

Oswiecim, , 32-600

Sopot, Poland

Status

Recruiting

Address

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

Sopot, , 81-756

Warsaw, Poland

Status

Recruiting

Address

EB GROUP Limited Liability Company, MDM Health Centre

Warsaw, , 00-635

WIP Warsaw IBD Point Profesor Kierkus, Warsaw, Poland

Status

Recruiting

Address

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, , 00-728

Warsaw, Poland

Status

Recruiting

Address

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

Warsaw, , 02-691

VIVAMED Non-Public Healthcare Facility, Warsaw, Poland

Status

Recruiting

Address

VIVAMED Non-Public Healthcare Facility

Warsaw, , 03-580

Wroclaw, Poland

Status

Recruiting

Address

Clinical Research Center Piotr Napora Medical Doctors Professional Partnership

Wroclaw, , 51-162

Barnaul, Russian Federation

Status

Recruiting

Address

Limited Liability Company Joint Venture Diagnostic Center "Biotherm"

Barnaul, , 656015

Moscow, Russian Federation

Status

Recruiting

Address

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

Moscow, , 115516

Nizhniy Novgorod, Russian Federation

Status

Recruiting

Address

Private Healthcare Institution: RZD Medicine Nizhniy Novgorod Clinical Hospital

Nizhniy Novgorod, , 603140

Novosibirsk, Russian Federation

Status

Recruiting

Address

Medical Center SibNovoMed, Limited Liability Company

Novosibirsk, , 630005

Novosibirskiy Gastrocenter, LLC, Novosibirsk, Russian Federation

Status

Recruiting

Address

Novosibirskiy Gastrocenter, LLC

Novosibirsk, , 630007

Orenburg, Russian Federation

Status

Recruiting

Address

Medical Diagnostic Center, Limited Liability Company

Orenburg, , 460051

St. Petersburg, Russian Federation

Status

Recruiting

Address

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

St. Petersburg, , 197110

Veliky Novgorod, Russian Federation

Status

Recruiting

Address

Regional State-Funded Healthcare Institution: Novgorod Regional Clinic Hospital

Veliky Novgorod, , 173008

Cherkasy, Ukraine

Status

Recruiting

Address

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

Cherkasy, , 18009

Kharkiv, Ukraine

Status

Recruiting

Address

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

Kharkiv, , 61037

Kyiv, Ukraine

Status

Recruiting

Address

Medical Center of the Limited Liability Company "Harmoniia Krasy"

Kyiv, , 01135

Kyiv, Ukraine

Status

Recruiting

Address

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

Kyiv, , 02091

Kyiv, Ukraine

Status

Recruiting

Address

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

Kyiv, , 04050

Kyiv, Ukraine

Status

Recruiting

Address

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

Kyiv, , 04078

Lutsk, Ukraine

Status

Recruiting

Address

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

Lutsk, , 43005

Lviv, Ukraine

Status

Recruiting

Address

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

Lviv, , 79010

Zaporizhia, Ukraine

Status

Recruiting

Address

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

Zaporizhia, , 69005

Zaporizhia, Ukraine

Status

Recruiting

Address

MNPE "Zaporizhia Regional Clinical Hospital" of Zaporizhia Regional Council

Zaporizhia, , 69600

Limited Liability Company "Medibor", Zhytomyr, Ukraine

Status

Recruiting

Address

Limited Liability Company "Medibor"

Zhytomyr, , 10002

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