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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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.

Key facts

Study ID

NCT04556383

Run by

GB004, Inc.

People needed

236

Starts

2020-10-19

Expected to finish

2022-06-01

Last updated by the study team

2023-08-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Gastro Care Institute — Lancaster, California, United States
• Texas Digestive Disease Consultants — Baton Rouge, Louisiana, United States
• Gastroenterology Clinic of Acadiana — Lafayette, Louisiana, United States
• Delta Research Partners — Monroe, Louisiana, United States
• Huron Gastroenterology Associates — Ypsilanti, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Las Vegas Medical Research — Las Vegas, Nevada, United States
• Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County — Freehold, New Jersey, United States
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States
• Texas Digestive Disease Consultant — Southlake, Texas, United States
• Washington Gastroenterology, PLLC — Bellevue, Washington, United States
• Washington Gastroenterology, PLCC — Tacoma, Washington, United States
• JSC Infectious Diseases, AIDS and Clinical Immunology Research Center — Tbilisi, Georgia
• LTD Aversi Clinic — Tbilisi, Georgia
• LTD Central University Clinic After Academic N. Kipshidze — Tbilisi, Georgia
• LTD Coloproctological Center of Georgia — Tbilisi, Georgia
• Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LTD — Tbilisi, Georgia
• PMSI Republican Clinical Hospital "Timofei Mosneaga" — Chisinau, Moldova
• CLINSANTE Clinical Research Center Civil Law Partnership Ewa Galczak-Nowak, Malgorzata Trzaska — Bydgoszcz, Poland
• St. John Paul 2 Municipal Hospital in Elblag, Department of Internal Medicine — Elblag, Poland
• Clinical Research Center of Karkonosze - Lexmedica Limited Liability Company, KCBK - LEXMEDICA — Jelenia Góra, Poland
• Professor K. Gibinski University Clinical Centre of the Medical University of Silesia in Katowice — Katowice, Poland
• "LANDA" Katarzyna Agata Landa, Landa" Specialist Doctor's Offices — Krakow, Poland
• Medicome Limited Liability Company, Oswiecim Clinical Trial Centre — Oświęcim, Poland
• B G Clinical Research, Inc. — Encinitas, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.