A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
Public ClinicalTrials.gov record NCT04556383. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04556383
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 236 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 19, 2020 (Actual)
- Primary completion
- Jun 1, 2022 (Actual)
- Completion
- Jun 1, 2022 (Actual)
- Last update posted
- Aug 1, 2023
2020 – 2022
United States locations
- U.S. sites
- 13
- U.S. states
- 9
- U.S. cities
- 13
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| B G Clinical Research, Inc. | Encinitas | California | 92024 | — |
| Gastro Care Institute | Lancaster | California | 93534 | — |
| Texas Digestive Disease Consultants | Baton Rouge | Louisiana | 70809 | — |
| Gastroenterology Clinic of Acadiana | Lafayette | Louisiana | 70503 | — |
| Delta Research Partners | Monroe | Louisiana | 71201 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Las Vegas Medical Research | Las Vegas | Nevada | 89113 | — |
| Freehold Endoscopy Associates, LLC d/b/a/ Endoscopy Center of Monmouth County | Freehold | New Jersey | 07728 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Texas Digestive Disease Consultant | Southlake | Texas | 76092 | — |
| Washington Gastroenterology, PLLC | Bellevue | Washington | 98004 | — |
| Washington Gastroenterology, PLCC | Tacoma | Washington | 98405 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 64 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04556383, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 1, 2023 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04556383 live on ClinicalTrials.gov.