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

NCT04556383 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 236

Last updated 2023-08-01

Study results available
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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.

Conditions

Interventions

DRUG

GB004

oral tablet

DRUG

Placebo

oral tablet

Sponsors & Collaborators

  • GB004, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2022-06-01
Completion
2022-06-01
FDA Drug
Yes

Countries

  • United States
  • Georgia
  • Moldova
  • Poland
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04556383 on ClinicalTrials.gov