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

Phase 2
Waitlist Available
Research Sponsored by GB004, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at pcp week 36

Summary

This trial is testing a new medication called GB004 to see if it helps people with ulcerative colitis when added to their current treatments. The study focuses on patients already using standard therapies. GB004 aims to reduce gut inflammation and improve their condition.

Eligible Conditions
  • Colitis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at pcp week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and at pcp week 36 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of Participants With Clinical Remission at PCP Week 12
Percentage of Participants With a Treatment Emergent Adverse Event
Secondary study objectives
Percentage of Participants With Clinical Remission at PCP Week 36
Percentage of Participants With Clinical Response at PCP Week 12
Percentage of Participants With Clinical Response at PCP Week 36
+6 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: PCP GB004 480 mg QDExperimental Treatment1 Intervention
PCP GB004 480 mg QD for oral administration for 36 weeks
Group II: PCP GB004 480 mg BIDExperimental Treatment1 Intervention
PCP GB004 480 mg BID for oral administration for 36 weeks
Group III: Open-Label Extension (OLE) GB004 480 mg BIDExperimental Treatment1 Intervention
OLE GB004 480 mg BID for oral administration for 24 weeks
Group IV: PCP PlaceboPlacebo Group1 Intervention
PCP Placebo for oral administration for 36 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GB004
2019
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

GB004, Inc.Lead Sponsor
Barrett Levesque, MDStudy DirectorGossamer Bio Inc.
~46 spots leftby Dec 2025
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