GB004 in Adult Subjects With Active Ulcerative Colitis

Completed · Phase 1 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

This is a Phase 1b, randomized, double-blind-, placebo-controlled, multi-center study to evaluate the safety, tolerability, and PK of GB004 in adult subjects with active ulcerative colitis. Target engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.

Key facts

Study ID

NCT03860896

Run by

GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

People needed

34

Starts

2019-04-24

Expected to finish

2019-12-17

Last updated by the study team

2020-01-14

Who can join

Age: 18 and older, up to 74. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.

You may not qualify if…

• Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
• Patients receiving biologic agents and experimental agents are excluded.

Where it is running

• Delta Research Partners — Monroe, Louisiana, United States
• Arensia Exploratory Medicine — Tbilisi, Georgia
• PMSI Republican Clinical Hospital "Timofei Mosneaga" — Chisinau, Moldova

Full record on ClinicalTrials.gov

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