Status:
COMPLETED
GB004 in Adult Subjects With Active Ulcerative Colitis
Lead Sponsor:
GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-74 years
Phase:
PHASE1
Brief Summary
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 eng...
Detailed Description
The safety, tolerability, pharmacokinetics, and pharmacodynamics of GB004 will be explored in a Phase 1b randomized controlled trial in adults subjects with active ulcerative colitis (UC). Subjects wi...
Eligibility Criteria
Inclusion
- Patients aged 18-74, receiving therapy for active ulcerative colitis confirmed by Mayo Score assessment, and evidence of colonic inflammation.
Exclusion
- Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- Patients receiving biologic agents and experimental agents are excluded.
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2019
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03860896
Start Date
April 24 2019
End Date
December 17 2019
Last Update
January 14 2020
Active Locations (3)
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1
Delta Research Partners
Monroe, Louisiana, United States, 71201
2
Arensia Exploratory Medicine
Tbilisi, Georgia, 0112
3
PMSI Republican Clinical Hospital "Timofei Mosneaga"
Chisinau, Moldova, MD2025