GB004 in Adult Subjects With Active Ulcerative Colitis

Phase 1

Completed

• Conditions: Ulcerative Colitis
• Interventions: Drug: GB004; Drug: Placebo

• Registration Number: NCT03860896
• Lead Sponsor: GB004, Inc., a wholly owned subsidiary of Gossamer Bio, Inc.

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 engagement and effect of GB004 on pharmacodynamic biomarkers will be assessed.

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 will be evaluated based on incidence of AEs, laboratory parameters, GB004 serum and colonic tissue concentrations, and changes in the signs and symptoms of UC.

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-28
• Study First Posted: 2019-03-04
• Study Start: 2019-04-24
• Primary Completion: 2019-12-17
• Study Completion: 2019-12-17
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GB004	GB004	GB004 for oral administration daily
Placebo	Placebo	Placebo for oral administration daily

Primary Outcome Measures

Name	Time	Method
Incidence of treatment emergent adverse events	56 Days	To evaluate the safety and tolerability of GB004 for 56 days in terms of incidence of treatment emergent adverse events reported.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics: Time to Reach Maximum Concentration (Tmax) of GB004	Day 1 to Day 28
Pharmacokinetics: Maximum Concentration (Cmax) of GB004	Day 1 to Day 28
Pharmacokinetics: Area Under the Concentration Curve (AUC) of GB004	Day 1 to Day 28

Trial Locations

Locations (3)

Delta Research Partners; 🇺🇸 Monroe, Louisiana, United States

PMSI Republican Clinical Hospital "Timofei Mosneaga"; 🇲🇩 Chisinau, Moldova, Republic of

Arensia Exploratory Medicine; 🇬🇪 Tbilisi, Georgia