GB004 in Adult Subjects With Active Ulcerative Colitis

Gossamer Bio

Status and phase: Completed; Phase 1

Conditions: Ulcerative Colitis

Treatments: Drug: GB004; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03860896

GB004-1101

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

GB004

Experimental group

Description:

GB004 for oral administration daily

Treatment:

Drug: GB004

Drug: GB004

Placebo

Placebo Comparator group

Description:

Placebo for oral administration daily

Treatment:

Drug: Placebo