Overview

VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis

Status:
Recruiting

Trial end date:
2023-10-01

Target enrollment:
0

Participant gender:
All

Summary

This is a study to understand if taking VTX002 daily as a tablet orally is safe and effective in participants diagnosed with moderate to severe ulcerative colitis (UC). Approximately 180 participants will take VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily. The study consists of a 28-day Screening Period (to see if a participant qualifies for the study), a 13-week double-blind period (a participant receives either active Dose A, Dose B or Placebo), a 39-week OLE Treatment Period (all participants receive active treatment) and a 2-week Follow-Up Period

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Oppilan Pharma Ltd

Criteria

Inclusion Criteria:

- Diagnosed with UC ≥ 3 months prior to Screening.

- Active UC confirmed by endoscopy

Exclusion Criteria:

- Severe extensive colitis

- Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history
of a fistula consistent with CD

- Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis