NCT05156125

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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Clinical Efficacy and Safety of VTX002 in Subjects With Moderately to Severely Active Ulcerative Colitis

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Oppilan Pharma Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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 189 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 Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of VTX002 in subjects with moderately to severely active UC following daily oral administration of VTX002 as a tablet. Approximately 189 eligible subjects will be randomized in a 1:1:1 ratio to receive VTX002 Dose A, VTX002 Dose B, or matching placebo, once daily (approximately 63 subjects per treatment group). The study consists of a 28-day Screening Period, a 13-week double-blind Induction Treatment Period (including 7 days of titration followed by 12 weeks of treatment at the assigned dose), a Long-Term Extension (LTE) Treatment Period of up to 39 weeks, an Open-Label Extension (OLE) Treatment Period of up to 143 weeks, and a 2-week Follow-Up Period. The maximal duration of treatment including the Induction Period, LTE and OLE will be 36 months. Objectives Primary Objective • Assess the efficacy of VTX002 when administered for 13 weeks on clinical remission Secondary Objectives * Assess the efficacy of VTX002 when administered for 13 weeks on endoscopic changes, symptomatic response and remission, histology, and mucosal healing * Assess the safety and tolerability of VTX002 * Assess the pharmacokinetics (PK) of VTX002 Long-Term and Open-Label Extension Objectives * Assess the efficacy of VTX002 through the LTE and OLE Treatment Periods on endoscopic changes, symptomatic response and remission, histology, and mucosal healing * Assess the safety of VTX002 through the LTE and OLE Treatment Periods

Conditions

• Colitis, Ulcerative

Interventions

Type	Name	Description
DRUG	VTX002	Dose A tablet administered orally once daily
DRUG	VTX002	Dose B Tablet administered orally once daily
DRUG	Placebo	Placebo Tablet for VTX002 administered orally once daily

Timeline

• Start date: 2021-11-30
• Primary completion: 2023-08-30
• Completion: 2026-08-31
• First posted: 2021-12-14
• Last updated: 2024-11-13
• Results posted: 2024-11-13

Locations

77 sites across 14 countries: United States, Bulgaria, Czechia, France, Georgia, Germany, Hungary, India, Italy, Lithuania, Poland, Serbia, Slovakia, South Korea

Regulatory

• FDA-regulated drug study