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

NCT05156125 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2026-04-30

Study results available
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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.

Conditions

  • Colitis, Ulcerative

Interventions

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

Sponsors & Collaborators

  • Oppilan Pharma Ltd

    lead INDUSTRY

Principal Investigators

  • Snehal Naik, PhD · Ventyx Biosciences, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2023-08-30
Completion
2025-03-13
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • India
  • Italy
  • Lithuania
  • Poland
  • Serbia
  • Slovakia
  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05156125 on ClinicalTrials.gov