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NCT05156125 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Colitis, Ulcerative, sponsored by Oppilan Pharma.

Active
Registry status
Phase 2
Development phase
213
Enrollment target
20
Study locations

NCT05156125 is a Phase 2 study of Colitis, Ulcerative that is active but no longer recruiting, run by Oppilan Pharma. The registered enrollment target is 213 participants, below the 398-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 11 states.

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The verdict

NCT05156125, a Phase 2 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Oppilan Pharma.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
213 participants
Enrollment target
20
Study locations

Study 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 Studied

Colitis, Ulcerative

Interventions

  • DRUG Placebo
  • DRUG VTX002

Study Locations (20)

Texas

  • Local Site # 840013 - Garland
  • Local Site # 8400039 - Lubbock
  • Local Site # 840033 - McAllen
  • Local Site # 840007 - San Marcos
  • Local Site # 840016 - Southlake
  • Local Site # 840028 - Tyler

California

  • Local Site # 840030 - Garden Grove
  • Local Site # 840026 - Lancaster
  • Local Site # 840040 - San Diego
  • Local Site # 840001 - Ventura

Florida

  • Local Site # 840049 - Kissimmee
  • Local Site # 840006 - Miami

Georgia

  • Local Site # 840018 - Atlanta

Indiana

  • Local Site # 840046 - New Albany

Louisiana

  • Local Site # 840042 - Shreveport

Michigan

  • Local Site # 840044 - Ypsilanti

Ohio

  • Local Site # 840043 - Dayton

Trial Details

FieldValue
Enrollment Target 213 participants
Start Date 2021-11-30
Est. Completion 2026-08-31
Phase Phase 2

Sponsor

Oppilan Pharma

1 total trials

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What the Registry Record Tells You About NCT05156125

The ClinicalTrials.gov registry entry for NCT05156125 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 213 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 398-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (46% lower). The listed sponsor is Oppilan Pharma, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05156125 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT05156125 about?

NCT05156125 is a clinical study titled "VTX002 Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis". 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...

What is the current status of trial NCT05156125?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 213 participants. The study started on 2021-11-30. Estimated completion is 2026-08-31.

What conditions does trial NCT05156125 study?

This clinical trial studies the following conditions: Colitis, Ulcerative.

What interventions are being tested in trial NCT05156125?

The interventions under investigation include: Placebo (DRUG), VTX002 (DRUG).

Who is sponsoring clinical trial NCT05156125?

This trial is sponsored by Oppilan Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05156125 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.