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

April 9, 2026 updated by: Oppilan Pharma Ltd

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

213

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Rousse, Bulgaria
        • Local Site # 100002
      • Rousse, Bulgaria
        • Local Site # 100005
  • Czechia
      • Hradec Králové, Czechia
        • Local Site # 203002
      • Slaný, Czechia
        • Local Site # 203001
      • Ústí nad Labem, Czechia
        • Local Site # 203004
  • France
      • Caen, France
        • Local Site # 250004
      • Nantes, France
        • Local Site # 250001
      • Vandœuvre-lès-Nancy, France
        • Local Site # 250003
  • Georgia
      • Tbilisi, Georgia
        • Local Site # 268001
      • Tbilisi, Georgia
        • Local Site # 268002
      • Tbilisi, Georgia
        • Local Site # 268003
      • Tbilisi, Georgia
        • Local Site # 268004
      • Tbilisi, Georgia
        • Local Site # 268005
      • Tbilisi, Georgia
        • Local Site # 268006
  • Germany
      • Berlin, Germany
        • Local Site # 276005
      • Brandenburg an der Havel, Germany
        • Local Site # 276008
      • Duisburg, Germany
        • Local Site # 276007
      • Halle, Germany
        • Local Site # 276009
      • Nordhausen, Germany
        • Local Site # 276003
  • Hungary
      • Budapest, Hungary
        • Local Site # 348001
      • Budapest, Hungary
        • Local Site # 348003
      • Békéscsaba, Hungary
        • Local Site # 348004
      • Székesfehérvár, Hungary
        • Local Site # 348002
  • India
      • Ahmedabad, India
        • Local Site # 356001
      • Jaipur, India
        • Local Site # 356003
      • Sūrat, India
        • Local Site # 356005
  • Italy
      • Milan, Italy
        • Local Site # 380009
      • Negrar, Italy
        • Local Site # 380001
      • Pavia, Italy
        • Local Site # 380004
      • Rome, Italy
        • Local Site # 380008
      • San Giovanni Rotondo, Italy
        • Local Site # 380002
  • Lithuania
      • Panevezys, Lithuania
        • Local Site # 440002
      • Vilnius, Lithuania
        • Local Site # 440001
  • Poland
      • Bydgoszcz, Poland
        • Local Site # 616010
      • Jelenia Góra, Poland
        • Local Site # 616012
      • Lodz, Poland
        • Local Site # 616001
      • Lodz, Poland
        • Local Site # 616017
      • Lublin, Poland
        • Local Site # 616015
      • Oświęcim, Poland
        • Local Site # 616004
      • Piotrkow Trybunalski, Poland
        • Local Site # 616011
      • Poznan, Poland
        • Local Site # 616008
      • Rzeszów, Poland
        • Local Site # 616014
      • Sosnowiec, Poland
        • Local Site # 616007
      • Warsaw, Poland
        • Local Site # 616003
      • Warsaw, Poland
        • Local Site # 616006
      • Wroclaw, Poland
        • Local Site # 616002
      • Wroclaw, Poland
        • Local Site # 616009
      • Wroclaw, Poland
        • Local Site # 616013
  • Serbia
      • Belgrade, Serbia
        • Local Site # 688002
      • Belgrade, Serbia
        • Local Site # 688003
      • Belgrade, Serbia
        • Local Site # 688004
      • Zrenjanin, Serbia
        • Local Site # 688001
  • Slovakia
      • Košice, Slovakia
        • Local Site # 703001
      • Prešov, Slovakia
        • Local Site # 703003
      • Šahy, Slovakia
        • Local Site # 703002
  • South Korea
      • Daegu, South Korea
        • Local Site # 410003
      • Seoul, South Korea
        • Local Site # 410002
      • Wŏnju, South Korea
        • Local Site # 410004
  • United States
    • California
      • Garden Grove, California, United States, 92845
        • Local Site # 840030
      • Lancaster, California, United States, 93534
        • Local Site # 840026
      • San Diego, California, United States, 92123
        • Local Site # 840040
      • Ventura, California, United States, 93003
        • Local Site # 840001
    • Florida
      • Kissimmee, Florida, United States, 34744
        • Local Site # 840049
      • Miami, Florida, United States, 33165
        • Local Site # 840006
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Local Site # 840018
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Local Site # 840046
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Local Site # 840042
    • Michigan
      • Ypsilanti, Michigan, United States, 48197
        • Local Site # 840044
    • Ohio
      • Dayton, Ohio, United States, 45415
        • Local Site # 840043
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73101
        • Local Site # 840010
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Local Site # 840045
    • Texas
      • Garland, Texas, United States, 75044
        • Local Site # 840013
      • Lubbock, Texas, United States, 79424
        • Local Site # 8400039
      • McAllen, Texas, United States, 78503
        • Local Site # 840033
      • San Marcos, Texas, United States, 78666
        • Local Site # 840007
      • Southlake, Texas, United States, 76092
        • Local Site # 840016
      • Tyler, Texas, United States, 75701
        • Local Site # 840028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VTX002 Dose A
VTX002 Dose A tablet administered orally once daily
Drug: VTX002
Dose A tablet administered orally once daily
Other Names:
  • OPL-002
Drug: VTX002
Dose B Tablet administered orally once daily
Other Names:
  • OPL-002
Experimental: VTX002 Dose B
VTX002 Dose B tablet administered orally once daily
Drug: VTX002
Dose A tablet administered orally once daily
Other Names:
  • OPL-002
Drug: VTX002
Dose B Tablet administered orally once daily
Other Names:
  • OPL-002
Placebo Comparator: Placebo
Placebo tablet administered orally once daily
Drug: Placebo
Placebo Tablet for VTX002 administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Remission at 13 Weeks
Time Frame: Day 1 of Induction treatment period to Week 13
The percentage of participants with clinical remission at Week 13. Clinical remission was based on the modified Mayo score (MMS), which is a composite score of participant-reported symptoms and endoscopies which were assessed by a central reader. Clinical remission was defined as stool frequency (SF) subscore = 0 or 1, rectal bleeding (RB) subscore = 0, and endoscopic subscore (ES) ≤ 1 (excluding friability). Each component subscore ranged from 0 to 3 and total score range of the MMS was from 0 to 9, with higher scores indicating more severe disease.
Day 1 of Induction treatment period to Week 13

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endoscopic Improvement at Week 13
Time Frame: Day 1 of Induction Treatment Period to Week 13
The percentage of participants with endoscopic improvement at Week 13. Endoscopic improvement was assessed from endoscopies assessed by a central reader. Endoscopic improvement was defined as ES ≤ 1 (excluding friability). The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease).
Day 1 of Induction Treatment Period to Week 13
Symptomatic Remission at Week 13
Time Frame: Day 1 of Induction Treatment Period to Week 13
The percentage of participants with symptomatic remission at Week 13. Symptomatic remission was measured using participant-reported symptoms and was defined as SF subscore = 0 or 1 and RB subscore = 0. The SF subscore ranged from 0 to 3 (where 0 = normal number of stools and 3 = at least 5 stools more than normal) and RB subscore ranged from 0 to 3 (where 0 = no blood and 3 = blood alone passes). Higher scores indicate more severe disease.
Day 1 of Induction Treatment Period to Week 13
Histologic Remission at Week 13
Time Frame: Day 1 of Induction Treatment Period to Week 13
The percentage of participants with histologic remission at Week 13. Histologic remission was assessed using the Geboes Index score and defined for this outcome measure as a Geboes score < 2.0. The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
Day 1 of Induction Treatment Period to Week 13
Endoscopic Improvement-Histologic Remission at Week 13
Time Frame: Day 1 of Induction Treatment Period to Week 13
The percentage of participants with endoscopic improvement-histologic remission at Week 13. This outcome measure was assessed by endoscopic histologic scores and defined as ES ≤ 1 (excluding friability) and a Geboes Index score < 2.0. The ES ranged from 0 to 3 (where 0 = normal/inactive disease and 3 = severe disease). The Geboes score grading system is a validated score for evaluating histologic disease activity in ulcerative colitis and is graded on a scale of 0 to 5. A higher Geboes score indicates more severe disease.
Day 1 of Induction Treatment Period to Week 13
PK of VTX002
Time Frame: Weeks 1, 4, 8, and 13 of the Induction Treatment Period
Plasma concentrations of VTX002 in samples obtained predose at Weeks 1, 4, 8, and 13 in the Induction Treatment Period
Weeks 1, 4, 8, and 13 of the Induction Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oppilan Pharma Ltd

Investigators

  • Study Director: Snehal Naik, PhD, Ventyx Biosciences, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 30, 2021

Primary Completion (Actual)

August 30, 2023

Study Completion (Actual)

March 13, 2025

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 1, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VTX002-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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