Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 2 study of Colitis, Ulcerative, sponsored by Oppilan Pharma.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
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
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 213 participants |
| Start Date | 2021-11-30 |
| Est. Completion | 2026-08-31 |
| Phase | Phase 2 |
What the registry record for NCT05156125 still lists
NCT05156125 is an interventional study that assigns participants to a tested intervention. The registered 213 participants enrollment target is mid-sized for trials with a published cap, below the 398-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (46% lower).
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 names 20 study sites across 11 states, led by 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.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05156125's enrollment target sits among peer trials
213 16th of 28 higher than 13 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
RECRUITING · Phase 2
-
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
RECRUITING · Phase 2
-
Pharmacologic Weight Loss as Adjunct Therapy for Ulcerative Colitis in Obese Patients
RECRUITING · Phase 2
-
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
RECRUITING · Phase 2
-
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
ACTIVE NOT RECRUITING · Phase 2
-
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06476886 · 213 participants · NA
Intensive Crisis Intervention
- NCT06544655 · 213 participants · Phase 1
A Study of BMS-986484 Alone and Combination Therapy in Participants With Advanced Solid Tumors
- NCT07186816 · 213 participants · NA
SUpport From PEeRs to Expand Access Study - Community
- NCT04030507 · 214 participants · NA
Screening Magnetic Resonance Imaging of the Brain in Patients With Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI