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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Colitis, Ulcerative

In brief

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.

Key facts

Study ID

NCT05156125

Run by

Oppilan Pharma Ltd

People needed

213

Starts

2021-11-30

Expected to finish

2025-03-13

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosed with UC ≥ 3 months prior to Screening.
• Active UC confirmed by endoscopy

You may not qualify if…

• 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

Where it is running

• Local Site # 840026 — Lancaster, California, United States
• Local Site # 840040 — San Diego, California, United States
• Local Site # 840001 — Ventura, California, United States
• Local Site # 840049 — Kissimmee, Florida, United States
• Local Site # 840006 — Miami, Florida, United States
• Local Site # 840018 — Atlanta, Georgia, United States
• Local Site # 840046 — New Albany, Indiana, United States
• Local Site # 840042 — Shreveport, Louisiana, United States
• Local Site # 840044 — Ypsilanti, Michigan, United States
• Local Site # 840043 — Dayton, Ohio, United States
• Local Site # 840010 — Oklahoma City, Oklahoma, United States
• Local Site # 840045 — Myrtle Beach, South Carolina, United States
• Local Site # 840013 — Garland, Texas, United States
• Local Site # 8400039 — Lubbock, Texas, United States
• Local Site # 840033 — McAllen, Texas, United States
• Local Site # 840007 — San Marcos, Texas, United States
• Local Site # 840016 — Southlake, Texas, United States
• Local Site # 840028 — Tyler, Texas, United States
• Local Site # 100002 — Rousse, Bulgaria
• Local Site # 100005 — Rousse, Bulgaria
• Local Site # 203002 — Hradec Králové, Czechia
• Local Site # 203001 — Slaný, Czechia
• Local Site # 203004 — Ústí nad Labem, Czechia
• Local Site # 250004 — Caen, France
• Local Site # 840030 — Garden Grove, California, United States

Full record on ClinicalTrials.gov

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