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NCT05156125TerminatedPhase 2

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

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

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Terminated
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
213 (actual)
First submitted
1 Dec 2021
Start date
30 Nov 2021
Primary completion date
30 Aug 2023
Lead sponsor
Oppilan Pharma Ltd
NCT number
NCT05156125

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Diagnosis of Crohn's disease (CD) or indeterminate colitis or the presence or history of a fistula consistent with CD

Other

  • Severe extensive colitis
  • Diagnosis of microscopic colitis, ischemic colitis, or infectious colitis

Who the study is looking for

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

Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (77)

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RousseBulgariaUnknown status
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RousseBulgariaUnknown status
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Hradec KrálovéCzechiaUnknown status
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SlanýCzechiaUnknown status
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Ústí nad LabemCzechiaUnknown status
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BerlinGermanyUnknown status
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Brandenburg an der HavelGermanyUnknown status
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DuisburgGermanyUnknown status
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HalleGermanyUnknown status
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NordhausenGermanyUnknown status
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CaenFranceUnknown status
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NantesFranceUnknown status
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Vandœuvre-lès-NancyFranceUnknown status
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TbilisiGeorgiaUnknown status
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TbilisiGeorgiaUnknown status
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PaviaItalyUnknown status
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San Giovanni RotondoItalyUnknown status
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DaeguSouth KoreaUnknown status
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WŏnjuSouth KoreaUnknown status
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PanevezysLithuaniaUnknown status
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VilniusLithuaniaUnknown status
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BydgoszczPolandUnknown status
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Jelenia GóraPolandUnknown status
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LodzPolandUnknown status
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LublinPolandUnknown status
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OświęcimPolandUnknown status
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Piotrkow TrybunalskiPolandUnknown status
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RzeszówPolandUnknown status
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WroclawPolandUnknown status
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BelgradeSerbiaUnknown status
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BelgradeSerbiaUnknown status
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BelgradeSerbiaUnknown status
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ZrenjaninSerbiaUnknown status
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KošiceSlovakiaUnknown status
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PrešovSlovakiaUnknown status
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ŠahySlovakiaUnknown status
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AtlantaUnited StatesUnknown status
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DaytonUnited StatesUnknown status
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GarlandUnited StatesUnknown status
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LubbockUnited StatesUnknown status
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ShreveportUnited StatesUnknown status
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SouthlakeUnited StatesUnknown status
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TylerUnited StatesUnknown status
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VenturaUnited StatesUnknown status
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YpsilantiUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.