Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The Induction and Long-Term Extension Periods were completed and analyzed as planned. The Sponsor decided to terminate clinical conduct in the Open-Label Extension Period. The decision to terminate the study was not due to safety concerns.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colitis, Ulcerative | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| VTX002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- VTX002 Dose A
- description
- VTX002 Dose A tablet administered orally once daily
- interventionNames
- Drug: VTX002
- type
- EXPERIMENTAL
- label
- VTX002 Dose B
- description
- VTX002 Dose B tablet administered orally once daily
- interventionNames
- Drug: VTX002
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo tablet administered orally once daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSands BE, Panaccione R, D'Haens G, Schreiber S, Jairath V, DuVall A, Kierkus J, Walczak M, Naik S, Gilder K, Lindstrom B, Ogilvie K, Sandborn WJ, Vermeire S, Rubin DT, Peyrin-Biroulet L, Danese S. Tamuzimod in patients with moderately-to-severely active ulcerative colitis: a multicentre, double-blind, randomised, placebo-controlled, phase 2 induction trial. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):210-221. doi: 10.1016/S2468-1253(24)00386-8. Epub 2025 Jan 7. PMID 39793589