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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509233-39-00

Acronym

VTX002-201

Enrollment

132

Registered

2024-09-20

Start date

2022-01-20

Completion date

2025-02-27

Last updated

2025-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderately to Severely Active Ulcerative Colitis

Brief summary

The proportion of participants with clinical remission at Week 13 using modified Mayo score (MMS)

Detailed description

The proportion of participants with endoscopic improvement at Week 13, The proportion of participants with symptomatic remission at Week 13, The proportion of participants with histologic remission at Week 13, The proportion of participants with endoscopic improvement-histologic remission at Week 13

Interventions

DRUGtamuzimod

DRUGVTX002 placebo film-coated tablets matching VTX002

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The proportion of participants with clinical remission at Week 13 using modified Mayo score (MMS)	—

Secondary

Measure	Time frame
The proportion of participants with endoscopic improvement at Week 13, The proportion of participants with symptomatic remission at Week 13, The proportion of participants with histologic remission at Week 13, The proportion of participants with endoscopic improvement-histologic remission at Week 13	—

Countries

Bulgaria, Czechia, Germany, Hungary, Italy, Lithuania, Poland, Slovakia

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026