Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients with Mild-to-Moderate Ulcerative Colitis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512558-40-00

Acronym

VE202-002

Enrollment

Registered

2024-10-11

Start date

2023-05-11

Completion date

2025-08-11

Last updated

2025-07-28

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

Conditions

Mild-to-moderate ulcerative colitis

Brief summary

Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56, Grade ≥ 3 Treatment-emergent adverse event (TEAEs) that are related to VE202 or VE202 placebo, Serious adverse event (SAEs) that are related to VE202 or VE202 placebo, OPEN-LABEL PORTION (PART 4): TEAEs, SAEs, AESIs, MAAEs

Interventions

DRUGVANCOMYCIN HYDROCHLORIDE

DRUGVE202

DRUGVE202 Placebo drug product (DP) is microcrystalline cellulose filled into a size 0 Vcaps® Enteric-coated capsule.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Endoscopic response rate defined as a reduction of 1 point or more in Mayo endoscopic subscore on flexible sigmoidoscopy from baseline to Day 56, Grade ≥ 3 Treatment-emergent adverse event (TEAEs) that are related to VE202 or VE202 placebo, Serious adverse event (SAEs) that are related to VE202 or VE202 placebo, OPEN-LABEL PORTION (PART 4): TEAEs, SAEs, AESIs, MAAEs	—

Countries

Bulgaria, Czechia, Hungary, Lithuania, Netherlands, Poland

Outcome results

None listed

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