NCT05370885

VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

Terminated Phase 2 Last updated 17 December 2025

What this trial tests

Phase 2 trial testing VE202 in Ulcerative Colitis in 114 participants. Terminated before completion.

Timeline

8 May 2023

Primary endpoint
29 August 2025

29 August 2025

Quick facts

Lead sponsor	Vedanta Biosciences, Inc.
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	114
Start date	8 May 2023
Primary completion	29 August 2025
Estimated completion	29 August 2025
Sites	49 locations across Netherlands, Ukraine, United Kingdom, Hungary, Poland, Lithuania, Bulgaria, Australia

Drugs / interventions tested

• VE202 — full drug profile →
• Vancomycin Oral Capsule
• VE202 Placebo
• Vancomycin Placebo

Conditions studied

• Ulcerative Colitis — all drugs for Ulcerative Colitis →
• Colitis, Ulcerative — all drugs for Colitis, Ulcerative →

Sponsor

Vedanta Biosciences, Inc. — full company profile →

Who can join

Adults 18 to 75, any sex, with Ulcerative Colitis or Colitis, Ulcerative. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Microbiota in inflammatory bowel disease: mechanisms of disease and therapeutic opportunities.
   Iliev ID, Ananthakrishnan AN, Guo CJ. · · 2025 · cited 75× · PMID 40065181 · DOI 10.1038/s41579-025-01163-0
2. <i>Lachnospiraceae</i> are emerging industrial biocatalysts and biotherapeutics.
   Zaplana T, Miele S, Tolonen AC. · · 2023 · cited 57× · PMID 38239921 · DOI 10.3389/fbioe.2023.1324396
3. Gut microbiome therapy: fecal microbiota transplantation vs live biotherapeutic products.
   Kim DY, Lee SY, Lee JY, Whon TW, et al · · 2024 · cited 18× · PMID 39377231 · DOI 10.1080/19490976.2024.2412376
4. Precision microbiota therapy for IBD: premise and promise.
   Nagayama M, Gogokhia L, Longman RS. · · 2025 · cited 16× · PMID 40190259 · DOI 10.1080/19490976.2025.2489067
5. The regulatory framework for microbiome-based therapies: insights into European regulatory developments.
   Rodriguez J, Cordaillat-Simmons M, Pot B, Druart C. · · 2025 · cited 13× · PMID 40155609 · DOI 10.1038/s41522-025-00683-0
6. The human microbiome in clinical translation: from bench to bedside.
   Bautista J, Echeverría CE, Maldonado-Noboa I, Ojeda-Mosquera S, et al · · 2025 · cited 11× · PMID 41035896 · DOI 10.3389/fmicb.2025.1632435
7. Microbiota-Based Live Biotherapeutic Products for <i>Clostridioides Difficile</i> Infection- The Devil is in the Details.
   Monday L, Tillotson G, Chopra T. · · 2024 · cited 9× · PMID 38375101 · DOI 10.2147/idr.s419243
8. Gastrointestinal microbiota-directed nutritional and therapeutic interventions for inflammatory bowel disease: opportunities and challenges.
   Paudel D, Nair DVT, Joseph G, Castro R, et al · · 2024 · cited 8× · PMID 38690290 · DOI 10.1093/gastro/goae033