VE202 in Patients With Mild-to-Moderate Ulcerative Colitis

NCT05370885 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: VE202-0022021-001280-24
• Study Type: interventional
• Target: 114
• Locations: 10 countries
• Sites: 49

Brief Summary

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

Conditions

Ulcerative Colitis; Colitis, Ulcerative

Keywords

Ulcerative Colitis; VE202; Vedanta; Clostridia

Outcome Measures

Primary Outcomes (2)

• Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.

  Endoscopic response is defined as a reduction from baseline of 1 point or more in Mayo endoscopic subscore. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.

  8 Weeks

• Percentage of participants with Grade ≥ 3 Treatment-Emergent Adverse Events (TEAEs) that are treatment-related or Serious Adverse Events (SAEs) that are treatment-related in Part 1 and Part 2 of the study.

  The safety of VE202 and placebo in Parts 1 and 2 of the study, which include an 8-week and 2-week course of treatment, respectively, will be evaluated.

  16 Weeks

Secondary Outcomes (16)

• Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.

  8 Weeks

• Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.

  52 Weeks

• Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.

  8 Weeks

• Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.

  8 Weeks

• Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.

  8 Weeks

Study Arms (2)

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.

OTHER

In Part 1 of the study, patients in Group A will receive VE202 for 8 weeks. In Part 2 of the study, patients in Group A will receive VE202 placebo for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Biological: VE202; Drug: Vancomycin Oral Capsule; Other: VE202 Placebo; Other: Vancomycin Placebo

Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

OTHER

In Part 1 of the study, patients in Group B will receive VE202 placebo for 8 weeks. In Part 2 of the study, patients in Group B will receive VE202 for 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.

Biological: VE202; Drug: Vancomycin Oral Capsule; Other: VE202 Placebo; Other: Vancomycin Placebo

Interventions

VE202 BIOLOGICAL

VE202 is a rationally defined, live biotherapeutic product for oral administration.

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.; Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

Vancomycin Oral Capsule DRUG

Vancomycin is an antibiotic used to treat or prevent infection

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.; Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

VE202 Placebo OTHER

VE202 Placebo

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.; Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

Vancomycin Placebo OTHER

Vancomycin Placebo

Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment.; Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 75 years of age
• Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
• Active mild to moderate UC, as defined by the following:
• Disease that extends at least 15 cm from the anal verge
• A modified Mayo score of 4 to 8 with: (i.) Mayo endoscopic subscore of ≥ 2 based on screening flexible sigmoidoscopy; (ii.) Rectal bleeding score of ≥ 1
• Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
• If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
• Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

You may not qualify if:

• Known history of Crohn's disease (CD) or indeterminate colitis
• A known diagnosis of primary sclerosing cholangitis
• Allergy to VE202 or any of its components
• Allergy to vancomycin or any of its components
• A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
• Use of probiotics or herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of food products such as yogurt, kefir, kombucha, and herbal teas is permissible)
• Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
• Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
• Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer

Sponsors & Collaborators

• Vedanta Biosciences, Inc.: lead

Study Sites (49)

GI Pros Research

Naples, Florida, 34102, United States

Location

Revival Clinical Research

Orlando, Florida, 32807, United States

Location

Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD

Decatur, Georgia, 30033-6146, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

NYU IBD Center

New York, New York, 10016, United States

Location

Cornell University Weill Cornell Medicine New York Presbyterian Hospital

New York, New York, 10021, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Gastroenterology Research of America, LLC

San Antonio, Texas, 78229, United States

Location

University of Utah Hospitals and Clinics

Salt Lake City, Utah, 84132, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Mater Misericordiae Ltd and Mater Research Ltd

South Brisbane, Queensland, 4101, Australia

Location

St Vincent's Hospital Melbourne Department of Gastroenterology

Fitzroy, Victoria, 3065, Australia

Location

UMHAT Medica Ruse OOD

Rousse, 7013, Bulgaria

Location

Medical Centre Asklepion Main

Sofia, 1303, Bulgaria

Location

Vojenská nemocnice Brno, Interní oddělení

Brno, 61500, Czechia

Location

PreventaMed s.r.o, Vila zdraví

Olomouc, 77900, Czechia

Location

Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika

Budapest, 1088, Hungary

Location

Pannónia Magánorvosi Centrum Kft

Budapest, 1136, Hungary

Location

Dept. Gastroenterology, Univ. Debrecen

Debrecen, H-4032, Hungary

Location

Vilnius University Hospital Santaros klinikos

Vilnius, LT-08661, Lithuania

Location

Radboud Universitair Medisch Centrum

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

Location

Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa

Poznan, Greater Poland Voivodeship, 61-731, Poland

Location

Medrise Sp. z o.o.

Lublin, Lublin Voivodeship, 20-582, Poland

Location

MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point

Warsaw, Masovian Voivodeship, 04-501, Poland

Location

Centrum Medyczne "MEDYK"

Rzeszów, Podkarpackie Voivodeship, 35-326, Poland

Location

Endoskopia Sp. z o.o.

Sopot, Pomeranian Voivodeship, 81-756, Poland

Location

Vita Longa Sp. z o.o.

Katowice, 40748, Poland

Location

Solumed Centrum Medyczne

Poznan, 60-529, Poland

Location

Bonifraterskie Centrum Medyczne Sp. z o.o

Lodz, Łódź Voivodeship, 93-357, Poland

Location

M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center

Poltava, Poltavska, 36011, Ukraine

Location

Chernivtsi Regional Clinical Hospital

Chernivtsi, 03110, Ukraine

Location

Regional Clinical Hospital of the Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76000, Ukraine

Location

Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18

Kyiv, 01054, Ukraine

Location

Artes Medikum, Medial Center, Llc

Kyiv, 02002, Ukraine

Location

Medical Center OK!Clinic+

Kyiv, 02091, Ukraine

Location

National Institute of Surgery and Transplantology named after O. O. Shalimova

Kyiv, 03126, Ukraine

Location

LLC Medical Center "Consilium Medical"

Kyiv, 04050, Ukraine

Location

Volyn Regional Clinical hospital

Lutsk, 43000, Ukraine

Location

Ternopil Regional Clinical Hospital

Ternopil, 46002, Ukraine

Location

Uzhgorod City Multidisciplinary Clinical Hospital

Uzhhorod, 88009, Ukraine

Location

Transcarpathian Regional Clinical Hospital named after Andria Novak

Uzhhorod, 88018, Ukraine

Location

Vinnytsia Regional Clinical Hospital named after M.I. Pirogov

Vinnytsia, 21000, Ukraine

Location

Vinnytsia City Clinical Hospital No. 1

Vinnytsia, 21029, Ukraine

Location

UHB NHSFT Queen Elizabeth Hospital

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

Barts Health NHS TrustThe Royal London Hospital

London, E1 2AJ, United Kingdom

Location

King's College Hospital

London, SE5 9RS, United Kingdom

Location

Imperial College Healthcare NHS Trust - St Mary's Hospital

London, W2 1NY, United Kingdom

Location

Related Publications (1)

• Silber JL, Norman JM, Kanno T, Crossette EM, Szabady R, Menon R, Marko M, Hao LY, Tomsho L, Bhagat S, Yuan A, Olle B, Lamouse-Smith E. A randomized, double-blind, placebo-controlled, single- and multiple-dose phase 1 study of VE202, a defined bacterial consortium for treatment of inflammatory bowel disease: safety and colonization dynamics of a novel live biotherapeutic product in healthy adults. Eur J Gastroenterol Hepatol. 2026 Apr 1;38(4):437-441. doi: 10.1097/MEG.0000000000003098. Epub 2025 Oct 23.

  PMID: 41342324 DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Interventions

Vancomycin

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: May 12, 2022
• Study Start: May 8, 2023
• Primary Completion: August 29, 2025
• Study Completion: August 29, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-09

Locations

US (10); PL (8); CZ (2); UA (14); LI (1); AU (3); HU (3); BU (2); GB (4); NL (2)