Ulcerative ColitisPhase 2NCT05370885
VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
A Phase 2 study testing VE202 and Vancomycin Oral Capsule in people with Ulcerative Colitis and Colitis, Ulcerative, run by Vedanta Biosciences, Inc. at 49 sites in 10 countries.
Trial summary
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Ulcerative Colitis, Colitis, Ulcerative
- What is being tested?
- VE202 and Vancomycin Oral Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 49 sitesin 10 countries
- Study dates
- 8 May 2023to 29 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 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
Who cannot join
- 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)
Show all 9Show fewer
- 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
Trial locations and contacts
49 sites in 10 countries.
49 sites in 10 countries
Ukraine14 sites
Chernivtsi Regional Clinical Hospital
Chernivtsi, 03110
Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 76000
Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18
Kyiv, 01054
Artes Medikum, Medial Center, Llc
Kyiv, 02002
Medical Center OK!Clinic+
Kyiv, 02091
National Institute of Surgery and Transplantology named after O. O. Shalimova
Kyiv, 03126
LLC Medical Center "Consilium Medical"
Kyiv, 04050
Volyn Regional Clinical hospital
Lutsk, 43000
M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center
Poltava, Poltavska, 36011
Ternopil Regional Clinical Hospital
Ternopil, 46002
Uzhgorod City Multidisciplinary Clinical Hospital
Uzhhorod, 88009
Transcarpathian Regional Clinical Hospital named after Andria Novak
Uzhhorod, 88018
Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
Vinnytsia, 21000
Vinnytsia City Clinical Hospital No. 1
Vinnytsia, 21029
United States10 sites
Boston Medical Center
Boston, Massachusetts, 02118
University of Virginia Health System
Charlottesville, Virginia, 22908
Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
Decatur, Georgia, 30033-6146
Baylor College of Medicine
Houston, Texas, 77030
GI Pros Research
Naples, Florida, 34102
NYU IBD Center
New York, New York, 10016
Cornell University Weill Cornell Medicine New York Presbyterian Hospital
New York, New York, 10021
Revival Clinical Research
Orlando, Florida, 32807
University of Utah Hospitals and Clinics
Salt Lake City, Utah, 84132
Gastroenterology Research of America, LLC
San Antonio, Texas, 78229
Poland8 sites
Vita Longa Sp. z o.o.
Katowice, 40748
Bonifraterskie Centrum Medyczne Sp. z o.o
Lodz, Łódź Voivodeship, 93-357
Medrise Sp. z o.o.
Lublin, Lublin Voivodeship, 20-582
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
Poznan, Greater Poland Voivodeship, 61-731
Solumed Centrum Medyczne
Poznan, 60-529
Centrum Medyczne "MEDYK"
Rzeszów, Podkarpackie Voivodeship, 35-326
Endoskopia Sp. z o.o.
Sopot, Pomeranian Voivodeship, 81-756
MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
Warsaw, Masovian Voivodeship, 04-501
United Kingdom4 sites
UHB NHSFT Queen Elizabeth Hospital
Birmingham, West Midlands, B15 2TH
Barts Health NHS TrustThe Royal London Hospital
London, E1 2AJ
King's College Hospital
London, SE5 9RS
Imperial College Healthcare NHS Trust - St Mary's Hospital
London, W2 1NY
Australia3 sites
Concord Repatriation General Hospital
Concord, New South Wales, 2139
St Vincent's Hospital Melbourne Department of Gastroenterology
Fitzroy, Victoria, 3065
Mater Misericordiae Ltd and Mater Research Ltd
South Brisbane, Queensland, 4101
Hungary3 sites
Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
Budapest, 1088
Pannónia Magánorvosi Centrum Kft
Budapest, 1136
Dept. Gastroenterology, Univ. Debrecen
Debrecen, H-4032
Bulgaria2 sites
UMHAT Medica Ruse OOD
Rousse, 7013
Medical Centre Asklepion Main
Sofia, 1303
Czechia2 sites
Vojenská nemocnice Brno, Interní oddělení
Brno, 61500
PreventaMed s.r.o, Vila zdraví
Olomouc, 77900
Netherlands2 sites
Leiden University Medical Center
Leiden, 2333 ZA
Radboud Universitair Medisch Centrum
Nijmegen, Gelderland, 6525 GA
Lithuania1 site
Vilnius University Hospital Santaros klinikos
Vilnius, LT-08661
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Read the detailed description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
- Conditions
- Ulcerative Colitis, Colitis, Ulcerative
- Being tested
- VE202, Vancomycin Oral Capsule, VE202 Placebo, Vancomycin Placebo
- Keywords
- Ulcerative Colitis, VE202, Vedanta, Clostridia
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VE202Biological
VE202 is a rationally defined, live biotherapeutic product for oral administration.
Vancomycin Oral CapsuleDrug
Vancomycin is an antibiotic used to treat or prevent infection
VE202 PlaceboOther
VE202 Placebo
Vancomycin PlaceboOther
Vancomycin Placebo
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Biological: VE202; Drug: Vancomycin Oral Capsule; Other: VE202 Placebo; Other: Vancomycin Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 16 Weeks
Secondary outcomes (16)
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
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.
Measured: 8 Weeks
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
The safety of VE202 and placebo in Parts 1, 2, and 3 of the study, which include an 8-week and 2-week course of treatment followed by a long-term follow-up period, will be evaluated. AESIs are defined as treatment-related Grade ≥2 TEAEs that are gastrointestinal or bacterial infections.
Measured: 52 Weeks
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical remission is defined as attaining a Mayo stool frequency subscore of ≤1 and an improvement in stool frequency subscore of ≥1 point from baseline, a rectal bleeding subscore of 0 and an endoscopic subscore ≤1. Each component of the Mayo score is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Measured: 8 Weeks
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Clinical response is defined as having met the definition of clinical remission or having a decrease from baseline of ≥2 points and a decrease of ≥30% in modified Mayo score, with either a rectal bleeding score of 0 or a decrease in rectal bleeding of ≥1 point. Each component of the modified Mayo score (stool frequency, rectal bleeding, endoscopy findings) is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Measured: 8 Weeks
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. Endoscopic response is defined as a Mayo endoscopic subscore of 0 or 1 point. The Mayo endoscopic subscore is evaluated on a scale of 0 to 3, with a higher score representing more severe disease.
Measured: 8 Weeks
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Mayo score is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician global assessment), with each parameter evaluated on a scale of 0 to 3. The total score ranges from 0 to 12, and a higher score represents more severe disease.
Measured: 8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The Geboes score encompasses 6 dimensions, each with 4 subcategories: architectural changes, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in the epithelium, crypt destruction, and erosions or ulcerations. The Geboes score ranges from grade 0 to 5.4. A higher Geboes score represents more severe disease.
Measured: 8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Participants will receive 8 weeks of VE202/placebo in Part 1 and 2 weeks of VE202/placebo in Part 2. The RHI provides a score between 0 and 33, based on the levels of chronic inflammatory infiltrate, neutrophils in lamina propria and epithelium, and erosion/ulceration. A higher RHI score represents more severe disease.
Measured: 8 Weeks
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
The change in fecal calprotectin level from baseline will be evaluated.
Measured: 52 Weeks
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Measured: 52 Weeks
Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202.
VE202 colonization will be characterized in patients treated with 2- and 8-week courses of VE202.
Measured: 52 Weeks
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
Microbiome composition will be evaluated by measuring the sum of species and the genera or higher-level taxonomic groupings at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Measured: 52 Weeks
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Short-chain fatty acid and bile acid concentrations will be evaluated at baseline and at subsequent time points in patients treated with 2- and 8-week courses of VE202 or placebo.
Measured: 52 Weeks
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
To evaluate the impact of 2- and 8-week courses of VE202 on Inflammatory bowel disease (IBD) specific healthcare resource utilization.
Measured: 52 weeks
Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
The 32-item IBDQ uses a 7-point scale to assess disease-specific health-related quality of life across 4 dimensions: bowel symptoms, systemic symptoms, emotional wellbeing, and social function. The total IBDQ score is calculated by adding the scores within each domain. Scores can range from 32 to 224, with a higher score indicating a better outcome.
Measured: 52 Weeks
Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
The EuroQoL-5D Health Assessment Questionnaire (EQ-5D) is a standardized, self-administered, non-disease-specific instrument for measuring generic health status for routine clinical outcome measurement in the delivery of operational healthcare. Scores range from 0 to 100, with a higher score indicating better outcome.
Measured: 52 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start8 May 2023
- Primary completion29 Aug 2025
- Study completion29 Aug 2025
Why it stopped: Following review of Part 1 study data, the Sponsor decided to terminate the study with immediate effect. Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vedanta Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05370885
- Sponsor's protocol ID
- VE202-002
- Other IDs
- 2021-001280-24
- Status last verified
- Sep 2025
- First submitted
- 30 Mar 2022
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
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.
PubMed 41342324
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT05370885
- Acronym / sponsor ID
- VE202-002
- Conditions
- Ulcerative Colitis, Colitis, Ulcerative
- Keywords
- Ulcerative Colitis, VE202, Vedanta, Clostridia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Following review of Part 1 study data, the Sponsor decided to terminate the study with immediate effect. Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed.
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Vedanta Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 May 2023 (actual)
- Primary completion
- 29 Aug 2025 (actual)
- Study completion
- 29 Aug 2025 (actual)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
Detailed description
A Phase 2 double-blind, placebo-controlled, randomized study to evaluate the safety, efficacy, and microbiota changes of VE202 in biologic-naïve patients with mild to moderate UC. In Parts 1 and 2 of the study, patients will receive VE202 or placebo for 8 weeks or 2 weeks. In Part 3, patients will be followed for safety for 1 year from the start of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Part 1 Active and Part 2 Placebo Treatment with Vancomycin pretreatment. | Other | Biological: VE202, Drug: Vancomycin Oral Capsule, Other: VE202 Placebo, Other: Vancomycin PlaceboIn 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. |
| Group B: Part 1 Placebo and Part 2 Active Treatment with Vancomycin pretreatment. | Other | Biological: VE202, Drug: Vancomycin Oral Capsule, Other: VE202 Placebo, Other: Vancomycin PlaceboIn 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 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:
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VE202VE202 is a rationally defined, live biotherapeutic product for oral administration. | Biological | 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 CapsuleVancomycin is an antibiotic used to treat or prevent infection | Drug | 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 PlaceboVE202 Placebo | Other | 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 PlaceboVancomycin Placebo | Other | 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. |
Primary outcome
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
Time frame: 8 Weeks
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.
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.
Time frame: 16 Weeks
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 secondary outcomes
Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
Time frame: 8 Weeks
Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
Time frame: 52 Weeks
Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
Time frame: 8 Weeks
Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
Time frame: 8 Weeks
Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
Time frame: 8 Weeks
Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
Time frame: 8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
Time frame: 8 Weeks
Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
Time frame: 8 Weeks
Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
Time frame: 52 Weeks
Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
Time frame: 52 Weeks
Change in the total percent of relative abundance of VE202 strains in feces at various time points in patients treated with 2- and 8-week courses of VE202.
Time frame: 52 Weeks
Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
Time frame: 52 Weeks
Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
Time frame: 52 Weeks
Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
Time frame: 52 weeks
Change in patient-reported outcome measures using the Inflammatory Bowel Disease Questionnaire (IBDQ) to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
Time frame: 52 Weeks
Change in patient-reported outcome measures using the EuroQoL-5D Health Assessment Questionnaire (EQ-5D) scores to evaluate the impact of 2- and 8-week courses of VE202 IBD-specific health-related quality of life.
Time frame: 52 Weeks
Results and safety
The study was stopped early (reason given: Following review of Part 1 study data, the Sponsor decided to terminate the study with immediate effect. Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Derived from this study: PubMed 41342324Silber 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
49 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing VE202 and Vancomycin Oral Capsule in people with Ulcerative Colitis and Colitis, Ulcerative, run by Vedanta Biosciences, Inc. at 49 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Ukraine, United States, Poland, United Kingdom, Australia and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Following review of Part 1 study data, the Sponsor decided to terminate the study with immediate effect. Results indicated that VE202 was not superior to placebo on the primary or any of the secondary endpoints. No new safety concerns were observed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo. (time frame: 8 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05370885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.