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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-001280-24 | EudraCT Number |
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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.
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A Phase 2 study to evaluate the safety, efficacy, and microbiota changes of VE202 in patients with mild to moderate ulcerative colitis (UC).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VE202 | Biological | VE202 is a rationally defined, live biotherapeutic product for oral administration. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 Weeks |
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KEY INCLUSION CRITERIA
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
Doses of other allowable UC medications must be stable for at least 8 weeks before randomization
KEY EXCLUSION CRITERIA
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GI Pros Research | Naples | Florida | 34102 | United States | ||
| Revival Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41342324 | Derived | 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. |
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| Vancomycin Oral Capsule | Drug | Vancomycin is an antibiotic used to treat or prevent infection |
|
| VE202 Placebo | Other | VE202 Placebo |
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| Vancomycin Placebo | Other | Vancomycin Placebo |
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| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 52 Weeks |
| Orlando |
| Florida |
| 32807 |
| United States |
| Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD | Decatur | Georgia | 30033-6146 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| NYU IBD Center | New York | New York | 10016 | United States |
| Cornell University Weill Cornell Medicine New York Presbyterian Hospital | New York | New York | 10021 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Gastroenterology Research of America, LLC | San Antonio | Texas | 78229 | United States |
| University of Utah Hospitals and Clinics | Salt Lake City | Utah | 84132 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Concord Repatriation General Hospital | Concord | New South Wales | 2139 | Australia |
| Mater Misericordiae Ltd and Mater Research Ltd | South Brisbane | Queensland | 4101 | Australia |
| St Vincent's Hospital Melbourne Department of Gastroenterology | Fitzroy | Victoria | 3065 | Australia |
| UMHAT Medica Ruse OOD | Rousse | 7013 | Bulgaria |
| Medical Centre Asklepion Main | Sofia | 1303 | Bulgaria |
| Vojenská nemocnice Brno, Interní oddělení | Brno | 61500 | Czechia |
| PreventaMed s.r.o, Vila zdraví | Olomouc | 77900 | Czechia |
| Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika | Budapest | 1088 | Hungary |
| Pannónia Magánorvosi Centrum Kft | Budapest | 1136 | Hungary |
| Dept. Gastroenterology, Univ. Debrecen | Debrecen | H-4032 | Hungary |
| Vilnius University Hospital Santaros klinikos | Vilnius | LT-08661 | Lithuania |
| Radboud Universitair Medisch Centrum | Nijmegen | Gelderland | 6525 GA | Netherlands |
| Leiden University Medical Center | Leiden | 2333 ZA | Netherlands |
| Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa | Poznan | Greater Poland Voivodeship | 61-731 | Poland |
| Medrise Sp. z o.o. | Lublin | Lublin Voivodeship | 20-582 | Poland |
| MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point | Warsaw | Masovian Voivodeship | 04-501 | Poland |
| Centrum Medyczne "MEDYK" | Rzeszów | Podkarpackie Voivodeship | 35-326 | Poland |
| Endoskopia Sp. z o.o. | Sopot | Pomeranian Voivodeship | 81-756 | Poland |
| Vita Longa Sp. z o.o. | Katowice | 40748 | Poland |
| Solumed Centrum Medyczne | Poznan | 60-529 | Poland |
| Bonifraterskie Centrum Medyczne Sp. z o.o | Lodz | Łódź Voivodeship | 93-357 | Poland |
| M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center | Poltava | Poltavska | 36011 | Ukraine |
| Chernivtsi Regional Clinical Hospital | Chernivtsi | 03110 | Ukraine |
| Regional Clinical Hospital of the Ivano-Frankivsk Regional Council | Ivano-Frankivsk | 76000 | Ukraine |
| Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18 | Kyiv | 01054 | Ukraine |
| Artes Medikum, Medial Center, Llc | Kyiv | 02002 | Ukraine |
| Medical Center OK!Clinic+ | Kyiv | 02091 | Ukraine |
| National Institute of Surgery and Transplantology named after O. O. Shalimova | Kyiv | 03126 | Ukraine |
| LLC Medical Center "Consilium Medical" | Kyiv | 04050 | Ukraine |
| Volyn Regional Clinical hospital | Lutsk | 43000 | Ukraine |
| Ternopil Regional Clinical Hospital | Ternopil | 46002 | Ukraine |
| Uzhgorod City Multidisciplinary Clinical Hospital | Uzhhorod | 88009 | Ukraine |
| Transcarpathian Regional Clinical Hospital named after Andria Novak | Uzhhorod | 88018 | Ukraine |
| Vinnytsia Regional Clinical Hospital named after M.I. Pirogov | Vinnytsia | 21000 | Ukraine |
| Vinnytsia City Clinical Hospital No. 1 | Vinnytsia | 21029 | Ukraine |
| UHB NHSFT Queen Elizabeth Hospital | Birmingham | West Midlands | B15 2TH | United Kingdom |
| Barts Health NHS TrustThe Royal London Hospital | London | E1 2AJ | United Kingdom |
| King's College Hospital | London | SE5 9RS | United Kingdom |
| Imperial College Healthcare NHS Trust - St Mary's Hospital | London | W2 1NY | United Kingdom |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D014640 | Vancomycin |
| ID | Term |
|---|---|
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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