Clinical trial NCT05370885: VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Official title: Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study of VE202 in Patients With Mild-to-Moderate Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Ulcerative Colitis
Colitis, Ulcerative
Keywords: Ulcerative Colitis
VE202
Vedanta
Clostridia
Lead sponsor: Vedanta Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: KEY INCLUSION CRITERIA

1. 18 to 75 years of age
2. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
3. Active mild to moderate UC, as defined by the following:

   1. Disease that extends at least 15 cm from the anal verge
   2. 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
4. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulator for the treatment of UC
5. If receiving corticosteroids, dose must be stable for at least 4 weeks before randomization
6. Doses of other allowable UC medications must be stable for at least 8 weeks before randomization

KEY EXCLUSION CRITERIA

1. Known history of Crohn's disease (CD) or indeterminate colitis
2. A known diagnosis of primary sclerosing cholangitis
3. Allergy to VE202 or any of its components
4. Allergy to vancomycin or any of its components
5. A diagnosis of any non-IBD diarrheal illness (eg, Clostridioides difficile, celiac disease, parasitic infection) within 3 months prior to randomization
6. 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)
7. Receipt of Fecal Microbiota Transplantation (FMT) or other fecal-derived preparation within 6 months prior to randomization
8. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
9. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer

Primary outcomes:
measure: Proportion of participants with endoscopic response on flexible sigmoidoscopy after 8 weeks of treatment with VE202 or placebo.
timeFrame: 8 Weeks
measure: 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.
timeFrame: 16 Weeks
Secondary outcomes:
measure: Percentage of participants with endoscopic response on flexible sigmoidoscopy at Week 8, following treatment with VE202 for 2 weeks.
timeFrame: 8 Weeks
measure: Number of participants with TEAEs, SAEs, and Adverse Events of Special Interest (AESIs) in Parts 1, 2, and 3 of the study.
timeFrame: 52 Weeks
measure: Percentage of participants with clinical remission at Week 8 of Part 1 and Week 8 of Part 2.
timeFrame: 8 Weeks
measure: Percentage of participants with clinical response at Week 8 of Part 1 and Week 8 of Part 2.
timeFrame: 8 Weeks
measure: Percentage of participants with endoscopic remission on flexible sigmoidoscopy at Week 8 of Part 1 and Week 8 of Part 2.
timeFrame: 8 Weeks
measure: Change in Mayo score compared with baseline at Week 8 of Part 1 and Week 8 of Part 2.
timeFrame: 8 Weeks
measure: Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by Geboes score.
timeFrame: 8 Weeks
measure: Histologic improvement at Week 8 of Part 1 and Week 8 of Part 2 as measured by the Robarts Histopathology Index (RHI).
timeFrame: 8 Weeks
measure: Change in fecal calprotectin levels after 2- and 8-week courses of VE202.
timeFrame: 52 Weeks
measure: Change in colonization with VE202 strains detected in feces at various time points in patients treated with 2- and 8-week courses of VE202.
timeFrame: 52 Weeks
measure: 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.
timeFrame: 52 Weeks
measure: Change in taxonomic composition of gut microbiome in patients treated with 2- and 8-week courses of VE202.
timeFrame: 52 Weeks
measure: Change in fecal metabolite profiles at baseline and post-VE202 or placebo at various time points.
timeFrame: 52 Weeks
measure: Number of participants with hospitalization or surgical procedure related to UC after 2- and 8-week courses of VE202.
timeFrame: 52 weeks
measure: 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.
timeFrame: 52 Weeks
measure: 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.
timeFrame: 52 Weeks
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Clinical Applications Laboratories
state: California
city: Naples
country: United States
facility: GI Pros Research
state: Florida
city: New Port Richey
country: United States
facility: Advanced Research Institute, Inc.
state: Florida
city: Orlando
country: United States
facility: Revival Clinical Research
state: Florida
city: Orlando
country: United States
facility: Omega Research Orlando, LLC
state: Florida
city: Decatur
country: United States
facility: Atlanta Center for Gastroenterology, P.C. & Atlanta Endoscopy Center, LTD
state: Georgia
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: New York
country: United States
facility: NYU IBD Center
state: New York
city: New York
country: United States
facility: Cornell University Weill Cornell Medicine New York Presbyterian Hospital
state: New York
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of America, LLC
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Hospitals and Clinics
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd and Mater Research Ltd
state: Queensland
city: Fitzroy
country: Australia
facility: St Vincent's Hospital Melbourne Department of Gastroenterology
state: Victoria
city: Ruse
country: Bulgaria
facility: UMHAT Medica Ruse OOD
city: Sofia
country: Bulgaria
facility: Medical Centre Asklepion Main
city: Brno
country: Czechia
facility: Vojenská nemocnice Brno, Interní oddělení
city: Olomouc
country: Czechia
facility: PreventaMed s.r.o, Vila zdraví
city: Budapest
country: Hungary
facility: Semmelweis Egyetem Belgyógyászati és Hematológiai Klinika
city: Budapest
country: Hungary
facility: Pannónia Magánorvosi Centrum Kft
city: Debrecen
country: Hungary
facility: Dept. Gastroenterology, Univ. Debrecen
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros klinikos
city: Nijmegen
country: Netherlands
facility: Radboud Universitair Medisch Centrum
state: Gelderland
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Lublin
country: Poland
facility: Medrise Sp. z o.o.
state: Lubelskie
city: Warszawa
country: Poland
facility: MEDICAL NETWORK Sp. z o.o. WIP Warsaw IBD Point
state: Mazowieckie
city: Rzeszów
country: Poland
facility: Centrum Medyczne "MEDYK"
state: Podkarpackie
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
state: Pomorskie
city: Poznan
country: Poland
facility: Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Spółka komandytowa
state: Wielkopolskie
city: Katowice
country: Poland
facility: Vita Longa Sp. z o.o.
city: Poznań
country: Poland
facility: Solumed Centrum Medyczne
city: Łódź
country: Poland
facility: Bonifraterskie Centrum Medyczne Sp. z o.o
state: Łódzkie
city: Poltava
country: Ukraine
facility: M.Sklifosovsky Poltava Regional Clinical Hospital Regional Gastroenterology Center
state: Poltavska
city: Chernivtsi
country: Ukraine
facility: Chernivtsi Regional Clinical Hospital
city: Ivano-Frankivs'k
country: Ukraine
facility: Regional Clinical Hospital of the Ivano-Frankivsk Regional Council
city: Kyiv
country: Ukraine
facility: Municipal Nonprofit enterprise Kyiv City Clinical Hospital # 18
city: Kyiv
country: Ukraine
facility: Artes Medikum, Medial Center, Llc
city: Kyiv
country: Ukraine
facility: Medical Center OK!Clinic+
city: Kyiv
country: Ukraine
facility: National Institute of Surgery and Transplantology named after O. O. Shalimova
city: Kyiv
country: Ukraine
facility: LLC Medical Center "Consilium Medical"
city: Luts'k
country: Ukraine
facility: Volyn Regional Clinical hospital
city: Ternopil'
country: Ukraine
facility: Ternopil Regional Clinical Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital named after M.I. Pirogov
city: Vinnytsia
country: Ukraine
facility: Vinnytsia City Clinical Hospital No. 1
city: Úzhgorod
country: Ukraine
facility: Uzhgorod City Multidisciplinary Clinical Hospital
city: Úzhgorod
country: Ukraine
facility: Transcarpathian Regional Clinical Hospital named after Andria Novak
city: Birmingham
country: United Kingdom
facility: UHB NHSFT Queen Elizabeth Hospital
state: West Midlands
city: London
country: United Kingdom
facility: Barts Health NHS TrustThe Royal London Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust - St Mary's Hospital
Study officials:
References: