Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  Ulcerative Colitis
• Age: Between 18 Year(s) - 75 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. Able and willing to provide written informed consent
  2. 18 to 75 years of age
  3. Documented clinical and endoscopic diagnosis of UC at least 3 months prior to randomization
  4. Active mild to moderate UC
  5. Is up to date with current local colorectal cancer surveillance recommendations (eg, has had a surveillance colonoscopy within 12 months if indicated based on extent and duration of UC); this may be performed during screening
  6. Has never received a biologic agent, Janus kinase inhibitor, or sphingosine-1-phosphate modulators for the treatment of UC
  7. May be on corticosteroids, maximum dose of 10 mg QD prednisone (or prednisone equivalent) or budesonide 9 mg QD, if dose is stable for at least 4 weeks
  8. Other allowable medications (eg, mesalamine, 6-mercaptopurine) at a stable dose for at least
  9. If a female patient (according to sex assignment at birth):
     • Is not of childbearing potential, defined as post-menopausal for at least 1 year or surgically sterile due to hysterectomy, bilateral oophorectomy, or bilateral tubal ligation
     • If of childbearing potential, must have a negative pregnancy test and agree to either remain celibate or use a highly effective form of birth control from the time of enrollment until 3 months after the last dose of study drug
     • Agrees not to donate eggs (ova, oocytes) for purposes of assisted reproduction from the time of enrollment until 3 months after the last dose of study drug
     • Is not breastfeeding
  10. If a male patient (according to sex assignment at birth):
      • If not vasectomized, agrees to wear a condom when engaging in sexual intercourse with any partner of childbearing potential from the time of enrollment until 3 months after the last dose of study drug
      • Agrees not to donate sperm for purpose of reproduction from the time of enrollment until 3 months after the last dose of study drug

  
  

You may not be eligible for this study if the following are true:

• 1. Known history of Crohn’s Disease 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. Known or suspected toxic megacolon, abdominal abscess, and/or small bowel ileus at the time of screening
  7. Any other anatomic or medical contraindication to flexible sigmoidoscopy
  8. Evidence of an active infection
  9. Recent fever, defined as > 38.0 °C (rectal equivalent) within 3 days prior to randomization
  10. Receipt of FMT (fecal microbiota transplantation) or other fecal-derived preparation within 6 months prior to randomization
  11. Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks before randomization or anticipated within the study period
  12. Use of probiotics within the prior 2 weeks before randomization (consumption of food products such as yogurt, kombucha, kimchi, and kefir is permissible)
  13. Receipt of herbal, botanical, or traditional medicinal preparations within the 2 weeks prior to randomization (consumption of mint, turmeric, or other herbal teas is permissible)
  14. Active drug or alcohol abuse
  15. Active colonic dysplasia
  16. Presence of adenomatous polyp on screening endoscopy, or history of adenomatous polyps that were not removed
  17. Prior colectomy, ostomy, or other intestinal surgery (excluding cholecystectomy or appendectomy)
  18. Active malignancy within the 2 years prior to randomization, with the exception of non-melanoma skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast that has been treated with local excision for curative intent
  19. For female patients (according to sex assignment at birth), expectation of pregnancy or lactation during the study period
  20. Receipt of any investigational drug or vaccine within the 30 days prior to randomization
  21. Receipt of any investigational biologic within 60 days or 5 half-lives prior to randomization, whichever is longer
  22. Known active hepatitis B or hepatitis C, or any positive laboratory result consistent with active disease (eg, hepatitis B surface antigen, hepatitis C antibody [unless patient has a history of treatment with successful resolution and an undetectable viral load])
  23. Known human immunodeficiency virus infection or other serious congenital or acquired immunodeficiency
  24. Inability or unwillingness to comply with protocol requirements