A Phase 2B Randomized Double-Blind Placebo-Controlled Multiple Dose Multicenter Study to Assess Efficacy and Safety of SER 287 in Adults with Active Mild-to-Moderate Ulcerative Colitis

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 years - 80 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects able to provide written signed informed consent
    2. Subjects who are between the ages of 18 and 80 years old
    3. Subjects with documented diagnosis of ulcerative colitis
    4. Subjects with active mild-to-moderate UC
    5. Subjects must be willing to undergo a lower endoscopy
    6. Subjects with an inadequate response to, loss of response to, or intolerance of, at least one (1) of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFa, anti-integrin or tofacitinib
    7. Female subjects either not of childbearing potential or of childbearing potential and practicing at least one (1) highly effective method of birth control, including the barrier method, oral or parenteral contraceptives, a vasectomized partner or abstinence from sexual intercourse.

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

    1. Subjects with known history of Crohn’s disease
    2. Subjects with no previous history of treatment for UC
    3. Subjects on steroid medication who are unable to have steroids tapered
    4. Subjects who have received any investigational or approved biologic therapy
    5. Subjects who have received any investigational or approved non-biologic therapy
    6. Subjects with Major gastrointestinal surgery within two (2) months before Screening, or any history of total colectomy
    7. Subjects with active celiac disease
    8. Subjects with evidence of, or treatment for, Clostridium difficile infection, or other intestinal pathogen
    9. Subjects with Clostridium difficile positive stool
    10. Subjects who used oral antibiotics within 30 days before Screening
    11. Subjects who are expected to receive antibiotics
    12. Subjects who received an investigational drug or live vaccine within two (2) months
    13. Subjects who were previously enrolled in a Seres Therapeutics SER-109 or SER-287 study
    14. Subjects who received a fecal microbiota transplant
    15. Subjects with poor concurrent medical risks with clinically significant co-morbid disease
    16. Subjects with anatomic or medical contraindications to lower endoscopy
    17. Subjects unable to stop steroid enemas or suppositories
    18. Subjects unable to stop probiotic treatment
    19. Subjects with known active malignancy
    20. Subjects unable to comply with the protocol requirements
    21. Subjects with known allergy or intolerance to oral vancomycin
    22. Subjects with current or recent history of drug or alcohol abuse



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