ECO-RESET: 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 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects providing signed and dated written informed consent
    2. Subjects who are between 18 - 80 years old
    3. Subjects documented diagnosis of ulcerative colitis at least three (3) months prior to Screening, and with a minimum disease extent of 15 cm from the anal verge
    4. Subjects with active mild-to-moderate UC
    5. Subjects 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. If female, she is not of childbearing potential, defined as postmenopausal or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy b. Of childbearing potential and participates in any activity associated with risk of pregnancy: is 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.
    8. If male and partner is of childbearing potential, subject agrees to practice at least one (1) highly effective method of birth control for the duration of the study.

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

    1. Subjects with known history of Crohn’s disease
    2. Subjects had no previous history of treatment for UC
    3. Subjects on steroid medication who are unable to have steroid medication
    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 who had major gastrointestinal surgery
    7. Subjects with active celiac disease
    8. Subjects with evidence of, or treatment for, Clostridium difficile infection, or other intestinal pathogen, within 30 days prior to Screening
    9. Subjects with Clostridium difficile positive stool, performed with a toxin enzyme immunoassay (EIA) by the Central Laboratory
    10. Subjects with oral antibiotic use within 30 days before Screening
    11. Subjects expected to receive antibiotics.
    12. Subjects who received an investigational drug or live vaccine within two (2) months before Screening
    13. Subjects who 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 or 5-ASA enemas or suppositories
    18. Subjects unable to stop probiotic treatment at least one (1) week prior to Screening
    19. Subjects with known active malignancy except for basal cell skin cancer or squamous cell skin cancer, or concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy
    20. Subjects unable to comply with the protocol requirements
    21. Subjects with known allergy or intolerance to oral vancomycin

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