A Study to Assess Efficacy and Safety of SER‑287 in Adults With Active Mild-to-Moderate Ulcerative Colitis

  • Interventional
  • Recruiting
  • NCT03759041
Eligibility Details Visit Clinicaltrials.gov

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

A 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

This is a Phase 2B randomized, double-blind, placebo-controlled, multiple dose, multicenter study designed to evaluate the efficacy, safety and microbiome alterations associated with two dose levels of SER-287, after pre-treatment with vancomycin, in adult subjects, age 18-80, with active mild-to-moderate ulcerative colitis (UC).

Gender
All

Age Group
18 Years to 80 Years

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Documented diagnosis of UC at least three months prior to screening, and with a minimum disease extent of 15 cm from the anal verge

         - Active mild-to-moderate UC

         - Inadequate response to, loss of response to, or intolerance of, at least one of the following conventional therapies: 5-ASA compounds, corticosteroids, 6-mercaptopurine (6-MP) or azathioprine (AZA), anti-TNFα, anti-integrin or tofacitinib

        Exclusion Criteria:

         - Known history of Crohn's disease

         - No previous history of treatment for UC (treatment-naïve)

         - Subjects on steroid medication who are unable to have steroids tapered and be completely off steroids at least two weeks prior to screening

         - Unable to stop steroid enemas or suppositories, or 5-ASA enemas or suppositories, at least two weeks prior to screening

         - Subjects who have received any investigational or approved biologic therapy within eight weeks or five half-lives prior to screening (whichever is longer)

         - Subjects who have received any investigational or approved non-biologic therapy, except for those specifically listed in the Permitted Concomitant Medications, for the treatment of underlying disease, within 30 days or five half-lives prior to screening (whichever is longer)

         - Major gastrointestinal surgery (not including appendectomy or cholecystectomy) within two months before screening, or any history of total colectomy

At a Glance

National Government IDNCT03759041

IRB#IRB18-1609

Lead SponsorSeres Therapeutics, Inc.

Lead PhysicianRussell D. Cohen

Collaborator(s)N/A

EligibilityAll
18 Years to 80 Years
Recruiting