Status:
TERMINATED
A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Lead Sponsor:
Seres Therapeutics, Inc.
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
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
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 13 2021
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT03759041
Start Date
December 19 2018
End Date
October 13 2021
Last Update
August 12 2022
Active Locations (93)
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1
(Investigator site)
Phoenix, Arizona, United States, 85018
2
(Investigator site)
North Little Rock, Arkansas, United States, 72117
3
(Investigator site)
La Jolla, California, United States, 92037
4
(Investigator site)
Lancaster, California, United States, 93534