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

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ulcerative Colitis

In brief

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

Key facts

Study ID

NCT03759041

Run by

Seres Therapeutics, Inc.

People needed

203

Starts

2018-12-19

Expected to finish

2021-10-13

Last updated by the study team

2022-08-12

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• (Investigator site) — North Little Rock, Arkansas, United States
• (Investigator site) — La Jolla, California, United States
• (Investigator site) — Lancaster, California, United States
• (Investigator site) — Los Angeles, California, United States
• (Investigator site) — Mountain View, California, United States
• (Investigator site) — San Diego, California, United States
• (Investigator site) — San Diego, California, United States
• (Investigator site) — Wheat Ridge, Colorado, United States
• (Investigator site) — Danbury, Connecticut, United States
• (Investigator site) — Hamden, Connecticut, United States
• (Investigator site) — Boca Raton, Florida, United States
• (Investigator site) — Clearwater, Florida, United States
• (Investigator site) — Crystal River, Florida, United States
• (Investigator site) — Fort Lauderdale, Florida, United States
• (Investigator site) — Hialeah, Florida, United States
• (Investigator site) — Jacksonville, Florida, United States
• (Investigator site) — Miami, Florida, United States
• (Investigator site) — Miami, Florida, United States
• (Investigator site) — Naples, Florida, United States
• (Investigator site) — Ocala, Florida, United States
• (Investigator site) — Orlando, Florida, United States
• (Investigator site) — Pompano Beach, Florida, United States
• (Investigator site) — Port Orange, Florida, United States
• (Investigator site) — Tampa, Florida, United States
• (Investigator site) — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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