A Study to Assess Efficacy and Safety of SER‑287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 3/23/2019 |
Start Date: | December 19, 2018 |
End Date: | August 2021 |
Contact: | Sherry Weigand, MD, PhD |
Email: | clinicalstudies@serestherapeutics.com |
Phone: | 617-203-3492 |
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
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).
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).
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
We found this trial at
76
sites
Chapel Hill, North Carolina
Phone: 919-966-6806
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Farmington Hills, Michigan 48334
Phone: 248-716-7012
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Greenville, South Carolina 29605
Phone: 864-232-7338
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Mountain View, California 94040
Phone: 650-934-7000
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North Little Rock, Arkansas
Phone: 501-945-9300
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Winston-Salem, North Carolina
Phone: 336-713-7312
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