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
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								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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