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

Study Purpose

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

Recruitment Criteria

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Study Type
Interventional
Eligible Ages 18 Years - 80 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

Trial ID:
NCT03759041

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Seres Therapeutics, Inc.

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Sherry Weigand, MD, PhD
Principal Investigator Affiliation Seres Therapeutics, Inc.

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries United States

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
Ulcerative Colitis
Additional Details

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).

Contact a Trial Team

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Asheville, North Carolina

Status

Recruiting

Address

Asheville Gastroenterology Associates, P.A.

Asheville, North Carolina, 28801

Site Contact

Golden

617-203-3492

Nearest Location

Site Contact

Golden

617-203-3492

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