Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
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.
|Eligible Ages||18 Years - 80 Years|
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
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.
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.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Seres Therapeutics, Inc.|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Sherry Weigand, MD, PhD|
|Principal Investigator Affiliation||Seres Therapeutics, Inc.|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Canada, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
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).
Placebo Comparator: Placebo (after placebo pre-treat.)
Once-daily dosing of Placebo (after placebo pre-treatment)
Experimental: SER-287 Induction Dosing (after vanco. pre-treat.)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Experimental: SER-287 Step-Down Induction Dosing (after vanco. pre-treat.)
Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Drug: - Vancomycin Pre-Treatment
Four times per day dosing of vancomycin pre-treatment
Drug: - Placebo for Vancomycin Pre-Treatment
Four times per day dosing of placebo pre-treatment
Drug: - SER-287
Once-daily dosing of SER-287
Drug: - Placebo for SER-287
Once-daily dosing of Placebo for SER-287
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.