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

Accepts Healthy Volunteers

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

No
Study Type

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.

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

Trial ID:

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.

NCT03759041
Phase

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 2
Lead Sponsor

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

Seres Therapeutics, Inc.
Principal Investigator

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.
Agency Class

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

Industry
Overall Status Recruiting
Countries Canada, United States
Conditions

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

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).

Arms & Interventions

Arms

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)

Interventions

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.

(Investigator site), Phoenix, Arizona

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(Investigator site)

Phoenix, Arizona, 85018

(Investigator site), North Little Rock, Arkansas

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North Little Rock, Arkansas, 72117

(Investigator site), Chula Vista, California

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(Investigator site)

Chula Vista, California, 91910

(Investigator site), La Jolla, California

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La Jolla, California, 92037

(Investigator site), Lancaster, California

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Lancaster, California, 93534

(Investigator site), Los Angeles, California

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Los Angeles, California, 90067

(Investigator site), Mountain View, California

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Mountain View, California, 94040

(Investigator site), San Diego, California

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San Diego, California, 92103

(Investigator site), San Diego, California

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San Diego, California, 92123

(Investigator site), Wheat Ridge, Colorado

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Wheat Ridge, Colorado, 80033

(Investigator site), Danbury, Connecticut

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(Investigator site)

Danbury, Connecticut, 06810

(Investigator site), Hamden, Connecticut

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Hamden, Connecticut, 06518

(Investigator site), Boca Raton, Florida

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(Investigator site)

Boca Raton, Florida, 33487

(Investigator site), Clearwater, Florida

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(Investigator site)

Clearwater, Florida, 33762

(Investigator site), Crystal River, Florida

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(Investigator site)

Crystal River, Florida, 34429

(Investigator site), Edgewater, Florida

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(Investigator site)

Edgewater, Florida, 32132

(Investigator site), Fort Lauderdale, Florida

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(Investigator site)

Fort Lauderdale, Florida, 33308

(Investigator site), Hialeah, Florida

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(Investigator site)

Hialeah, Florida, 33012

(Investigator site), Jacksonville, Florida

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Jacksonville, Florida, 32256

(Investigator site), Miami, Florida

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Miami, Florida, 33136

(Investigator site), Miami, Florida

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Miami, Florida, 33176

(Investigator site), Naples, Florida

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(Investigator site)

Naples, Florida, 34102

(Investigator site), Naples, Florida

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(Investigator site)

Naples, Florida, 34102

(Investigator site), Ocala, Florida

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Ocala, Florida, 34474

(Investigator site), Orlando, Florida

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Orlando, Florida, 32803

(Investigator site), Pompano Beach, Florida

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(Investigator site)

Pompano Beach, Florida, 33060

(Investigator site), Port Orange, Florida

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(Investigator site)

Port Orange, Florida, 32127

(Investigator site), Tampa, Florida

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(Investigator site)

Tampa, Florida, 33609

(Investigator site), Tampa, Florida

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(Investigator site)

Tampa, Florida, 33609

(Investigator site), Athens, Georgia

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(Investigator site)

Athens, Georgia, 30607

(Investigator site), Atlanta, Georgia

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(Investigator site)

Atlanta, Georgia, 30322

(Investigator site), Marietta, Georgia

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(Investigator site)

Marietta, Georgia, 30060

(Investigator site), Chicago, Illinois

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(Investigator site)

Chicago, Illinois, 60611

(Investigator site), Chicago, Illinois

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(Investigator site)

Chicago, Illinois, 60612

(Investigator site), Chicago, Illinois

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(Investigator site)

Chicago, Illinois, 60637

(Investigator site), Indianapolis, Indiana

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(Investigator site)

Indianapolis, Indiana, 46202

(Investigator site), Pratt, Kansas

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(Investigator site)

Pratt, Kansas, 67124

(Investigator site), Lexington, Kentucky

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(Investigator site)

Lexington, Kentucky, 40536

(Investigator site), Lake Charles, Louisiana

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Lake Charles, Louisiana, 70601

(Investigator site), Metairie, Louisiana

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Metairie, Louisiana, 70006

(Investigator site), Monroe, Louisiana

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Monroe, Louisiana, 71201

(Investigator site), New Orleans, Louisiana

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New Orleans, Louisiana, 70115

(Investigator site), New Orleans, Louisiana

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New Orleans, Louisiana, 70121

(Investigator site), Shreveport, Louisiana

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Shreveport, Louisiana, 71105

(Investigator site), Baltimore, Maryland

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Baltimore, Maryland, 21287

(Investigator site), Glen Burnie, Maryland

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(Investigator site)

Glen Burnie, Maryland, 21208

(Investigator site), Ann Arbor, Michigan

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(Investigator site)

Ann Arbor, Michigan, 48109

(Investigator site), Farmington Hills, Michigan

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(Investigator site)

Farmington Hills, Michigan, 48334

(Investigator site), Rochester, Minnesota

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(Investigator site)

Rochester, Minnesota, 55905

(Investigator site), Bridgeton, Missouri

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Bridgeton, Missouri, 63044

(Investigator site), Creve Coeur, Missouri

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(Investigator site)

Creve Coeur, Missouri, 63141

(Investigator site), Las Vegas, Nevada

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Las Vegas, Nevada, 89123

(Investigator site), Reno, Nevada

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Reno, Nevada, 89511

(Investigator site), Lebanon, New Hampshire

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(Investigator site)

Lebanon, New Hampshire, 03756

(Investigator site), Brooklyn, New York

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Brooklyn, New York, 11235

(Investigator site), Great Neck, New York

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Great Neck, New York, 11021

(Investigator site), Hartsdale, New York

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Hartsdale, New York, 10530

(Investigator site), New York, New York

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New York, New York, 10016

(Investigator site), New York, New York

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New York, New York, 10016

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New York, New York, 10032

(Investigator site), Asheville, North Carolina

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Asheville, North Carolina, 28801

(Investigator site), Chapel Hill, North Carolina

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Chapel Hill, North Carolina, 27599

(Investigator site), Durham, North Carolina

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Durham, North Carolina, 27710

(Investigator site), Raleigh, North Carolina

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Raleigh, North Carolina, 27612

(Investigator site), Winston-Salem, North Carolina

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Winston-Salem, North Carolina, 27103

(Investigator site), Winston-Salem, North Carolina

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(Investigator site)

Winston-Salem, North Carolina, 27157

(Investigator site), Cincinnati, Ohio

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(Investigator site)

Cincinnati, Ohio, 45219

(Investigator site), Oklahoma City, Oklahoma

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(Investigator site)

Oklahoma City, Oklahoma, 73104

(Investigator site), Oklahoma City, Oklahoma

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(Investigator site)

Oklahoma City, Oklahoma, 73104

(Investigator site), Columbia, South Carolina

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(Investigator site)

Columbia, South Carolina, 29203

(Investigator site), Greenville, South Carolina

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(Investigator site)

Greenville, South Carolina, 29615

(Investigator site), Memphis, Tennessee

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(Investigator site)

Memphis, Tennessee, 38119

(Investigator site), Nashville, Tennessee

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(Investigator site)

Nashville, Tennessee, 37212

(Investigator site), Bedford, Texas

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(Investigator site)

Bedford, Texas, 76022

(Investigator site), Fort Sam Houston, Texas

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(Investigator site)

Fort Sam Houston, Texas, 78219

(Investigator site), Houston, Texas

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Houston, Texas, 77030

(Investigator site), Houston, Texas

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(Investigator site)

Houston, Texas, 77043

(Investigator site), Houston, Texas

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(Investigator site)

Houston, Texas, 77090

(Investigator site), McAllen, Texas

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(Investigator site)

McAllen, Texas, 78504

(Investigator site), San Antonio, Texas

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(Investigator site)

San Antonio, Texas, 78229

(Investigator site), Temple, Texas

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(Investigator site)

Temple, Texas, 76508

(Investigator site), Ogden, Utah

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(Investigator site)

Ogden, Utah, 84405

(Investigator site), Salt Lake City, Utah

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(Investigator site)

Salt Lake City, Utah, 84124

(Investigator site), Leesburg, Virginia

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(Investigator site)

Leesburg, Virginia, 20176

(Investigator site), Lynchburg, Virginia

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(Investigator site)

Lynchburg, Virginia, 24502

(Investigator site), Reston, Virginia

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(Investigator site)

Reston, Virginia, 20191

(Investigator site), Richmond, Virginia

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(Investigator site)

Richmond, Virginia, 23249

(Investigator site), Seattle, Washington

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(Investigator site)

Seattle, Washington, 98195

(Investigator site), Spokane, Washington

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(Investigator site)

Spokane, Washington, 99202

(Investigator site), Madison, Wisconsin

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(Investigator site)

Madison, Wisconsin, 53792

(Investigator site), Milwaukee, Wisconsin

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(Investigator site)

Milwaukee, Wisconsin, 53215

International Sites

(Investigator site), Edmonton, Alberta, Canada

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(Investigator site)

Edmonton, Alberta, T6G 2L7

(Investigator site), Edmonton, Alberta, Canada

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(Investigator site)

Edmonton, Alberta, T6G 2L7

(Investigator site), Edmonton, Alberta, Canada

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(Investigator site)

Edmonton, Alberta, T6L 6K3

(Investigator site), New Westminster, British Columbia, Canada

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(Investigator site)

New Westminster, British Columbia, V3L 3W4

(Investigator site), Bridgewater, Ontario, Canada

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(Investigator site)

Bridgewater, Ontario, B4V 3K9

(Investigator site), Lindsay, Ontario, Canada

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(Investigator site)

Lindsay, Ontario, K9V 5G6

(Investigator site), London, Ontario, Canada

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(Investigator site)

London, Ontario, N6A 5A5

(Investigator site), London, Ontario, Canada

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(Investigator site)

London, Ontario, N6A 5W9

(Investigator site), Sudbury, Ontario, Canada

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(Investigator site)

Sudbury, Ontario, P3C 5K6

(Investigator site), Toronto, Ontario, Canada

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(Investigator site)

Toronto, Ontario, M5T 3A9

(Investigator site), Vaughan, Ontario, Canada

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(Investigator site)

Vaughan, Ontario, L4L 4Y7

(Investigator site), Greenfield Park, Quebec, Canada

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Recruiting

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(Investigator site)

Greenfield Park, Quebec, J4V 2H1

(Investigator site), Saskatoon, Saskatchewan, Canada

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Recruiting

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(Investigator site)

Saskatoon, Saskatchewan, S7N 0W8

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