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 Canada, 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

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), Milwaukee, Wisconsin

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Recruiting

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(Investigator site)

Milwaukee, Wisconsin, 53215

(Investigator site), Madison, Wisconsin

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Not yet recruiting

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(Investigator site)

Madison, Wisconsin, 53792

(Investigator site), Seattle, Washington

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Not yet recruiting

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(Investigator site)

Seattle, Washington, 98195

(Investigator site), Richmond, Virginia

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Recruiting

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(Investigator site)

Richmond, Virginia, 23249

(Investigator site), Reston, Virginia

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Not yet recruiting

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(Investigator site)

Reston, Virginia, 20191

(Investigator site), Lynchburg, Virginia

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Recruiting

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(Investigator site)

Lynchburg, Virginia, 24502

(Investigator site), Leesburg, Virginia

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Recruiting

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(Investigator site)

Leesburg, Virginia, 20176

(Investigator site), Salt Lake City, Utah

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Not yet recruiting

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(Investigator site)

Salt Lake City, Utah, 84124

(Investigator site), Ogden, Utah

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Recruiting

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(Investigator site)

Ogden, Utah, 84405

(Investigator site), Temple, Texas

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Not yet recruiting

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(Investigator site)

Temple, Texas, 76508

(Investigator site), San Antonio, Texas

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Recruiting

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(Investigator site)

San Antonio, Texas, 78229

(Investigator site), Houston, Texas

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Recruiting

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(Investigator site)

Houston, Texas, 77090

(Investigator site), Houston, Texas

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Recruiting

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(Investigator site)

Houston, Texas, 77043

(Investigator site), Houston, Texas

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Recruiting

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(Investigator site)

Houston, Texas, 77036

(Investigator site), Houston, Texas

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Not yet recruiting

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(Investigator site)

Houston, Texas, 77030

(Investigator site), Fort Sam Houston, Texas

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Not yet recruiting

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(Investigator site)

Fort Sam Houston, Texas, 78219

(Investigator site), Bedford, Texas

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Recruiting

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(Investigator site)

Bedford, Texas, 76022

(Investigator site), Nashville, Tennessee

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Not yet recruiting

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(Investigator site)

Nashville, Tennessee, 37212

(Investigator site), Nashville, Tennessee

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Recruiting

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(Investigator site)

Nashville, Tennessee, 37211

(Investigator site), Greenville, South Carolina

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Recruiting

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(Investigator site)

Greenville, South Carolina, 29615

(Investigator site), Columbia, South Carolina

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Recruiting

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(Investigator site)

Columbia, South Carolina, 29203

(Investigator site), Philadelphia, Pennsylvania

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Not yet recruiting

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(Investigator site)

Philadelphia, Pennsylvania, 19102

(Investigator site), Oklahoma City, Oklahoma

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Not yet recruiting

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(Investigator site)

Oklahoma City, Oklahoma, 73104

(Investigator site), Winston-Salem, North Carolina

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Not yet recruiting

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(Investigator site)

Winston-Salem, North Carolina, 27157

(Investigator site), Winston-Salem, North Carolina

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Recruiting

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(Investigator site)

Winston-Salem, North Carolina, 27103

(Investigator site), Raleigh, North Carolina

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Recruiting

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(Investigator site)

Raleigh, North Carolina, 27612

(Investigator site), Durham, North Carolina

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Not yet recruiting

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(Investigator site)

Durham, North Carolina, 27710

(Investigator site), Chapel Hill, North Carolina

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Recruiting

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(Investigator site)

Chapel Hill, North Carolina, 27599

(Investigator site), Asheville, North Carolina

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Recruiting

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(Investigator site)

Asheville, North Carolina, 28801

(Investigator site), New York, New York

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Not yet recruiting

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(Investigator site)

New York, New York, 10032

(Investigator site), New York, New York

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Not yet recruiting

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(Investigator site)

New York, New York, 10016

(Investigator site), New York, New York

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Recruiting

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(Investigator site)

New York, New York, 10016

(Investigator site), New Hyde Park, New York

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Not yet recruiting

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(Investigator site)

New Hyde Park, New York, 11040

(Investigator site), Hartsdale, New York

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Recruiting

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(Investigator site)

Hartsdale, New York, 10530

(Investigator site), Great Neck, New York

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Not yet recruiting

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(Investigator site)

Great Neck, New York, 11021

(Investigator site), Brooklyn, New York

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Not yet recruiting

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(Investigator site)

Brooklyn, New York, 11235

(Investigator site), Lebanon, New Hampshire

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Not yet recruiting

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(Investigator site)

Lebanon, New Hampshire, 03756

(Investigator site), Reno, Nevada

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Recruiting

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(Investigator site)

Reno, Nevada, 89511

(Investigator site), Creve Coeur, Missouri

Status

Recruiting

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(Investigator site)

Creve Coeur, Missouri, 63141

(Investigator site), Bridgeton, Missouri

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Recruiting

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(Investigator site)

Bridgeton, Missouri, 63044

(Investigator site), Rochester, Minnesota

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Not yet recruiting

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(Investigator site)

Rochester, Minnesota, 55905

(Investigator site), Farmington Hills, Michigan

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Recruiting

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(Investigator site)

Farmington Hills, Michigan, 48334

(Investigator site), Ann Arbor, Michigan

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Not yet recruiting

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(Investigator site)

Ann Arbor, Michigan, 48109

(Investigator site), Brockton, Massachusetts

Status

Recruiting

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(Investigator site)

Brockton, Massachusetts, 02302

(Investigator site), Boston, Massachusetts

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Not yet recruiting

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(Investigator site)

Boston, Massachusetts, 02215

(Investigator site), Glen Burnie, Maryland

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Recruiting

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(Investigator site)

Glen Burnie, Maryland, 21208

(Investigator site), Baltimore, Maryland

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Not yet recruiting

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(Investigator site)

Baltimore, Maryland, 21287

(Investigator site), Shreveport, Louisiana

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Recruiting

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(Investigator site)

Shreveport, Louisiana, 71105

(Investigator site), New Orleans, Louisiana

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Not yet recruiting

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(Investigator site)

New Orleans, Louisiana, 70121

(Investigator site), New Orleans, Louisiana

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Not yet recruiting

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(Investigator site)

New Orleans, Louisiana, 21287

(Investigator site), Monroe, Louisiana

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Recruiting

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(Investigator site)

Monroe, Louisiana, 71201

(Investigator site), Metairie, Louisiana

Status

Recruiting

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(Investigator site)

Metairie, Louisiana, 70006

(Investigator site), Lake Charles, Louisiana

Status

Recruiting

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(Investigator site)

Lake Charles, Louisiana, 70601

(Investigator site), Lexington, Kentucky

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Not yet recruiting

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(Investigator site)

Lexington, Kentucky, 40536

(Investigator site), Pratt, Kansas

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Recruiting

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(Investigator site)

Pratt, Kansas, 67124

(Investigator site), Indianapolis, Indiana

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Not yet recruiting

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(Investigator site)

Indianapolis, Indiana, 46202

(Investigator site), Chicago, Illinois

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Not yet recruiting

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(Investigator site)

Chicago, Illinois, 60637

(Investigator site), Chicago, Illinois

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Not yet recruiting

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(Investigator site)

Chicago, Illinois, 60612

(Investigator site), Chicago, Illinois

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Not yet recruiting

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(Investigator site)

Chicago, Illinois, 60611

(Investigator site), Marietta, Georgia

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Not yet recruiting

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(Investigator site)

Marietta, Georgia, 30060

(Investigator site), Atlanta, Georgia

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Not yet recruiting

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(Investigator site)

Atlanta, Georgia, 30342

(Investigator site), Atlanta, Georgia

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Not yet recruiting

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(Investigator site)

Atlanta, Georgia, 30322

(Investigator site), Athens, Georgia

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Not yet recruiting

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(Investigator site)

Athens, Georgia, 30607

(Investigator site), Port Orange, Florida

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Recruiting

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(Investigator site)

Port Orange, Florida, 32127

(Investigator site), Pompano Beach, Florida

Status

Recruiting

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(Investigator site)

Pompano Beach, Florida, 33060

(Investigator site), Orlando, Florida

Status

Recruiting

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(Investigator site)

Orlando, Florida, 32803

(Investigator site), Ocala, Florida

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Not yet recruiting

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(Investigator site)

Ocala, Florida, 34474

(Investigator site), Naples, Florida

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Recruiting

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(Investigator site)

Naples, Florida, 34102

(Investigator site), Miami, Florida

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Recruiting

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(Investigator site)

Miami, Florida, 33176

(Investigator site), Miami, Florida

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Not yet recruiting

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(Investigator site)

Miami, Florida, 33136

(Investigator site), Lakewood Ranch, Florida

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Not yet recruiting

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(Investigator site)

Lakewood Ranch, Florida, 34211

(Investigator site), Jacksonville, Florida

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Recruiting

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(Investigator site)

Jacksonville, Florida, 32256

(Investigator site), Edgewater, Florida

Status

Recruiting

Address

(Investigator site)

Edgewater, Florida, 32132

(Investigator site), Clearwater, Florida

Status

Recruiting

Address

(Investigator site)

Clearwater, Florida, 33762

(Investigator site), Hamden, Connecticut

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Recruiting

Address

(Investigator site)

Hamden, Connecticut, 06518

(Investigator site), Danbury, Connecticut

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Not yet recruiting

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(Investigator site)

Danbury, Connecticut, 06810

(Investigator site), Wheat Ridge, Colorado

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Recruiting

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(Investigator site)

Wheat Ridge, Colorado, 80033

(Investigator site), San Diego, California

Status

Recruiting

Address

(Investigator site)

San Diego, California, 92123

(Investigator site), San Diego, California

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Not yet recruiting

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(Investigator site)

San Diego, California, 92103

(Investigator site), Mountain View, California

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Not yet recruiting

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(Investigator site)

Mountain View, California, 94040

(Investigator site), Los Angeles, California

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Recruiting

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(Investigator site)

Los Angeles, California, 90067

(Investigator site), Los Angeles, California

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Not yet recruiting

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(Investigator site)

Los Angeles, California, 90032

(Investigator site), Long Beach, California

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Not yet recruiting

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(Investigator site)

Long Beach, California, 90822

(Investigator site), Lancaster, California

Status

Recruiting

Address

(Investigator site)

Lancaster, California, 93534

(Investigator site), La Jolla, California

Status

Not yet recruiting

Address

(Investigator site)

La Jolla, California, 92037

(Investigator site), Chula Vista, California

Status

Recruiting

Address

(Investigator site)

Chula Vista, California, 91910

(Investigator site), North Little Rock, Arkansas

Status

Recruiting

Address

(Investigator site)

North Little Rock, Arkansas, 72117

(Investigator site), Phoenix, Arizona

Status

Recruiting

Address

(Investigator site)

Phoenix, Arizona, 85018

(Investigator site), Huntsville, Alabama

Status

Recruiting

Address

(Investigator site)

Huntsville, Alabama, 35801

International Sites

(Investigator site), Saskatoon, Saskatchewan, Canada

Status

Not yet recruiting

Address

(Investigator site)

Saskatoon, Saskatchewan, S7N 0W8

(Investigator site), Greenfield Park, Quebec, Canada

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Not yet recruiting

Address

(Investigator site)

Greenfield Park, Quebec, J4V 2H1

(Investigator site), Vaughan, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

Vaughan, Ontario, L4L 4Y7

(Investigator site), Toronto, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

Toronto, Ontario, M5T 3A9

(Investigator site), Toronto, Ontario, Canada

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Not yet recruiting

Address

(Investigator site)

Toronto, Ontario, M3M 0B2

(Investigator site), Sudbury, Ontario, Canada

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Not yet recruiting

Address

(Investigator site)

Sudbury, Ontario, P3C 5K6

(Investigator site), Ottawa, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

Ottawa, Ontario, K1K 0T2

(Investigator site), London, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

London, Ontario, N6A 5W9

(Investigator site), London, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

London, Ontario, N6A 5A5

(Investigator site), Lindsay, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

Lindsay, Ontario, K9V 5G6

(Investigator site), Bridgewater, Ontario, Canada

Status

Not yet recruiting

Address

(Investigator site)

Bridgewater, Ontario, B4V 3K9

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

Status

Not yet recruiting

Address

(Investigator site)

New Westminster, British Columbia, V3L 3W4

(Investigator site), Edmonton, Alberta, Canada

Status

Not yet recruiting

Address

(Investigator site)

Edmonton, Alberta, T6L 6K3

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