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

Use our guide to learn which trials are right for you!

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

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).

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
Salt Lake City, Utah
Phone: 801-263-3041
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Ann Arbor, Michigan 48109
Phone: 734-647-2964
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Asheville, North Carolina
Phone: 828-254-0881
?
mi
from
Asheville, NC
Click here to add this to my saved trials
Athens, Georgia 30607
Phone: 706-461-5454
?
mi
from
Athens, GA
Click here to add this to my saved trials
Atlanta, Georgia
Phone: 404-257-9000
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Baltimore, Maryland
Phone: 410-955-4916
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bedford, Texas 76022
Phone: 972-265-8201
?
mi
from
Bedford, TX
Click here to add this to my saved trials
Boston, Massachusetts
Phone: 617-667-3197
?
mi
from
Boston, MA
Click here to add this to my saved trials
Bridgeton, Missouri 63044
Phone: 314-770-1000
?
mi
from
Bridgeton, MO
Click here to add this to my saved trials
Brockton, Massachusetts 02301
Phone: 508-588-9900
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Brooklyn, New York 11215
Phone: 718-332-0600
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Chapel Hill, North Carolina
Phone: 919-966-6806
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
Chicago, Illinois
Phone: 773-702-0719
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
Phone: 619-585-8882
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
Clearwater, Florida 33756
Phone: 727-443-7700
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Columbia, South Carolina
Phone: 803-462-2300
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Creve Coeur, Missouri
Phone: 636-220-1200
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
Danbury, Connecticut 06810
Phone: 516-470-6901
?
mi
from
Danbury, CT
Click here to add this to my saved trials
Durham, North Carolina
Phone: 919-684-1817
?
mi
from
Durham, NC
Click here to add this to my saved trials
Edgewater, Florida
Phone: 386-428-7730
?
mi
from
Edgewater, FL
Click here to add this to my saved trials
Edmonton, Alberta
Phone: 780-244-8833
?
mi
from
Edmonton,
Click here to add this to my saved trials
Farmington Hills, Michigan 48334
Phone: 248-716-7012
?
mi
from
Farmington Hills, MI
Click here to add this to my saved trials
Fort Sam Houston, Texas 78234
Phone: 210-916-3879
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
Glen Burnie, Maryland 21061
Phone: 410-602-7782
?
mi
from
Glen Burnie, MD
Click here to add this to my saved trials
Great Neck, New York 11021
Phone: 516-466-1051
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
Greenville, South Carolina 29605
Phone: 864-232-7338
?
mi
from
Greenville, SC
Click here to add this to my saved trials
Hamden, Connecticut 06518
Phone: 203-281-5161
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Hartsdale, New York
Phone: 516-470-6901
?
mi
from
Hartsdale, NY
Click here to add this to my saved trials
Houston, Texas
Phone: 832-885-7723
?
mi
from
Houston, TX
Click here to add this to my saved trials
Huntsville, Alabama 35801
Phone: 256-536-6600
?
mi
from
Huntsville, AL
Click here to add this to my saved trials
Indianapolis, Indiana 46202
Phone: 317-944-3332
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
Jacksonville, Florida 32209
Phone: 904-680-0871
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
La Jolla, California 92093
Phone: 858-246-2353
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
Phone: 337-493-5310
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lakewood Ranch, Florida 34202
Phone: 941-894-2014
?
mi
from
Lakewood Ranch, FL
Click here to add this to my saved trials
Lancaster, California 93534
Phone: 661-388-2239
?
mi
from
Lancaster, CA
Click here to add this to my saved trials
Lebanon, New Hampshire
Phone: 603-650-5261
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Leesburg, Virginia
Phone: 703-723-3670
?
mi
from
Leesburg, VA
Click here to add this to my saved trials
Lexington, Kentucky
Phone: 859-323-1086
?
mi
from
Lexington, KY
Click here to add this to my saved trials
Long Beach, California 90806
Phone: 562-826-8000
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California
Phone: 310-282-0525
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Lynchburg, Virginia 24501
Phone: 434-455-8670
?
mi
from
Lynchburg, VA
Click here to add this to my saved trials
Madison, Wisconsin 53792
Phone: 608-263-1995
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
Phone: 678-819-4217
?
mi
from
Marietta, GA
Click here to add this to my saved trials
Metairie, Louisiana 70006
Phone: 504-456-8020
?
mi
from
Metairie, LA
Click here to add this to my saved trials
Miami, Florida 33136
Phone: 786-636-6695
?
mi
from
Miami, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53226
Phone: 414-908-6630
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Monroe, Louisiana
Phone: 318-283-2177
?
mi
from
Monroe, LA
Click here to add this to my saved trials
Mountain View, California 94040
Phone: 650-934-7000
?
mi
from
Mountain View, CA
Click here to add this to my saved trials
Naples, Florida 34102
Phone: 239-649-1336
?
mi
from
Naples, FL
Click here to add this to my saved trials
Nashville, Tennessee 37232
Phone: 615-322-0281
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New Hyde Park, New York 11040
Phone: 516-437-9000
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
New Orleans, Louisiana
Phone: 504-842-4015
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10032
Phone: 212-831-4900
?
mi
from
New York, NY
Click here to add this to my saved trials
North Little Rock, Arkansas
Phone: 501-945-9300
?
mi
from
North Little Rock, AR
Click here to add this to my saved trials
Ocala, Florida 34471
Phone: 352-401-1919
?
mi
from
Ocala, FL
Click here to add this to my saved trials
Ogden, Utah 84403
Phone: 801-409-2040
?
mi
from
Ogden, UT
Click here to add this to my saved trials
Oklahoma City, Oklahoma
Phone: 405-271-8001
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
Orlando, Florida 32804
Phone: 407-896-1726
?
mi
from
Orlando, FL
Click here to add this to my saved trials
Philadelphia, Pennsylvania
Phone: 215-762-8012
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
Phone: 602-288-4673
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Pompano Beach, Florida 33064
Phone: 954-946-8873
?
mi
from
Pompano Beach, FL
Click here to add this to my saved trials
Port Orange, Florida
Phone: 386-767-8800
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
Pratt, Kansas
Phone: 620-672-1234
?
mi
from
Pratt, KS
Click here to add this to my saved trials
Raleigh, North Carolina 27607
Phone: 919-781-2514
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Reno, Nevada 89502
Phone: 877-557-3732
?
mi
from
Reno, NV
Click here to add this to my saved trials
Reston, Virginia 20191
Phone: 919-830-4841
?
mi
from
Reston, VA
Click here to add this to my saved trials
Richmond, Virginia 23227
Phone: 804-628-3630
?
mi
from
Richmond, VA
Click here to add this to my saved trials
Rochester, Minnesota 55905
Phone: 507-284-2141
?
mi
from
Rochester, MN
Click here to add this to my saved trials
San Antonio, Texas 78224
Phone: 210-271-0606
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California
Phone: 858-277-5678
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Seattle, Washington 98105
Phone: 206-543-3500
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shreveport, Louisiana 71103
Phone: 318-525-3233
?
mi
from
Shreveport, LA
Click here to add this to my saved trials
Temple, Texas
Phone: 254-724-2111
?
mi
from
Temple, TX
Click here to add this to my saved trials
Wheat Ridge, Colorado 80033
Phone: 303-940-9773
?
mi
from
Wheat Ridge, CO
Click here to add this to my saved trials
Winston-Salem, North Carolina
Phone: 336-713-7312
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials