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
Oklahoma City, Oklahoma
Phone: 405-271-8001
?
mi
from
Oklahoma City, OK
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
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
Salt Lake City, Utah
Phone: 801-263-3041
?
mi
from
Salt Lake City, UT
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