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A Study to Assess Efficacy and Safety of SER‑287 in Adults With Active Mild-to-Moderate Ulcerative Colitis (ECO-RESET)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03759041
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Vancomycin Pre-Treatment Drug: Placebo for Vancomycin Pre-Treatment Drug: SER-287 Drug: Placebo for SER-287 Phase 2

Detailed Description:
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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 19, 2018
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Vancomycin

Arm Intervention/treatment
Placebo Comparator: Placebo (after placebo pre-treat.)
Once-daily dosing of Placebo (after placebo pre-treatment)
Drug: Placebo for Vancomycin Pre-Treatment
Four times per day dosing of placebo pre-treatment

Drug: Placebo for SER-287
Once-daily dosing of Placebo for SER-287

Experimental: SER-287 Induction Dosing (after vanco. pre-treat.)
Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
Drug: Vancomycin Pre-Treatment
Four times per day dosing of vancomycin pre-treatment

Drug: SER-287
Once-daily dosing of SER-287
Other Name: Eubacterial Spores, Purified Suspension, Encapsulated

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: SER-287
Once-daily dosing of SER-287
Other Name: Eubacterial Spores, Purified Suspension, Encapsulated




Primary Outcome Measures :
  1. Clinical Remission [ Time Frame: After 10 weeks of induction dosing ]

Secondary Outcome Measures :
  1. Endoscopic Improvement [ Time Frame: After 10 weeks of induction dosing ]
    Endoscopic subscore (modified Mayo Score) decrease from baseline of at least one point



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759041


Contacts
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Contact: Sherry Weigand, MD, PhD 617-203-3492 clinicalstudies@serestherapeutics.com
Contact: https://www.eco-resetstudy.com/#!/

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Locations
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United States, Arizona
(Investigator site) Recruiting
Phoenix, Arizona, United States, 85018
Contact    602-288-4673      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Arkansas
(Investigator site) Recruiting
North Little Rock, Arkansas, United States, 72117
Contact    501-945-9300      
Contact: https://www.eco-resetstudy.com/#!/         
United States, California
(Investigator site) Recruiting
Chula Vista, California, United States, 91910
Contact    619-585-8882      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
La Jolla, California, United States, 92037
Contact    858-246-2353      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Lancaster, California, United States, 93534
Contact    661-388-2239      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Los Angeles, California, United States, 90032
Contact    323-442-5100      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Los Angeles, California, United States, 90067
Contact    310-282-0525      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Mountain View, California, United States, 94040
Contact    650-934-7000      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
San Diego, California, United States, 92103
Contact    619-260-1012      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
San Diego, California, United States, 92123
Contact    858-277-5678      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Colorado
(Investigator site) Recruiting
Wheat Ridge, Colorado, United States, 80033
Contact    303-940-9773      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Connecticut
(Investigator site) Recruiting
Danbury, Connecticut, United States, 06810
Contact    203-739-4860      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Hamden, Connecticut, United States, 06518
Contact    203-281-5161      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Florida
(Investigator site) Recruiting
Boca Raton, Florida, United States, 33487
Contact    561-495-5700      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Clearwater, Florida, United States, 33762
Contact    727-443-7700      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Crystal River, Florida, United States, 34429
Contact    352-341-2100      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Edgewater, Florida, United States, 32132
Contact    386-428-7730      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Fort Lauderdale, Florida, United States, 33308
Contact    954-938-2843      
Contact: https://www.eco-resetstudy.com/         
(Investigator site) Recruiting
Hialeah, Florida, United States, 33012
Contact    786-483-7856      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Jacksonville, Florida, United States, 32256
Contact    904-680-0871      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Lakewood Ranch, Florida, United States, 34211
Contact    941-727-7772      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Miami, Florida, United States, 33136
Contact    305-243-8644      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Miami, Florida, United States, 33176
Contact    786-636-6695      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Naples, Florida, United States, 34102
Contact    239-649-1336      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Naples, Florida, United States, 34102
Contact    239-631-2989      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Ocala, Florida, United States, 34474
Contact    352-401-1919      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Orlando, Florida, United States, 32803
Contact    407-896-1726      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Pompano Beach, Florida, United States, 33060
Contact    954-946-8873      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Port Orange, Florida, United States, 32127
Contact    386-767-8800      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Tampa, Florida, United States, 33609
Contact    813-240-9734      
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United States, Georgia
(Investigator site) Recruiting
Athens, Georgia, United States, 30607
Contact    706-461-5454      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-3184      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Marietta, Georgia, United States, 30060
Contact    678-819-4217      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Illinois
(Investigator site) Not yet recruiting
Chicago, Illinois, United States, 60611
Contact    312-695-4929      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Chicago, Illinois, United States, 60612
Contact    312-942-5861      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Chicago, Illinois, United States, 60637
Contact    773-702-0719      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Indiana
(Investigator site) Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-944-3332      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Kansas
(Investigator site) Recruiting
Pratt, Kansas, United States, 67124
Contact    620-672-1234      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Kentucky
(Investigator site) Recruiting
Lexington, Kentucky, United States, 40536
Contact    859-323-1086      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Louisiana
(Investigator site) Recruiting
Lake Charles, Louisiana, United States, 70601
Contact    337-493-5310      
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(Investigator site) Recruiting
Metairie, Louisiana, United States, 70006
Contact    504-456-8020      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Monroe, Louisiana, United States, 71201
Contact    318-283-2177      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New Orleans, Louisiana, United States, 70115
Contact    504-905-3260      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New Orleans, Louisiana, United States, 70121
Contact    504-842-4015      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Shreveport, Louisiana, United States, 71105
Contact    318-525-3233      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Maryland
(Investigator site) Recruiting
Baltimore, Maryland, United States, 21287
Contact    410-955-4916      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Glen Burnie, Maryland, United States, 21208
Contact    410-602-7782      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Michigan
(Investigator site) Recruiting
Ann Arbor, Michigan, United States, 48109
Contact    734-647-2964      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Farmington Hills, Michigan, United States, 48334
Contact    248-716-7012      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Minnesota
(Investigator site) Recruiting
Rochester, Minnesota, United States, 55905
Contact    507-284-2141      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Missouri
(Investigator site) Recruiting
Bridgeton, Missouri, United States, 63044
Contact    314-770-1000      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Creve Coeur, Missouri, United States, 63141
Contact    636-220-1200      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Nevada
(Investigator site) Recruiting
Las Vegas, Nevada, United States, 89123
Contact    702-898-2088      
Contact: https://www.eco-resetstudy.com/         
(Investigator site) Recruiting
Reno, Nevada, United States, 89511
Contact    877-557-3732      
Contact: https://www.eco-resetstudy.com/#!/         
United States, New Hampshire
(Investigator site) Recruiting
Lebanon, New Hampshire, United States, 03756
Contact    603-650-5261      
Contact: https://www.eco-resetstudy.com/#!/         
United States, New York
(Investigator site) Recruiting
Brooklyn, New York, United States, 11235
Contact    718-332-0600      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Great Neck, New York, United States, 11021
Contact    516-466-1051      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Hartsdale, New York, United States, 10530
Contact    914-341-2346      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New Hyde Park, New York, United States, 11040
Contact    516-437-9000      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New York, New York, United States, 10016
Contact    212-889-5544      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New York, New York, United States, 10016
Contact    212-263-3095      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
New York, New York, United States, 10032
Contact    212-831-4900      
Contact: https://www.eco-resetstudy.com/#!/         
United States, North Carolina
(Investigator site) Recruiting
Asheville, North Carolina, United States, 28801
Contact    828-254-0881      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact    919-966-6806      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Durham, North Carolina, United States, 27710
Contact    919-684-1817      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Raleigh, North Carolina, United States, 27612
Contact    919-781-2514      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact    336-768-8062      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Winston-Salem, North Carolina, United States, 27157
Contact    336-713-7312      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Ohio
(Investigator site) Recruiting
Cincinnati, Ohio, United States, 45219
Contact    513-872-4549      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Oklahoma
(Investigator site) Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact    405-271-5428      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact    405-702-1246      
Contact: https://www.eco-resetstudy.com/#!/         
United States, South Carolina
(Investigator site) Recruiting
Columbia, South Carolina, United States, 29203
Contact    803-462-2300      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Greenville, South Carolina, United States, 29615
Contact    864-232-7338      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Tennessee
(Investigator site) Not yet recruiting
Memphis, Tennessee, United States, 38119
Contact    901-682-6540      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Nashville, Tennessee, United States, 37212
Contact    615-322-0281      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Texas
(Investigator site) Recruiting
Bedford, Texas, United States, 76022
Contact    972-265-8201      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Fort Sam Houston, Texas, United States, 78219
Contact    210-916-3879      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Not yet recruiting
Houston, Texas, United States, 77030
Contact    713-441-0006      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Houston, Texas, United States, 77036
Contact    713-777-2776      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Houston, Texas, United States, 77043
Contact    281-768-5879      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Houston, Texas, United States, 77090
Contact    832-885-7723      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
McAllen, Texas, United States, 78504
Contact    956-584-9000      
Contact: https://www.eco-resetstudy.com/         
(Investigator site) Recruiting
San Antonio, Texas, United States, 78229
Contact    210-271-0606      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Temple, Texas, United States, 76508
Contact    254-724-2111      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Utah
(Investigator site) Recruiting
Ogden, Utah, United States, 84405
Contact    801-409-2040      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Salt Lake City, Utah, United States, 84124
Contact    801-263-3041      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Virginia
(Investigator site) Recruiting
Leesburg, Virginia, United States, 20176
Contact    703-723-3670      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Lynchburg, Virginia, United States, 24502
Contact    434-455-8670      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Reston, Virginia, United States, 20191
Contact    919-830-4841      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Richmond, Virginia, United States, 23249
Contact    804-628-3630      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Washington
(Investigator site) Not yet recruiting
Seattle, Washington, United States, 98195
Contact    206-543-3500      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Spokane, Washington, United States, 99202
Contact    509-456-5433      
Contact: https://www.eco-resetstudy.com/#!/         
United States, Wisconsin
(Investigator site) Recruiting
Madison, Wisconsin, United States, 53792
Contact    608-263-1995      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact    414-908-6630      
Contact: https://www.eco-resetstudy.com/#!/         
Canada, Alberta
(Investigator site) Not yet recruiting
Edmonton, Alberta, Canada, T6G 2L7
Contact    780-492-8307      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Edmonton, Alberta, Canada, T6L 6K3
Contact    780-244-8833      
Contact: https://www.eco-resetstudy.com/#!/         
Canada, British Columbia
(Investigator site) Recruiting
New Westminster, British Columbia, Canada, V3L 3W4
Contact    604-521-4500      
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Canada, Ontario
(Investigator site) Recruiting
Bridgewater, Ontario, Canada, B4V 3K9
Contact    902-530-3512      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Lindsay, Ontario, Canada, K9V 5G6
Contact    705-878-5200      
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(Investigator site) Recruiting
London, Ontario, Canada, N6A 5A5
Contact    519-685-8500      
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(Investigator site) Recruiting
London, Ontario, Canada, N6A 5W9
Contact    519-685-8500      
Contact: https://www.eco-resetstudy.com/#!/         
(Investigator site) Recruiting
Sudbury, Ontario, Canada, P3C 5K6
Contact    519-624-8589      
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(Investigator site) Not yet recruiting
Toronto, Ontario, Canada, M5T 3A9
Contact    416-928-9511      
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(Investigator site) Recruiting
Vaughan, Ontario, Canada, L4L 4Y7
Contact    416-650-0017      
Contact: https://www.eco-resetstudy.com/#!/         
Canada, Quebec
(Investigator site) Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2H1
Contact    450-466-5000      
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Canada, Saskatchewan
(Investigator site) Recruiting
Saskatoon, Saskatchewan, Canada, S7N 0W8
Contact    306-844-1002      
Contact: https://www.eco-resetstudy.com/#!/         
Sponsors and Collaborators
Seres Therapeutics, Inc.
Investigators
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Study Director: Sherry Weigand, MD, PhD Seres Therapeutics, Inc.

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Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03759041     History of Changes
Other Study ID Numbers: SERES-201
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Seres Therapeutics, Inc.:
microbiome
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents