Clinical trial NCT03759041: A Study to Assess Efficacy and Safety of SER-287 in Adults With Active Mild-to-Moderate Ulcerative Colitis
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Ulcerative Colitis
Keywords: microbiome
Lead sponsor: Seres Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-29
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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).

Eligibility 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

Primary outcomes:
measure: Clinical Remission (Count of Participants)
timeFrame: After 10 weeks of induction dosing
Secondary outcomes:
measure: Endoscopic Improvement (Count of Participants)
timeFrame: After 10 weeks of induction dosing
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: (Investigator site)
state: Arizona
city: North Little Rock
country: United States
facility: (Investigator site)
state: Arkansas
city: La Jolla
country: United States
facility: (Investigator site)
state: California
city: Lancaster
country: United States
facility: (Investigator site)
state: California
city: Los Angeles
country: United States
facility: (Investigator site)
state: California
city: Mountain View
country: United States
facility: (Investigator site)
state: California
city: San Diego
country: United States
facility: (Investigator site)
state: California
city: San Diego
country: United States
facility: (Investigator site)
state: California
city: Wheat Ridge
country: United States
facility: (Investigator site)
state: Colorado
city: Danbury
country: United States
facility: (Investigator site)
state: Connecticut
city: Hamden
country: United States
facility: (Investigator site)
state: Connecticut
city: Boca Raton
country: United States
facility: (Investigator site)
state: Florida
city: Clearwater
country: United States
facility: (Investigator site)
state: Florida
city: Crystal River
country: United States
facility: (Investigator site)
state: Florida
city: Fort Lauderdale
country: United States
facility: (Investigator site)
state: Florida
city: Hialeah
country: United States
facility: (Investigator site)
state: Florida
city: Jacksonville
country: United States
facility: (Investigator site)
state: Florida
city: Miami
country: United States
facility: (Investigator site)
state: Florida
city: Miami
country: United States
facility: (Investigator site)
state: Florida
city: Naples
country: United States
facility: (Investigator site)
state: Florida
city: Ocala
country: United States
facility: (Investigator site)
state: Florida
city: Orlando
country: United States
facility: (Investigator site)
state: Florida
city: Pompano Beach
country: United States
facility: (Investigator site)
state: Florida
city: Port Orange
country: United States
facility: (Investigator site)
state: Florida
city: Tampa
country: United States
facility: (Investigator site)
state: Florida
city: Athens
country: United States
facility: (Investigator site)
state: Georgia
city: Atlanta
country: United States
facility: (Investigator site)
state: Georgia
city: Marietta
country: United States
facility: (Investigator site)
state: Georgia
city: Chicago
country: United States
facility: (Investigator site)
state: Illinois
city: Chicago
country: United States
facility: (Investigator site)
state: Illinois
city: Chicago
country: United States
facility: (Investigator site)
state: Illinois
city: Indianapolis
country: United States
facility: (Investigator site)
state: Indiana
city: Lexington
country: United States
facility: (Investigator site)
state: Kentucky
city: Lake Charles
country: United States
facility: (Investigator site)
state: Louisiana
city: Metairie
country: United States
facility: (Investigator site)
state: Louisiana
city: Monroe
country: United States
facility: (Investigator site)
state: Louisiana
city: New Orleans
country: United States
facility: (Investigator site)
state: Louisiana
city: Shreveport
country: United States
facility: (Investigator site)
state: Louisiana
city: Baltimore
country: United States
facility: (Investigator site)
state: Maryland
city: Glen Burnie
country: United States
facility: (Investigator site)
state: Maryland
city: Ann Arbor
country: United States
facility: (Investigator site)
state: Michigan
city: Farmington Hills
country: United States
facility: (Investigator site)
state: Michigan
city: Rochester
country: United States
facility: (Investigator site)
state: Minnesota
city: Bridgeton
country: United States
facility: (Investigator site)
state: Missouri
city: Creve Coeur
country: United States
facility: (Investigator site)
state: Missouri
city: Las Vegas
country: United States
facility: (Investigator site)
state: Nevada
city: Reno
country: United States
facility: (Investigator site)
state: Nevada
city: Lebanon
country: United States
facility: (Investigator site)
state: New Hampshire
city: Great Neck
country: United States
facility: (Investigator site)
state: New York
city: Hartsdale
country: United States
facility: (Investigator site)
state: New York
city: New York
country: United States
facility: (Investigator site)
state: New York
city: New York
country: United States
facility: (Investigator site)
state: New York
city: Asheville
country: United States
facility: (Investigator site)
state: North Carolina
city: Chapel Hill
country: United States
facility: (Investigator site)
state: North Carolina
city: Durham
country: United States
facility: (Investigator site)
state: North Carolina
city: Raleigh
country: United States
facility: (Investigator site)
state: North Carolina
city: Winston-Salem
country: United States
facility: (Investigator site)
state: North Carolina
city: Winston-Salem
country: United States
facility: (Investigator site)
state: North Carolina
city: Cincinnati
country: United States
facility: (Investigator site)
state: Ohio
city: Oklahoma City
country: United States
facility: (Investigator site)
state: Oklahoma
city: Columbia
country: United States
facility: (Investigator site)
state: South Carolina
city: Greenville
country: United States
facility: (Investigator site)
state: South Carolina
city: Memphis
country: United States
facility: (Investigator site)
state: Tennessee
city: Nashville
country: United States
facility: (Investigator site)
state: Tennessee
city: Bedford
country: United States
facility: (Investigator site)
state: Texas
city: Fort Sam Houston
country: United States
facility: (Investigator site)
state: Texas
city: Houston
country: United States
facility: (Investigator site)
state: Texas
city: Houston
country: United States
facility: (Investigator site)
state: Texas
city: Houston
country: United States
facility: (Investigator site)
state: Texas
city: McAllen
country: United States
facility: (Investigator site)
state: Texas
city: San Antonio
country: United States
facility: (Investigator site)
state: Texas
city: Temple
country: United States
facility: (Investigator site)
state: Texas
city: Ogden
country: United States
facility: (Investigator site)
state: Utah
city: Salt Lake City
country: United States
facility: (Investigator site)
state: Utah
city: Leesburg
country: United States
facility: (Investigator site)
state: Virginia
city: Lynchburg
country: United States
facility: (Investigator site)
state: Virginia
city: Reston
country: United States
facility: (Investigator site)
state: Virginia
city: Richmond
country: United States
facility: (Investigator site)
state: Virginia
city: Spokane
country: United States
facility: (Investigator site)
state: Washington
city: Madison
country: United States
facility: (Investigator site)
state: Wisconsin
city: Milwaukee
country: United States
facility: (Investigator site)
state: Wisconsin
city: Edmonton
country: Canada
facility: (Investigator site)
state: Alberta
city: Edmonton
country: Canada
facility: (Investigator site)
state: Alberta
city: New Westminster
country: Canada
facility: (Investigator site)
state: British Columbia
city: Bridgewater
country: Canada
facility: (Investigator site)
state: Ontario
city: Lindsay
country: Canada
facility: (Investigator site)
state: Ontario
city: London
country: Canada
facility: (Investigator site)
state: Ontario
city: London
country: Canada
facility: (Investigator site)
state: Ontario
city: Sudbury
country: Canada
facility: (Investigator site)
state: Ontario
city: Toronto
country: Canada
facility: (Investigator site)
state: Ontario
city: Vaughan
country: Canada
facility: (Investigator site)
state: Ontario
city: Greenfield Park
country: Canada
facility: (Investigator site)
state: Quebec
city: Saskatoon
country: Canada
facility: (Investigator site)
state: Saskatchewan
Study officials:
affiliation: Seres Therapeutics, Inc.
name: Lisa von Moltke, MD
role: STUDY_DIRECTOR
References: