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

Seres Therapeutics

Status and phase: Terminated; Phase 2

Conditions: Ulcerative Colitis

Treatments: Drug: Vancomycin Pre-Treatment; Drug: Placebo for Vancomycin Pre-Treatment; Drug: Placebo for SER-287; Drug: SER-287

Study type: Interventional

Funder types: Industry

Identifiers

NCT03759041

SERES-201

Details and patient eligibility

About

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

Full 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).

Enrollment: 203 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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203 participants in 3 patient groups, including a placebo group

Placebo (after placebo pre-treatment)

Placebo Comparator group

Description:

Once-daily dosing of Placebo (after placebo pre-treatment)

Treatment:

Drug: Placebo for Vancomycin Pre-Treatment

Drug: Placebo for SER-287

SER-287 Induction Dosing (after vancomycin pre-treatment)

Experimental group

Description:

Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)

Treatment:

Drug: SER-287

Drug: Vancomycin Pre-Treatment

SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)

Experimental group

Description:

Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)

Treatment:

Drug: SER-287

Drug: Vancomycin Pre-Treatment