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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)

S

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

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

Trial documents
3

Trial contacts and locations

93

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Data sourced from clinicaltrials.gov

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