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

Phase 2

Terminated

• Conditions: Ulcerative Colitis
• Interventions: Drug: Vancomycin Pre-Treatment; Drug: Placebo for Vancomycin Pre-Treatment; Drug: Placebo for SER-287; Drug: SER-287

• Registration Number: NCT03759041
• Lead Sponsor: 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

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).

Study Timeline

• Study First Submitted: 2018-11-27
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2018-12-19
• Primary Completion: 2021-05-28
• Study Completion: 2021-10-13
• Results First Submitted: 2022-05-24
• Results First Submitted QC: 2022-05-24
• Results First Posted: 2022-06-21
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-08-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 203

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)	Vancomycin Pre-Treatment	Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)
Placebo (after placebo pre-treatment)	Placebo for Vancomycin Pre-Treatment	Once-daily dosing of Placebo (after placebo pre-treatment)
Placebo (after placebo pre-treatment)	Placebo for SER-287	Once-daily dosing of Placebo (after placebo pre-treatment)
SER-287 Induction Dosing (after vancomycin pre-treatment)	Vancomycin Pre-Treatment	Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
SER-287 Induction Dosing (after vancomycin pre-treatment)	SER-287	Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment)
SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)	SER-287	Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment)

Primary Outcome Measures

Name	Time	Method
Clinical Remission (Count of Participants)	After 10 weeks of induction dosing	Clinical remission for the induction treatment period: * Stool Frequency subscore = 0 or 1, with at least 1-point decrease from baseline; * Rectal Bleeding subscore = 0; * Endoscopic subscore = 0 or 1 on modified Mayo Score, with at least 1-point decrease from baseline; * No occurrence of UC Flare during the treatment period; Clinical remission was measured using 3 components of the modified Mayo Score (stool frequency, rectal bleeding and endoscopic subscore), a measure of UC disease activity. These 3 components are each graded from 0 to 3, and are summed together for a composite score, with a higher overall score indicating more severe disease (0 = no disease; 9 = worst disease). The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.

Secondary Outcome Measures

Name	Time	Method
Endoscopic Improvement (Count of Participants)	After 10 weeks of induction dosing	Endoscopic subscore decrease from baseline of at least 1 point, as assessed by flexible sigmoidoscopy or colonoscopy.; Endoscopic improvement was measured using the modified Mayo Score endoscopic subscore, graded from 0 to 3, with higher scores indicating more severe disease. The modified Mayo endoscopic subscore excludes friability from an endoscopic subscore of 1.

Trial Locations

Locations (1)

(Investigator site); 🇨🇦 Saskatoon, Saskatchewan, Canada