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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Ulcerative Colitis

Intervention / Treatment
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* Drug: Vancomycin Pre-Treatment
* Drug: Placebo for Vancomycin Pre-Treatment
* Drug: SER-287
* Drug: Placebo for SER-287


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo (after placebo pre-treatment)<br>Once-daily dosing of Placebo (after placebo pre-treatment) | Drug: Placebo for Vancomycin Pre-Treatment<br>* Four times per day dosing of placebo pre-treatment<br>Drug: Placebo for SER-287<br>* Once-daily dosing of Placebo for SER-287<br>|
| Experimental: SER-287 Induction Dosing (after vancomycin pre-treatment)<br>Once-daily dosing of SER-287 (Induction Dose, after vancomycin pre-treatment) | Drug: Vancomycin Pre-Treatment<br>* Four times per day dosing of vancomycin pre-treatment<br>Drug: SER-287<br>* Once-daily dosing of SER-287<br>* Other names: Eubacterial Spores, Purified Suspension, Encapsulated;|
| Experimental: SER-287 Step-Down Induction Dosing (after vancomycin pre-treatment)<br>Once-daily dosing of SER-287 (Step-Down Induction Dose, after vancomycin pre-treatment) | Drug: Vancomycin Pre-Treatment<br>* Four times per day dosing of vancomycin pre-treatment<br>Drug: SER-287<br>* Once-daily dosing of SER-287<br>* Other names: Eubacterial Spores, Purified Suspension, Encapsulated;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Remission (Count of Participants) | 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. | After 10 weeks of induction dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic Improvement (Count of Participants) | 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. | After 10 weeks of induction dosing | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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microbiome