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
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
203
Four times per day dosing of vancomycin pre-treatment
Four times per day dosing of placebo pre-treatment
Once-daily dosing of SER-287
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.
Time frame: After 10 weeks of induction dosing
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.
Time frame: After 10 weeks of induction dosing
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Once-daily dosing of Placebo for SER-287
(Investigator site)
Phoenix, Arizona, United States
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North Little Rock, Arkansas, United States
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La Jolla, California, United States
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Lancaster, California, United States
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Los Angeles, California, United States
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Mountain View, California, United States
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San Diego, California, United States
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San Diego, California, United States
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Wheat Ridge, Colorado, United States
(Investigator site)
Danbury, Connecticut, United States
...and 83 more locations