drugset / Trial / NCT02618187

A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

Phase 1 Completed 58 enrolled Seres Therapeutics, Inc.

RandomizedParallel-groupDouble-blindTreatment

Summary

A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Timeline

Start: 2016-01-13
Primary completion: 2017-12-06
Completion: 2018-01-26

Outcome

Mixed primary results

registry analysis (superiority test); Daily Placebo, After Placebo Pre-Treat. vs Daily SER-287, After Vanco. Pre-Treat.; p = 0.001; Wilcoxon (Mann-Whitney) NCT02618187 ↗

registry MEAN Daily Placebo, After Placebo Pre-Treat.: 4.333 (Standard Deviation 1.862) Richness SER-287 spore-forming species NCT02618187 ↗

registry MEAN Daily SER-287, After Vanco. Pre-Treat.: 16.7 (Standard Deviation 7.469) Richness SER-287 spore-forming species NCT02618187 ↗

registry analysis (superiority test); Weekly SER-287, After Placebo Pre-Treat. vs Daily Placebo, After Placebo Pre-Treat.; p = 0.257; Wilcoxon (Mann-Whitney) NCT02618187 ↗

registry MEAN Weekly SER-287, After Placebo Pre-Treat.: 7.222 (Standard Deviation 5.974) Richness SER-287 spore-forming species NCT02618187 ↗

Publications

Henn MR, O'Brien EJ, Diao L, Feagan BG, Sandborn WJ, Huttenhower C, Wortman JR, McGovern BH, Wang-Weigand S, Lichter DI, Chafee M, Ford CB, Bernardo P, Zhao P, Simmons S, Tomlinson AD, Cook DN, Pomerantz RJ, Misra BK, Aunins JG, Trucksis M. A Phase 1b Safety Study of SER-287, a Spore-Based Microbiome Therapeutic, for Active Mild to Moderate Ulcerative Colitis. Gastroenterology. 2021 Jan;160(1):115-127.e30. doi: 10.1053/j.gastro.2020.07.048. Epub 2020 Aug 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SER-287	Other / unclassified	—	Oral
Subject	Vancomycin	Other / unclassified	125 mg	Oral