Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02618187 | A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis | PHASE1 | COMPLETED | 58 | — | — | Jan 13, 2016 | Jan 26, 2018 | Jun 20, 2019 | 1 | United States |
Treatment-Emergent Adverse Events Incidence by Treatment, System Organ Class and Preferred Term. The treatment period with SER-287 was eight weeks. All AEs were collected from the date of Informed Consent (up to 17 days of Screening) through Day 92 of the study. All SAEs were collected from the date of Informed Consent through Day 246 of the study.
Changes in the composition of the microbiome were characterized by whole metagenomic sequencing (WMS) of subjects' stool samples. Changes in the composition of the microbiome were measured by quantifying the number of unique types of spore-forming bacteria detected in subjects' stool samples after eight weeks of induction treatment versus baseline.
The stool microbiomes of SERES-101 subjects, before and after treatment with SER-287, were characterized using whole metagenomic sequencing (WMS). SER-287 drug product was also characterized using WMS. Microbiome engraftment was assessed by the number of spore-forming species in the drug product lots that were also detected in subjects' post-treatment fecal samples but not detected at baseline.
| Arm | Type | Description |
|---|---|---|
| Weekly SER-287, after Placebo Pre-Treat. | EXPERIMENTAL | Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks |
| Daily placebo, after Placebo Pre-Treat. | PLACEBO_COMPARATOR | Placebo pre-treatment, followed by once daily placebo for 8 weeks |
| Daily SER-287, after Vanco. Pre-Treat. | EXPERIMENTAL | Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks |
| Weekly SER-287, after Vanco. Pre-Treat. | EXPERIMENTAL | Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks |
| Name | Type | Description |
|---|---|---|
| SER-287 | DRUG | - |
| Placebo | DRUG | - |
| Placebo Pre-Treat | DRUG | - |
| Vancomycin Pre-Treat | DRUG | - |
Inclusion Criteria: * Ulcerative colitis diagnosed by routine clinical, radiographic, endoscopic and pathologic criteria (preferably confirmed by colonoscopy and pathology records within last 2 years or if unavailable, will need approval by medical monitor) Active mild-moderate UC as determined by ...