NCT02618187

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2016

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2015

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 1, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 13, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

June 20, 2019

Completed
Last Updated

June 20, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

November 20, 2015

Results QC Date

September 25, 2018

Last Update Submit

March 20, 2019

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (3)

  • Safety and Tolerability of SER-287

    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.

    Day 246

  • Composition of the Intestinal Microbiome

    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.

    Baseline and 8 weeks

  • Engraftment of SER-287 Bacteria in All Treatment Arms

    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.

    Baseline and 8 weeks

Secondary Outcomes (2)

  • Clinical Remission

    8 weeks

  • Endoscopic Improvement

    8 weeks

Study Arms (4)

Weekly SER-287, after Placebo Pre-Treat.

EXPERIMENTAL

Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Drug: SER-287Drug: Placebo Pre-Treat

Daily placebo, after Placebo Pre-Treat.

PLACEBO COMPARATOR

Placebo pre-treatment, followed by once daily placebo for 8 weeks

Drug: PlaceboDrug: Placebo Pre-Treat

Daily SER-287, after Vanco. Pre-Treat.

EXPERIMENTAL

Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks

Drug: SER-287Drug: Vancomycin Pre-Treat

Weekly SER-287, after Vanco. Pre-Treat.

EXPERIMENTAL

Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks

Drug: SER-287Drug: Vancomycin Pre-Treat

Interventions

SER-287DRUG
Also known as: Eubacterial Spores, Purified Suspension, Encapsulated
Daily SER-287, after Vanco. Pre-Treat.Weekly SER-287, after Placebo Pre-Treat.Weekly SER-287, after Vanco. Pre-Treat.
PlaceboDRUG
Daily placebo, after Placebo Pre-Treat.
Placebo Pre-TreatDRUG
Daily placebo, after Placebo Pre-Treat.Weekly SER-287, after Placebo Pre-Treat.
Vancomycin Pre-TreatDRUG
Daily SER-287, after Vanco. Pre-Treat.Weekly SER-287, after Vanco. Pre-Treat.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 sigmoidoscopy within approximately 3 days of randomization to study

You may not qualify if:

  • Fever \> 38.3°C
  • Known or suspected toxic megacolon and/or known small bowel ileus
  • Known history of Crohn's disease
  • Subjects with serum albumin \<2.5 g/dL at baseline
  • CMV polymerase chain reaction (PCR) positive from blood plasma at screening
  • Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment
  • Subjects on cyclosporine or triple immunosuppression, Triple immunosuppression will include any three of the following classes of drugs taken in combination: steroids (i.e., prednisone/budesonide/budesonide MMX), immunosuppressant (i.e., methotrexate/azathioprine/6-mercaptopurine), and/or other immunosuppressant (i.e., tacrolimus, cellcept).
  • Biologic medication (infliximab/ adalimumab/ golimumab/ certolizumab/vedolizumab/ustekinumab/natalizumab) use within 3 months prior to screening
  • Known active malignancy except for basal cell skin cancer, squamous cell skin cancer
  • Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)
  • Subjects with known history of celiac disease or gluten enteropathy
  • Subjects with Clostridium difficile positive stool at Screening Visit
  • Antibiotic use within the prior 1 month before randomization
  • Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
  • Received an investigational drug within 1 month before study entry
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Community Clinical Research Network

Marlborough, Massachusetts, 01752, United States

Location

Related Publications (1)

  • 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.

    PMID: 32763240DERIVED

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Results Point of Contact

Title
Dr. Michele Trucksis, Chief Medical Officer
Organization
Seres Therapeutics
mtrucksis@serestherapeutics.com
617-945-9626

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2015

First Posted

December 1, 2015

Study Start

January 13, 2016

Primary Completion

December 6, 2017

Study Completion

January 26, 2018

Last Updated

June 20, 2019

Results First Posted

June 20, 2019

Record last verified: 2019-03

Locations

US(1)