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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Seres Therapeutics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02618187
First received: November 20, 2015
Last updated: September 2, 2016
Last verified: September 2016
  Purpose
A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.

Condition Intervention Phase
Ulcerative Colitis
Drug: Eubacterial Spores, Purified Suspension, Encapsulated
Drug: Placebo
Drug: Placebo Pre-Treat
Drug: Vancomycin Pre-Treat
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1B Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Seres Therapeutics, Inc.:

Primary Outcome Measures:
  • Safety and tolerability of SER-287 vs. placebo in adult subjects by analysis of AE's, lab values, vital sign, physical exam findings, medical history, and ECG. [ Time Frame: Day 246 ]
  • Examination of baseline composition of the intestinal microbiome to the composition [ Time Frame: 8 weeks ]
    Changes in the composition of the microbiome will be characterized by rDNA 16S V4 genomic data sets. Changes will be assessed by total number of unique bacteria and microbial composition

  • Engraftment of SER-287 bacteria into the intestinal microbial community in each of the SER-287 arms compared to the placebo arm [ Time Frame: 8 weeks ]
    Microbiome will be characterized by rDNA 16S v4 Genomic Data Sets. Engraftment will be assessed as the outgrowth of bacteria that compromise the SER-287 spore ecology in the subjects GI tract post treatment


Estimated Enrollment: 55
Study Start Date: December 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Placebo Pre-Treat + Weekly Drug
Placebo pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Drug: Eubacterial Spores, Purified Suspension, Encapsulated
Other Name: SER-287
Drug: Placebo Pre-Treat
Placebo Comparator: Placebo Pre-Treat + Daily placebo
Placebo pre-treatment, followed by once daily placebo for 8 weeks
Drug: Placebo Drug: Placebo Pre-Treat
Experimental: Antibiotic Pre-Treat + Daily Drug
Vancomycin pre-treatment, followed by once daily dosing of SER-287 for 8 weeks
Drug: Eubacterial Spores, Purified Suspension, Encapsulated
Other Name: SER-287
Drug: Vancomycin Pre-Treat
Experimental: Anitibiotic Pre-Treat + Weekly Drug
Vancomycin pre-treatment, followed by once weekly dosing of SER-287 for 8 weeks
Drug: Eubacterial Spores, Purified Suspension, Encapsulated
Other Name: SER-287
Drug: Vancomycin Pre-Treat

Detailed Description:
This is a Phase 1b multicenter, randomized, double-blind, placebo-controlled multiple dose study designed to evaluate the safety and tolerability of SER-287, and to evaluate the microbiome alterations and pharmacodynamics associated with 2 dosing regimens of SER-287 in adult subjects with mild-to-moderate ulcerative colitis (UC).
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 sigmoidoscopy within approximately 3 days of randomization to study

Exclusion Criteria:

  1. Fever > 38.3°C
  2. Known or suspected toxic megacolon and/or known small bowel ileus
  3. Known history of Crohn's disease
  4. Subjects with serum albumin <2.5 g/dL at baseline
  5. CMV polymerase chain reaction (PCR) positive from blood plasma at screening
  6. Known stool studies positive for ova and/or parasites or stool culture within the 30 days before enrollment
  7. 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).
  8. Biologic medication (infliximab/ adalimumab/ golimumab/ certolizumab/vedolizumab/ustekinumab/natalizumab) use within 3 months prior to screening
  9. Known active malignancy except for basal cell skin cancer, squamous cell skin cancer
  10. Subjects with previous colectomy, ostomy, J-pouch, or previous intestinal surgery (excluding cholecystectomy, appendectomy)
  11. Subjects with known history of celiac disease or gluten enteropathy
  12. Subjects with Clostridium difficile positive stool at Screening Visit
  13. Antibiotic use within the prior 1 month before randomization
  14. Expected to receive antibiotics within 8 weeks of signing the Informed Consent Form (ICF) (i.e., for planned/anticipated procedure)
  15. Received an investigational drug within 1 month before study entry
  16. Received an investigational antibody or vaccine within 3 months before study entry
  17. Previously enrolled in a SER-109/SER-287 study
  18. Received an FMT within the last 6 months
  19. Subjects with anatomic or medical contraindications to flexible sigmoidoscopy, including but not necessarily limited to toxic megacolon, gastrointestinal (GI) fistulas, immediate post-operative status from abdominal surgery, severe coagulopathy, large or symptomatic abdominal aortic aneurysm, or any subject where study physician deems subject at significant risk of complications of flexible sigmoidoscopy
  20. Unable to stop steroid enemas or suppositories or mesalamine enemas or suppositories before screening visit
  21. Unable to stop opiate treatment unless on a stable dose and no increase in dose planned for the duration of the study
  22. Unable to stop probiotics before screening visit
  23. Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with medical monitor)
  24. Known allergy or intolerance to oral vancomycin

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02618187

Contacts
Contact: Michele Trucksis, PhD, MD clinicalstudies@serestherapeutics.com

Locations
United States, California
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Contact: Darlene Romo    909-586-6243    dromo@ieliverfoundation.com   
Principal Investigator: Zeid Kayali         
United States, Florida
Consultants for Clinical Research Recruiting
Boynton Beach, Florida, United States, 33426
Contact: MaryLu Wells    561-732-9722    mwells@ccrstudy.com   
Principal Investigator: Madeline DuPree, MD         
Borland-Groover Clinic Recruiting
Jacksonville, Florida, United States, 32216
Contact: Marc Lojacono    904-383-1177    mlojacono01@bgclinic.com   
Principal Investigator: Bharat Misra, MD         
University of Miami Hospital Gastroenterology Recruiting
Miami, Florida, United States, 33138
Contact: Diana Morillo    305-243-6405    dmorillo@med.miami.edu   
Principal Investigator: David Kerman, MD         
Advanced Gastroenterology Ctr Recruiting
Port Orange, Florida, United States, 32127
Contact: Nicole Davis    386-767-8800 ext 6676    ndavis@amrcus.com   
Principal Investigator: Ammar Hemaiden, MD         
United States, Louisiana
Delta Research Partners Recruiting
Monroe, Louisiana, United States, 71201
Contact: Melissa McCullars    318-807-0819    mmccullars@gastromds.com   
Principal Investigator: Bal Raj Bhandari, MD         
United States, Maryland
Capital Digestive Care, LLC - Metropolitan Gastroenterology Group (MGG) Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Kathy Tracey    301-652-5520    kathy.tracey@capitaldigestivecare.com   
Principal Investigator: Robert Hardi, MD         
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02115
Contact: Haley Etskovitz    617-667-3197    hetskovi@bidmc.harvard.edu   
Principal Investigator: Alan Moss, MD         
Community Clinical Research Network Recruiting
Marlborough, Massachusetts, United States, 01752
Contact: Kyle Magner    508-320-9248    kmagner@comcast.net   
Principal Investigator: John Curran, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Denise Dahle    507-266-4728    denise.dahle2@mayo.edu   
Principal Investigator: Edward Loftus, MD         
United States, New York
Long Island Clinical Research Associates Recruiting
Great Neck, New York, United States, 11021
Contact: Heather Dufficy    516-466-1051    heather.dufficy@nyumc.org   
Principal Investigator: Robert Tepper, MD         
Concorde Medical Group Recruiting
New York, New York, United States, 10016
Contact: Danny Cadet    212-899-5544 ext 154    dcadet@concordemed.com   
Principal Investigator: Caterina Oneto, MD         
United States, North Carolina
UNC School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Mikki Sandridge    919-966-6806    mikki.sandridge@med.unc.edu   
Principal Investigator: Hans Herfarth, MD         
UNC School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Celeste Cantrell    919-636-0484    celeste.cantrell@med.unc.edu   
Principal Investigator: Hans Herfarth, MD         
Wake Research Associates Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Marsha Peery    919-781-2514    mpeery@wakeresearch.com   
Principal Investigator: Charles Barish, MD         
PMG Research of Salisbury Recruiting
Salisbury, North Carolina, United States, 28144
Contact: Kim Potts    704-647-9913    kpotts@pmg-research.com   
Principal Investigator: Kiran Jagarlamudi, MD         
PMG Research of Winston-Salem Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Gina Barker    336-768-8062    gina.barker@pmg-research.com   
Principal Investigator: Robert Holmes, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Erin Landry    615-322-4573    erin.vozar@vanderbilt.edu   
Principal Investigator: Dawn Beaulieu, MD         
Sponsors and Collaborators
Seres Therapeutics, Inc.
  More Information

Responsible Party: Seres Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02618187     History of Changes
Other Study ID Numbers: SERES-101
Study First Received: November 20, 2015
Last Updated: September 2, 2016

Additional relevant MeSH terms:
Colitis
Ulcer
Colitis, Ulcerative
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Vancomycin
Anti-Bacterial Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on March 24, 2017