A Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects With Mild-to-Moderate Ulcerative Colitis
Completed · Phase 1 · Has a placebo group
Conditions studied: Ulcerative Colitis
In brief
A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287 in Subjects with Mild-to-Moderate Ulcerative Colitis.
Key facts
- Study ID
- NCT02618187
- Run by
- Seres Therapeutics, Inc.
- People needed
- 58
- Starts
- 2016-01-13
- Expected to finish
- 2018-01-26
- Last updated by the study team
- 2019-06-20
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
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
- Received an investigational antibody or vaccine within 3 months before study entry
- Previously enrolled in a SER-109/SER-287 study
- Received an FMT within the last 6 months
- 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
- Unable to stop steroid enemas or suppositories or mesalamine enemas or suppositories before screening visit
- Unable to stop opiate treatment unless on a stable dose and no increase in dose planned for the duration of the study
- Unable to stop probiotics before screening visit
- Concurrent intensive induction chemotherapy, radiotherapy, or biologic treatment for active malignancy (subjects on maintenance chemotherapy may only be enrolled after consultation with medical monitor)
- Known allergy or intolerance to oral vancomycin
Where it is running
- Community Clinical Research Network — Marlborough, Massachusetts, United States
Full record on ClinicalTrials.gov
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