Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
A Multiple Dose Study to Evaluate the Safety, Tolerability and Microbiome Dynamics of SER-287
in Subjects with Mild-to-Moderate Ulcerative Colitis.
Phase
Phase 1
Funding Agency/Sponsor
Industry
Disease
Other
Enrollment Eligibility
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
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