CLF065 for Chronic Pouchitis

Inclusion Criteria

• •1. Adult subjects aged 18-80 years, inclusive.
• •2. In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
• •3. The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
• •4. Diagnosis of pouchitis that is recurrent, defined by mPDAI score of ≥ 5 assessed as the average from 3 days immediately prior to Baseline endoscopy, and a minimum endoscopic subscore of 2 (outside the staple or suture line) with either:
• •≥ 3 episodes of pouchitis within 1 year of Screening visit, each treated with antibiotic or other prescription therapy for at least 2 weeks OR Requiring maintenance antibiotic therapy taken continuously for ≥ 4 weeks immediately prior to the Baseline endoscopic visit
• •5. The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
• •6. The patient agrees to stop antibiotic therapy.
• •7. Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.
• •8. A male subject who is nonsterilized and sexually activity with a female partner of childbearing potential agrees to use a barrier method of contraception (e.g., condom with spermicide) from signing informed consent throughout the duration of the study.
• •9. Women of childbearing potential must not have a positive pregnancy test at the Screening Visit and must have a negative pregnancy test at the baseline visit prior to study drug dosing. Note: subjects with borderline serum pregnancy test at Screening must have an absence of clinical suspicion of pregnancy or other pathological cause of a borderline result and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result.
• •10. If female, the patient must be either postmenopausal, OR permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, that is effective from baseline visit through at least 30 days after the last dose of study drug.
• •11. Patient is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination