Trial Parameters
Brief Summary
This clinical trial is to evaluate investigational compound CLF065 as a treatment for adult patients with chronic pouchitis. The goals are to establish the safety, feasibility and efficacy of weekly dosing of long acting CLF065 versus placebo.
Eligibility Criteria
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