A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis
Calibr, a division of Scripps Research
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.
Description
CLF065 is a long acting Glucagon-like peptide-2 (GLP-2). Participants will receive CLF065 or a placebo as a subcutaneous injection (just under the skin) once a week for the first 13 weeks of a 24-week total study period. Some weeks the subcutaneous injection will be given at the study site and some weeks it will be self-administered. Participants will be asked to complete a daily bowel diary card in addition to questionnaires about living with chronic pouchitis.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugCLF065
will receive investigational product every week for 13 weeks as a sub-cutaneous injection
- DrugPlacebo
CLF065 matching placebo
Location
- Phillip Fleshner, M.D. IncLos Angeles, California