CLF065 for Chronic Pouchitis
ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCalibr, a division of Scripps Research
About this trial
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
Qualifiers
Adult subjects aged 18-80 years, inclusive.
In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
Disqualifiers
Inability to give informed consent.
The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)
No prior exposure to CLF065
The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Randomization Visit
Trial design
Treatments tested in this trial
- CLF065
- Placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov