RecruitingPhase 2

CLF065 for Chronic Pouchitis

United States20 participantsStarted 2026-03-05

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.
✓. 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:
✓. The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
✓. The patient agrees to stop antibiotic therapy.
✓. Patient agrees to taper any corticosteroid or budesonide starting by Week 4 of the study per guidelines below.
✓. 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.

Exclusion criteria

✕. Inability to give informed consent.
✕. The patient has received any investigational product or approved biologic or biosimilar agent within 60 days of 5 half-lives of randomization (whichever is longer)
✕. No prior exposure to CLF065
✕. Chronic pouchitis specific:
✕. The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Screening Visit
✕. Crohn's disease with disease proximal to the pouch inlet confirmed on prior imaging or endoscopy
✕. Irritable pouch syndrome
✕. Predominate or isolated cuffitis

What they're measuring

Change from baseline in Pouchitis Disease Activity Index (PDAI) and Modified PDAI

Timeframe: Baseline, Week 14, Week 24

Trial details

NCT IDNCT07226050

SponsorCalibr, a division of Scripps Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Amy Camblos

540 421 7096 clinicaltrials@scripps.edu

View on ClinicalTrials.gov More Pouchitis trials