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CLF065 for Chronic Pouchitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

CLF065 for Chronic Pouchitis

A Randomized, Placebo-Controlled Phase 2 Study to Evaluate the Safety and Efficacy of CLF065 in the Treatment of Chronic Pouchitis

NCT07226050•Calibr, a division of Scripps Research

View on ClinicalTrials.gov

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.

Detailed 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

18 - 80 years

Sex

ALL

Healthy Volunteers

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.
+2 more criteria

Exclusion Criteria

•1. Inability to give informed consent.
•2. 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)
•3. No prior exposure to CLF065
•4. Chronic pouchitis specific:
•1. The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Screening Visit
•2. Crohn's disease with disease proximal to the pouch inlet confirmed on prior imaging or endoscopy
•3. Irritable pouch syndrome
•4. Predominate or isolated cuffitis
•5. Mechanical complications of the pouch
•6. Diverting stoma
+17 more criteria

Locations (1)

Phillip Fleshner, M.D. Inc

Los Angeles, California, United States

Key Dates

Start Date

March 5, 2026

Primary Completion Date

March 1, 2027

Completion Date

June 1, 2027

Last Updated

March 5, 2026

Enrollment

ESTIMATED participants

Conditions

Pouchitis

Interventions

CLF065

DRUG

Placebo

DRUG

Contacts

Amy Camblos

CONTACT

540 421 7096 clinicaltrials@scripps.edu

Amy Lightner, M.D

CONTACT

clinicaltrials@scripps.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 5, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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CLF065 for Chronic Pouchitis

Inclusion Criteria

Exclusion Criteria

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