NCT07226050

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Calibr, a division of Scripps Research · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pouchitis

Interventions

Type	Name	Description
DRUG	CLF065	will receive investigational product every week for 13 weeks as a sub-cutaneous injection
DRUG	Placebo	CLF065 matching placebo

Timeline

• Start date: 2026-03-05
• Primary completion: 2027-03-01
• Completion: 2027-06-01
• First posted: 2025-11-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study