CLF065 for Chronic Pouchitis

NCT07226050 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CBR-CLF065-4001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pouchitis

Keywords

chronic pouchitis

Outcome Measures

Primary Outcomes (1)

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

  The PDAI contains three separate 6-point domain scales based on clinical symptoms, endoscopic inflammation, and acute histologic inflammation. On the scale, 0 = normal and 6 = severe inflammation with an overall possible score of 18 points. Higher scores indicate more severe disease. Patients with a total PDAI score \>7 points are classed as having pouchitis. The clinical symptom scale assesses stool frequency, rectal bleeding, fecal urgency, and fever. The endoscopic inflammation scale evaluates edema, granularity, friability, loss of vascular pattern, mucus exudates, and ulceration. The modified PDAI is without the histologic findings.

  Baseline, Week 14, Week 24

Secondary Outcomes (2)

• Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD)

  Baseline and Week 14 and Week 24

• Robarts Histopathology Index (RHI)

  Baseline and Week 14 and Week 24

Study Arms (2)

CLF065

EXPERIMENTAL

CLF065 subcutaneous weekly

Drug: CLF065

Placebo

PLACEBO COMPARATOR

Matching placebo subcutaneous weekly

Drug: Placebo

Interventions

CLF065 DRUG

will receive investigational product every week for 13 weeks as a sub-cutaneous injection

CLF065

Placebo DRUG

CLF065 matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 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
• 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.
• 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.
• If female, the patient must be either postmenopausal, OR permanently surgically sterile or for women of childbearing potential practicing at least one protocol specified method of birth control, that is effective from baseline visit through at least 30 days after the last dose of study drug.
• Patient is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination

You may not qualify if:

• 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
• Mechanical complications of the pouch
• Diverting stoma
• Planned surgical intervention of the pouch
• History of malignancy including melanoma (with the exception of localized skin cancers, carcinoma in situ of the cervix and localized prostate cancer) within 2 years of study enrollment
• Pregnant or breast feeding.
• Lack of effective contraception in women of childbearing potential.
• Ongoing treatment with NSAID (nonsteroidal anti-inflammatory drug).

Sponsors & Collaborators

• Calibr, a division of Scripps Research: lead

Study Sites (1)

Phillip Fleshner, M.D. Inc

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Pouchitis

Condition Hierarchy (Ancestors)

Ileitis; Enteritis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Ileal Diseases

Central Study Contacts

Amy Camblos

CONTACT

540 421 7096; clinicaltrials@scripps.edu

Amy Lightner, M.D

CONTACT

clinicaltrials@scripps.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: March 5, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)