Actively Recruiting
CLF065 for Chronic Pouchitis
Led by Calibr, a division of Scripps Research · Updated on 2026-03-05
20
Participants Needed
1
Research Sites
64 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
CLF065 for Chronic Pouchitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 18-80 years, inclusive
- Able to understand and follow study requirements
- Signed informed consent and privacy authorization
- Diagnosis of recurrent pouchitis with mPDAI score ≥ 5 and endoscopic subscore ≥ 2, plus either ≥ 3 episodes treated with antibiotics in past year or continuous antibiotic therapy for ≥ 4 weeks prior to baseline
- History of proctocolectomy and IPAA for ulcerative colitis at least one year before screening
- Agree to stop antibiotic therapy
- Agree to taper corticosteroid or budesonide starting by Week 4
- Nonsterilized males sexually active with female partners of childbearing potential agree to use barrier contraception during study
- Women of childbearing potential must have negative pregnancy tests at screening and baseline and use effective contraception through 30 days after last dose
- Judged to be in good health based on medical history, labs, and exam
You will not qualify if you...
- Unable to give informed consent
- Received investigational product, approved biologic, or biosimilar agent within 60 days or 5 half-lives before randomization
- Prior exposure to CLF065
- Received 6-MP, Azathioprine, or methotrexate within 4 weeks of screening
- Crohn's disease proximal to pouch inlet confirmed on imaging or endoscopy
- Irritable pouch syndrome
- Predominant or isolated cuffitis
- Mechanical pouch complications
- Presence of diverting stoma
- Planned surgical intervention of the pouch
- History of malignancy within 2 years except localized skin cancers, carcinoma in situ of cervix, or localized prostate cancer
- Pregnant or breastfeeding
- Lack of effective contraception in women of childbearing potential
- Ongoing treatment with NSAIDs
- Anastomotic or anal canal stricture preventing endoscopy
- Evidence of pelvic sepsis or penetrating fistulizing disease
- Known primary sclerosing cholangitis
- Fecal transplantation within 12 weeks prior to enrollment
- Significant medical conditions or risks interfering with participation
- Laboratory abnormalities: hemoglobin <8 g/dL, WBC <3 x 10^9/L, platelet count <100 or >1200 x 10^9/L, serum creatinine >2 x ULN, ALT or AST >2 x ULN, alkaline phosphatase >2 x ULN
AI-Screening
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Trial Site Locations
Total: 1 location
1
Phillip Fleshner, M.D. Inc
Los Angeles, California, United States, 90048
Actively Recruiting
Research Team
A
Amy Camblos
CONTACT
A
Amy Lightner, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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