CLF065 for Chronic Pouchitis
ConditionPouchitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCalibr, a division of Scripps Research
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
The patient has a history of proctocolectomy and construction of an IPAA for ulcerative colitis at least one year before the Screening Visit.
Disqualifiers
Inability to give informed consent.
The patient has received any investigational product or approved biologic or biosimilar agent within 60 days or 5 half-lives of randomization (whichever is longer)
No prior exposure to CLF065
The patient has received 6-MP, Azathioprine or methotrexate within 4 weeks of the Randomization Visit
Trial design
Design model
Parallel
Treatments tested in this trial
CLF065
Drugwill receive investigational product every week for 13 weeks as a sub-cutaneous injection
Placebo
DrugCLF065 matching placebo
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: CLF065Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline, Week 14, Week 24Secondary outcomes
1
Change from baseline in Simple Endoscopic Score for Crohn's disease (SES-CD)
The Simple Endoscopic Score for Crohn's Disease (SES-CD) is a validated tool used to evaluate endoscopic disease activity in Crohn's disease. It assesses four key parameters: (1) the size of ulcers, (2) the ulcerated surface, (3) the affected surface, and (4) the presence of stenosis across five bowel segments (ileum, right colon, transverse colon, left colon, and rectum). Each parameter is scored from 0 to 3 for a total score range of 0-56. Higher scores indicate more severe endoscopic disease activity.
Time frame
Baseline and Week 14 and Week 242
Robarts Histopathology Index (RHI)
For histologic assessment, biopsies will be collected and sent for independent central review. Histologic inflammation will be assessed using the Robarts Histopathology Index (RHI) for chronic pouchitis. Each component is scored 0 - 3 and the total possible score is 33, with higher scores reflecting greater histologic disease activity.
Time frame
Baseline and Week 14 and Week 24Sponsors and contacts
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Source ClinicalTrials.gov