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Farnesoid X receptor agonist

Obeticholic Acid for Barrett's Esophagus

Phase 2

Recruiting

Led By Prashanthi Thota

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable

Eastern Cooperative Oncology Group (ECOG) performance status =< 1 (Karnofsky >= 70%)

Must not have

Pregnant women are excluded from this study because the limited available human data on the use of OCA during pregnancy are not sufficient to inform a drug-associated risk. There is no information on the presence of OCA in human milk, the effects on the breastfed infant or the effects on milk production. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with OCA, breastfeeding should be discontinued if the mother is treated with OCA

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Summary

This trial studies how to reduce cancer risk in people with Barrett's esophagus using obeticholic acid to reduce bile acid levels.

Who is the study for?

This trial is for adults over 18 with Barrett's Esophagus (BE) who have been on proton pump inhibitors for at least a month. They should not have high-grade dysplasia or cancer, no history of ablative therapy in the BE segment, and must be generally healthy without chronic liver disease or uncontrolled illnesses. Participants need to use contraception and cannot be pregnant or breastfeeding.

What is being tested?

The trial is testing obeticholic acid (OCA), which may reduce damage from bile acids in the esophagus by activating FXR to lower bile acid levels and inflammation. It includes questionnaires, biospecimen collection, biopsies, ultrasonography, endoscopy procedures, OCA administration versus placebo.

What are the potential side effects?

Potential side effects of obeticholic acid include itching (pruritus), fatigue, digestive issues like abdominal pain and constipation, headache, dizziness, skin reactions such as rash or eczema. There might also be an increased risk of liver-related adverse events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am mostly active and can care for myself.

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At least one of my biopsy samples shows significant changes typical of Barrett's esophagus.

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I have been taking medication for acid reflux or stomach ulcers for at least a month.

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I have Barrett's esophagus with no, low, or uncertain dysplasia, confirmed by biopsy and it affects at least 2 cm of my esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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My heart disease is not under control.

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I have a skin condition that causes severe itching.

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I have previously used OCA.

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I have never had treatments like radiofrequency ablation or cryotherapy on my BE segment.

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I have had high-grade dysplasia or cancer found in a previous endoscopy.

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I have a chronic liver condition such as cirrhosis or NASH.

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My cholesterol levels are not under control.

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I am currently taking warfarin.

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I am not taking medications like clozapine, theophylline, or tizanidine.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean change Leucine-rich repeat-containing G-protein coupled receptor 5 (LGR) 5+ cells

Other study objectives

CDX2/SOX2 and p53 staining

Changes in markers

FGF-19 analysis

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (OCA)Experimental Treatment6 Interventions

Patients receive OCA PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound during screening, EGD with biopsies, brushings and gastric aspirate at end of treatment visit and blood sample collection throughout the study.

Group II: Arm II (placebo)Placebo Group6 Interventions

Patients receive placebo PO QD for 6 months in the absence of disease progression or unacceptable toxicity. Patients undergo liver ultrasound during screening, EGD with biopsies, brushings and gastric aspirate at end of treatment visit and blood sample collection throughout the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Esophagogastroduodenoscopy

2017

Completed Phase 3

~1450

Biospecimen Collection

2004

Completed Phase 3

~2030