Learn how you can get involved to support a phase 3 study for adult patients with moderate-to-severe cholestatic pruritus in primary biliary cholangitis (PBC).
About the Research Study
GlaxoSmithKline is currently conducting a Phase 3, randomized, double-blind, placebo-controlled study called GLISTEN. The study is researching the efficacy and safety of an investigational oral medication, linerixibat, for the treatment of cholestatic pruritus in PBC. The GLISTEN Study is currently enrolling patients in up to 20 countries worldwide, with the option to participate in person or remotely in the United States.
Patients 18-80 years of age who have been diagnosed with PBC and have moderate-to-severe cholestatic pruritus may be eligible to participate. Most current medications for PBC (except obeticholic acid) and for cholestatic pruritus can be continued during study duration as long as doses are kept stable.
About the Investigational Medication Linerixibat
It is hypothesized that a build-up of bile acids in the bloodstream is involved in the pathophysiology of pruritus. 1 A new class of investigational medicines called IBAT (ileal bile acid transporter) inhibitors may help to increase bile acid elimination via increased intestinal excretion, thereby relieving itching.
Linerixibat is an orally administered IBAT inhibitor that has shown efficacy and safety in Phase 2a and 2b clinical trials. The GLIMMER trial2 assessed linerixibat over a 12-week period in 147 people with cholestatic pruritus related to PBC across 10 countries. With some doses tested, the intensity of the pruritus significantly diminished. The most common side effect was diarrhea but this was generally mild-to-moderate.
How You Can Get Involved
As a health care provider (HCP) who manages PBC patients with moderate-to-severe cholestatic pruritus, you are invited to participate in the Effectus Patient Identification and Consultation Program to help identify candidates for the GLISTEN Study. Should you decide to participate, you would identify which of your adult patients meet the provided inclusion/exclusion criteria and discuss the opportunity with them to participate at the nearby study site or remotely. Patients will undergo formal study screening with the Principal Investigator to determine eligibility.
Compensation at fair market value will be available for HCPs who participate and meet program requirements.
References
1. Lindor KD et al. Hepatol. 2019; 69:394-419.
2. GLIMMER trial results: Gastroenterol Hepatol (NY). 2021; 17 (2 Suppl 3): 11-12.
The Effectus Patient Identification and Consultation Program
Effectus Patient Identification and Consultation Program Overview
Support Provided
Effectus will be your trusted partner throughout your participation, helping to facilitate your patients throughout the screening process and thus relieving the burden on your practice. If you wish to participate, you will be asked to review and sign a Services Agreement with Effectus, which outlines your program responsibilities and compensation. Participation is completely voluntary, and you can opt out at any time. Background on the study, program materials, and program logistics will be reviewed in detail during a 1-hour virtual training session, for which you will be compensated.
Why Participate?
The GLISTEN Study provides an opportunity to contribute to the research and advancement of a potential new medication for cholestatic pruritus in PBC.
Sign a services
agreement.
Receive a package of
program materials and
complete a simple, one-hour
virtual training session.
Utilize key screening
criteria to identify
potentially eligible
patients.
If the patient meets the criteria,
conduct a neutral consultation
about the availability of the
nearby study and gauge the
patient’s interest.
If the patient is interested in
participation, our team of dedicated
Patient Facilitators help ensure a
smooth patient transfer from your
office to the study.
The patient is scheduled
and presents at the study
site for the screening
appointment.
The patient’s enrollment
status is determined and is
relayed back to the treating
HCP by Effectus.
For more information on our program, please visit https://www.effectusctr.com/physician-network/.
The Effectus Patient Identification and Consultation Program
Contact Us
Montana Markell, Project Coordinator
Phone: 703-635-8975
Email: mmarkell@effectusctr.com