Ongoing Clinical Trials for Cholestatic Pruritus
There are currently 2 ongoing clinical trials investigating new treatments for cholestatic pruritus, a condition characterized by severe itching caused by liver problems. These trials are testing medications that work by blocking bile acid transport to reduce itching symptoms. The studies are being conducted across multiple European countries including Belgium, Bulgaria, Czechia, France, Germany, Greece, Italy, Poland, and Spain.
Clinical trial locations
- Belgium
- Bulgaria
- Czechia
- France
- Germany
- Greece
- Italy
- Poland
- Spain
Study on Long-term Safety of Linerixibat for Treating Itchy Skin in Patients with Primary Biliary Cholangitis
This clinical trial is investigating the long-term safety of linerixibat, a medication taken as oral tablets, for treating severe itching in patients with Primary Biliary Cholangitis. The study aims to monitor participants over an extended period to understand how well the medication is tolerated and what side effects may occur.
Who can participate:
- Adults between 18 and 80 years old
- Patients with a diagnosis of Primary Biliary Cholangitis and a history of itching related to this condition
- Those who have completed the main treatment period in a previous linerixibat study
- Female participants must not be pregnant or breastfeeding, and must use acceptable birth control methods during the study and for at least 4 weeks after the last dose
- Participants must be able to provide informed consent and agree to follow study requirements
Who cannot participate:
- Patients with cholestasis (a condition where bile flow from the liver is reduced or blocked)
- Patients outside the age range of 18 to 65 years in certain trial phases
- People who are part of vulnerable populations that might be at higher risk
What the study involves: Participants will take linerixibat tablets orally and attend regular check-ups at weekly, monthly, and multi-monthly intervals throughout the study period, which can last up to 48 months. The study will monitor any side effects, changes in health status, and impacts on quality of life including sleep and fatigue. A follow-up phone call will be conducted 7 to 14 days after the final dose.
The investigational drug: Linerixibat works by blocking a protein in the intestines that helps transport bile acids. By reducing the amount of bile acids in the body, it may help relieve the severe itching associated with liver disease. It is classified as an ileal bile acid transporter inhibitor.
Study on Maralixibat Chloride for Treating Itchy Skin in Patients with Cholestatic Pruritus
This Phase 3 clinical trial is evaluating the effectiveness of maralixibat chloride compared to a placebo in reducing the severity of itching in patients experiencing cholestatic pruritus. The medication is taken as an oral solution and works by blocking bile acid transport to reduce itching symptoms.
Who can participate:
- Patients at least 6 months old at the time of the first visit
- Those with a diagnosis of cholestatic liver disease with persistent itching for more than 90 days
- Participants must complete at least 10 valid daily entries about their itching during the 2 weeks before the first visit using a tool called ItchRO
- If taking medications for itching or liver disease, patients must have been on a stable dose for at least 30 days before the first visit
- Female participants who can become pregnant must use acceptable birth control methods and have a negative pregnancy test
- Participants must have access to email or telephone and a smartphone or tablet for completing questionnaires
- Those 18 years or younger must have access to a consistent caregiver during the study
Who cannot participate:
- Patients not experiencing cholestatic pruritus
- Those with other medical conditions that might interfere with the study
- Patients taking medications that might affect study results
- Pregnant or breastfeeding individuals
- Those who have participated in another clinical trial recently
- Patients with a history of drug or alcohol abuse
- Those with a known allergy to the study medication
What the study involves: This 40-week study randomly assigns participants to receive either maralixibat chloride or a placebo as an oral solution. Neither participants nor researchers will know who receives which treatment. Throughout the study, participants will record their itch severity using the ItchRO tool and attend regular study visits to monitor their condition and any changes in symptoms. The study aims to determine if there is significant improvement in itching symptoms for those taking the medication compared to those taking placebo.
The investigational drug: Maralixibat chloride is an ileal bile acid transporter inhibitor administered as a liquid solution. It works by blocking specific proteins involved in bile acid transport, which helps reduce the accumulation of bile acids that cause itching. This medication is being studied for its potential to improve comfort and quality of life for people with severe itching due to liver conditions.
Summary
Both ongoing clinical trials are focused on treating the severe itching associated with cholestatic liver conditions by targeting bile acid transport mechanisms. The studies test two different medications in the same drug class: linerixibat and maralixibat chloride, both of which work as ileal bile acid transporter inhibitors.
The linerixibat study is a long-term safety evaluation specifically for patients with Primary Biliary Cholangitis who have previously participated in linerixibat trials, with monitoring periods extending up to 48 months. In contrast, the maralixibat chloride study is a 40-week Phase 3 trial comparing the medication to placebo and is open to a broader age range starting from 6 months old.
Geographically, the trials have considerable overlap in Europe, with both studies being conducted in France, Italy, Poland, and Spain. The linerixibat study has a wider geographical reach, also including Belgium, Bulgaria, Czechia, Germany, and Greece. This concentration of trials in European countries reflects coordinated efforts to address this challenging condition across the continent.
