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Volixibat

Clinical trials are studying Volixibat in people with itching caused by primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC). These studies aim to see whether Volixibat is effective and safe compared with placebo. Both trials are in phase 2 and measure itch changes using the Adult ItchRO tool.

Table of Contents

Trial overview

Two interventional studies are investigating Volixibat for cholestatic pruritus, which means itching linked to problems with bile flow in liver disease.[1][2] One study is in patients with primary biliary cholangitis (PBC), and the other is in patients with primary sclerosing cholangitis (PSC).[1][2] Both studies are authorised and are in phase 2, which is a study stage used to learn more about whether a treatment may work and to keep checking safety.[1][2]

Phase 2 study in primary biliary cholangitis

The first study, NCT05050136, is a phase 2 interventional trial in people with itching caused by PBC.[1] It plans to include 278 participants.[1] The study title says it is evaluating the efficacy and safety of Volixibat in patients with itching caused by primary biliary cholangitis.[1]

This study compares Volixibat with a placebo, which is a look-alike capsule with no active study drug.[1] The brief summary says the main aim is to evaluate whether Volixibat helps with pruritus in participants with PBC.[1]

Phase 2 study in primary sclerosing cholangitis

The second study, NCT04663308, is also a phase 2 interventional trial and is called VISTAS.[2] It is studying Volixibat in participants with pruritus associated with PSC.[2] This trial plans to enroll 387 participants.[2]

Like the PBC study, this trial compares Volixibat with placebo.[2] The brief summary says the study is designed to evaluate the efficacy of Volixibat versus placebo for the treatment of pruritus in participants with PSC.[2]

What the trials measure

Both studies use the Adult ItchRO tool to measure itch changes over time.[1][2] In the PBC study, the main outcome is the mean change in Adult ItchRO score from baseline to the end of the double-blind treatment period, using weekly average daily itch scores.[1] In the PSC study, the main outcome is the mean change in Adult ItchRO from baseline to the average of the weekly averaged worst daily itch scores.[2]

Baseline means the starting measurement taken before treatment begins.[1][2] A double-blind period means the treatment assignment is kept hidden during that part of the trial, which helps make the comparison fairer.[1]

How the studies are designed

Both studies are interventional, which means researchers assign the study treatment and then observe the results.[1][2] Each study includes a Volixibat group and a placebo group so the researchers can compare itch outcomes between the two groups.[1][2] The trial records do not provide detailed participant rules in the source data, but they clearly focus on adults with itching linked to PBC or PSC.[1][2]

Key patient terms

Pruritus is the medical word for itching, and in these trials it is the symptom being measured.[1][2] PBC and PSC are long-term liver diseases that can be linked to this itching.[1][2] The term enrollment means the planned number of people the study wants to include, which is 278 in one trial and 387 in the other.[1][2]

Trial IDPhaseCondition studiedStatusEnrollment
NCT05050136Phase 2Cholestatic pruritus in patients with primary biliary cholangitis (PBC)Authorised278
NCT04663308Phase 2Pruritus associated with primary sclerosing cholangitis (PSC)Authorised387

FAQ

  • What conditions are being studied in Volixibat trials? The trials are studying itching, also called <b>pruritus</b>, in people with PBC and PSC. These are liver diseases that can cause ongoing itching.
  • What is the main goal of these trials? The main goal is to see whether Volixibat improves itching better than placebo. The studies also look at safety during treatment.
  • What phase are the Volixibat trials? Both available trials are <b>phase 2</b> studies. This means they are testing whether the treatment works and continuing to watch safety.
  • How many people are included in these studies? One trial plans to include 278 participants, and the other plans to include 387 participants. Both are interventional studies, which means researchers assign the study treatment.
  • How is itching measured in these trials? The trials use the <b>Adult ItchRO</b> tool, which tracks itch scores over time. Researchers compare the scores at the start of the study with later scores during treatment.

Ongoing Clinical Trials on Volixibat

  • Study on Volixibat for Treating Itching in Patients with Primary Biliary Cholangitis

    Recruiting

    2 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

  • Study on Volixibat for Treating Itching in Patients with Primary Sclerosing Cholangitis

    Not recruiting

    2 1
    Investigated drugs:
    Belgium France Germany Italy The Netherlands Spain

Glossary

  • Pruritus: A medical word for itching. In these trials, it means ongoing itching caused by liver disease.
  • Primary biliary cholangitis (PBC): A long-term liver disease that can cause itching and other symptoms.
  • Primary sclerosing cholangitis (PSC): A long-term disease of the bile ducts that can also cause itching.
  • Placebo: A look-alike treatment with no active study drug. It helps researchers compare results fairly.
  • Phase 2: A study stage that checks whether a treatment may work and continues to monitor safety.
  • Interventional study: A trial where researchers give a study treatment and follow what happens.
  • Enrollment: The planned number of participants a study aims to include.
  • Adult ItchRO: A patient-reported tool used to measure itch severity over time.
  • Double-blind: A study design where participants and researchers may not know who gets the study drug or placebo during the blinded part.
  • Baseline: The starting point measured before treatment begins.

References