In short
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.
Key points
- Clinical trials of Volixibat are focused on people with itching caused by liver diseases, especially primary biliary cholangitis and primary sclerosing cholangitis. Both studies are phase 2 interventional trials and are listed as authorised. The trials compare Volixibat with placebo to see whether it improves itch symptoms. They use the Adult ItchRO tool to measure changes in itching over time. One study plans to enroll 278 participants, and the other plans to enroll 387 participants. These trials are designed to evaluate both efficacy and safety in the target patient groups.
Trial overview
Two interventional studies are investigating Volixibat for cholestatic pruritus, which means itching linked to problems with bile flow in liver disease. One study is in patients with primary biliary cholangitis (PBC), and the other is in patients with primary sclerosing cholangitis (PSC). 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.
Phase 2 study in primary biliary cholangitis
The first study, NCT05050136, is a phase 2 interventional trial in people with itching caused by PBC. It plans to include 278 participants. The study title says it is evaluating the efficacy and safety of Volixibat in patients with itching caused by primary biliary cholangitis.
This study compares Volixibat with a placebo, which is a look-alike capsule with no active study drug. The brief summary says the main aim is to evaluate whether Volixibat helps with pruritus in participants with PBC.
Phase 2 study in primary sclerosing cholangitis
The second study, NCT04663308, is also a phase 2 interventional trial and is called VISTAS. It is studying Volixibat in participants with pruritus associated with PSC. This trial plans to enroll 387 participants.
Like the PBC study, this trial compares Volixibat with placebo. 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.
What the trials measure
Both studies use the Adult ItchRO tool to measure itch changes over time. 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. 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.
Baseline means the starting measurement taken before treatment begins. A double-blind period means the treatment assignment is kept hidden during that part of the trial, which helps make the comparison fairer.
How the studies are designed
Both studies are interventional, which means researchers assign the study treatment and then observe the results. Each study includes a Volixibat group and a placebo group so the researchers can compare itch outcomes between the two groups. 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.
Key patient terms
Pruritus is the medical word for itching, and in these trials it is the symptom being measured. PBC and PSC are long-term liver diseases that can be linked to this itching. 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.