A Randomized Double-Blind Placebo-Controlled Study to Evaluate Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis (VISTAS)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-505764-11-00

Acronym

VLX-301

Enrollment

105

Registered

2023-07-18

Start date

2022-06-10

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pruritus associated with Primary Sclerosing Cholangitis (PSC)

Brief summary

Mean change in the Adult ItchRO comparing baseline with the average of the weekly averaged worst daily itch scores.

Interventions

DRUGvolixibat

DRUGPlacebo

DRUGcapsule

DRUGhard

DRUGoral use

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Mean change in the Adult ItchRO comparing baseline with the average of the weekly averaged worst daily itch scores.	—

Countries

Belgium, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026