<?xml version="1.0" encoding="UTF-8"?><protocol_summary><protocol><id>14212</id><no>VLX-601</no><status>Open</status><title>A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Biliary Cholangitis (VANTAGE)</title><objective>The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Biliary Cholangitis (PBC), and to assess the possible impact on the disease progression of PBC.</objective><nct_id>NCT05050136</nct_id><sponsor_type>Industrial</sponsor_type><age_group>Adult</age_group><treatment_type>Treatment</treatment_type><treatment>Drug: Volixibat&#xD;
Drug: Placebo</treatment><phase>II</phase><disease_site>Other</disease_site><lay_description>This study investigates the following conditions or diseases: Primary Biliary Cholangitis&#xD;
PBC</lay_description><PI>Smith, Coleman</PI><institution>MedStar Health Fairfax</institution><management_group>MedStar Medical &amp; Surgical Research Network</management_group></protocol><sipVersion>2026.1.0 Build 16</sipVersion><copyright> &lt;a href="https://advarra.com" target="_blank"&gt;&amp;copy; 2026 Advarra, Inc.&lt;/a&gt; </copyright></protocol_summary>