A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis

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NCT05050136 · readout ≤ 253 d

Sponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.

Phase

Phase 2

Status

Recruiting

Study type

Interventional

Design

Randomized · Double · Treatment

Enrollment

260estimated

Sites

130

Countries

Argentina, Belgium, Brazil +12

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis

Date

Filed

Basis

What it is

Start

2021-09-22

actual

When the study began enrolling

Primary completion

Apr 2027

estimated

The date the last participant is measured for the primary outcome — the readout window

Study completion

Jul 2027

estimated

The whole study's end, after follow-up

First posted

2021-09-20

actual

When this record first appeared on the registry

Results posted

—

When the sponsor posted results to the registry

Record updated

2026-05-14

actual

The sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

Primary Biliary Cholangitis
PBC

Interventions

Drug: Volixibat — also filed as SHP626
Drug: Placebo

Primary outcome

what the primary-completion date above is the date OF

Mean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire

measured Baseline to week 28

Publications

PMID 40439725 — linked by the registry

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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