A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Sclerosing Cholangitis (PSC)
← catalyst calendarSponsored by Mirum Pharmaceuticals, Inc. (industry) · MIRM — their whole pipeline →.
Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
182actual
Sites
103
Countries
Argentina, Australia, Belgium +11
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 | 2020-12-18 | actual | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2027 | estimated | The whole study's end, after follow-up |
| First posted | 2020-12-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-04 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Primary Sclerosing Cholangitis
Interventions
- Drug: Volixibat — also filed as SHP626
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFMean change in the daily itch scores using the Adult Itch Reported Outcome (Adult ItchRO) questionnaire
measured Baseline through to Week 28
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