Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-510200-42-00

Acronym

NUC-5/PSC

Enrollment

195

Registered

2024-10-14

Start date

2017-12-06

Completion date

Unknown

Last updated

2025-07-15

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

Conditions

primary sclerosing cholangitis (PSC)

Brief summary

Partial normalization of s-ALP and no worsening of disease stage as determined by the Ludwig stage.

Detailed description

Partial normalization of s-ALP and no worsening of disease stage as determined by the modified Nakanuma score at the week 96 visit compared to baseline as key secondary endpont. Liver stiffness, fibrosis stage, liver histology, dominant strictures, quality of life as other secondary endpoints.

Interventions

DRUGNUC01

DRUGPlacebo to NUC01

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Partial normalization of s-ALP and no worsening of disease stage as determined by the Ludwig stage.	—

Secondary

Measure	Time frame
Partial normalization of s-ALP and no worsening of disease stage as determined by the modified Nakanuma score at the week 96 visit compared to baseline as key secondary endpont. Liver stiffness, fibrosis stage, liver histology, dominant strictures, quality of life as other secondary endpoints.	—

Countries

Austria, Denmark, Finland, France, Germany, Hungary, Netherlands, Norway, Poland

Outcome results

None listed

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