An Open-label study of patients with primary sclerosing cholangitis (PSC) treated with norucholic acid tablets

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-514292-18-00

Acronym

NUT-022/PSC

Enrollment

Registered

2025-03-10

Start date

2025-03-24

Completion date

Unknown

Last updated

2025-08-25

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

Occurrence of Treatment emergent adverse events (TEAEs), Occurrence of Serious TEAEs, Occurrence of Severe TEAEs, Occurrence of Adverse Drug reactions (ADRs), Occurrence of Unexpected TEAEs

Detailed description

(Safety) Changes from baseline in vital signs (blood pressure, heart rate) and body weight, (Safety) Changes from baseline in hematology, serum chemistry (other than efficacy variables) and urinalysis, (Efficacy) Course of liver stiffness, (Efficacy) s-ALP in categories from baseline to EoT

Interventions

DRUGNUT01

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Occurrence of Treatment emergent adverse events (TEAEs), Occurrence of Serious TEAEs, Occurrence of Severe TEAEs, Occurrence of Adverse Drug reactions (ADRs), Occurrence of Unexpected TEAEs	—

Secondary

Measure	Time frame
(Safety) Changes from baseline in vital signs (blood pressure, heart rate) and body weight, (Safety) Changes from baseline in hematology, serum chemistry (other than efficacy variables) and urinalysis, (Efficacy) Course of liver stiffness, (Efficacy) s-ALP in categories from baseline to EoT	—

Countries

Austria, Belgium, Denmark, France, Germany, Hungary, Netherlands, Norway, Poland, Sweden

Outcome results

None listed

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