Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)

Phase 3

Not yet recruiting

• Conditions: Primary Sclerosing Cholangitis
• Interventions: Drug: norucholic acid

• Registration Number: NCT06886360
• Lead Sponsor: Dr. Falk Pharma GmbH

Brief Summary

Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study Start: 2025-03
• Study First Submitted: 2025-03-14
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20
• Primary Completion: 2027-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

1. History or presence of chronic alcoholic consumption (daily consumption > 30 g in men, > 20 g in women).
2. Patients who discontinued study participation in NUC-5/PSC due to an AE possibly caused by the study drug.
3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of the investigator may affect the patient's safety.
4. History of liver transplantation or patient listed for transplantation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
norucholic acid 1500 mg/day	norucholic acid	3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment emergent adverse events leading to study withdrawal	72 weeks from enrollment to end of treatment
Occurrence of adverse events leading to death	72 weeks from enrollment to end of treatment
Occurrence of treatment emergent adverse events	72 weeks from enrollment to end of treatment
Occurrence of serious treatment emergent adverse events	72 weeks from enrollment to end of treatment
Occurrence of severe treatment emergent adverse events	72 weeks from enrollment to end of treatment
Occurrence of adverse drug reactions	72 weeks from enrollment to end of treatment
Occurrence of unexpected treatment emergent adverse events	72 weeks from enrollment to end of treatment