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

NCT06886360 | Not Yet Recruiting Phase 3

• 2 other identifiers: NUT-022/PSC2024-514292-18-00
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Primary Sclerosing Cholangitis

Outcome Measures

Primary Outcomes (7)

• 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

• 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

Study Arms (1)

norucholic acid 1500 mg/day

EXPERIMENTAL

3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg

Drug: norucholic acid

Interventions

norucholic acid DRUG

500 mg norucholic acid film-coated tablets; 3 tablets/day

norucholic acid 1500 mg/day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent.
• Males or females ≥ 18 years.
• Patient has previously been diagnosed with PSC, has participated in the previous NUC 5/PSC trial and has completed the DBE phase with Visit 22, or has prematurely terminated the DBE phase before this trial has been started, or has prematurely terminated the DBE phase after this trial has been started, under the condition that the premature termination was due to lack of efficacy\*. (\*Lack of efficacy as defined in the NUC-5/PSC trial.)

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Falk Pharma GmbH: lead

MeSH Terms

Conditions

Cholangitis, Sclerosing

Condition Hierarchy (Ancestors)

Cholangitis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Michael Trauner, MD

  Medical University of Vienna, dept. of Internal Medicine III

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Stiess, PhD

CONTACT

+497611514 Ext. 0; zentrale@drfalkpharma.de

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2025
• First Posted: March 20, 2025
• Study Start: March 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share