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

Last updated: March 19, 2025
Sponsor: Dr. Falk Pharma GmbH
Overall Status: Active - Not Recruiting

Phase

3

Condition

Gall Bladder Disorders

Liver Disease

Liver Disorders

Treatment

norucholic acid

Clinical Study ID

NCT06886360
NUT-022/PSC
2024-514292-18-00
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion criteria:

  1. Signed informed consent.

  2. Males or females ≥ 18 years.

  3. 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 prematurelyterminated the DBE phase before this trial has been started, or has prematurelyterminated the DBE phase after this trial has been started, under the condition thatthe premature termination was due to lack of efficacy*. (*Lack of efficacy asdefined in the NUC-5/PSC trial.)

Exclusion

Exclusion Criteria:

  1. History or presence of chronic alcoholic consumption (daily consumption > 30 g inmen, > 20 g in women).

  2. Patients who discontinued study participation in NUC-5/PSC due to an AE possiblycaused by the study drug.

  3. Liver Cirrhosis or any cirrhosis-related symptoms which in the opinion of theinvestigator may affect the patient's safety.

  4. History of liver transplantation or patient listed for transplantation.

Study Design

Total Participants: 120
Treatment Group(s): 1
Primary Treatment: norucholic acid
Phase: 3
Study Start date:
March 01, 2025
Estimated Completion Date:
September 30, 2027