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

Dr. Falk Pharma

Status and phase: Not yet enrolling; Phase 3

Conditions: Primary Sclerosing Cholangitis

Treatments: Drug: norucholic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT06886360

2024-514292-18-00 (EU Trial (CTIS) Number)

NUT-022/PSC

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 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.)

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

norucholic acid 1500 mg/day

Experimental group

Description:

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

Treatment:

Drug: norucholic acid