Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
Phase 3 · Testing norucholic acid · Sites not listed yet · Dr. Falk Pharma GmbH
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing norucholic acid (a drug) as a possible treatment. Condition(s) listed: Primary Sclerosing Cholangitis.
It is open-label: participants know what they are receiving.
Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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…
There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 120 participants are expected to take part.
- The study has 1 group.
- Start date: 2025-03 (planned).
- Main results expected around 2027-09 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Groups in this study
- norucholic acid 1500 mg/day (listed as: experimental group)
Main thing being measured
- 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)
In the researchers’ words
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Words you might see
- Cirrhosis: advanced scarring of the liver.
- Open-label: everyone, including participants, knows which treatment is being given.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Primary Sclerosing Cholangitis |
| Lead sponsor | Dr. Falk Pharma GmbH |
| Enrollment | 120 (estimated) |
| Start date | 2025-03 |
| Primary completion (est.) | 2027-09 |
| First posted | 2025-03-20 |
| Last updated | 2025-03-20 |
| Official title | An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets |
| ClinicalTrials.gov ID | NCT06886360 |
Interventions
- norucholic acid (Drug)
500 mg norucholic acid film-coated tablets; 3 tablets/day
Full eligibility criteria (from the record)
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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.