Primary Sclerosing CholangitisPhase 3NCT06886360
Study with Norucholic Acid Tablets in Patients with Primary Sclerosing Cholangitis (PSC)
A Phase 3 study testing norucholic acid in people with Primary Sclerosing Cholangitis, run by Dr. Falk Pharma GmbH.
Trial summary
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Sclerosing Cholangitis
- What is being tested?
- norucholic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
- Conditions
- Primary Sclerosing Cholangitis
- Being tested
- norucholic acid
- Medical subject headings
- Cholangitis, Sclerosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norucholic acidDrug
500 mg norucholic acid film-coated tablets; 3 tablets/day
| Study group | Role | What they receive |
|---|---|---|
| norucholic acid 1500 mg/day | Experimental | 3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg Receives: Drug: norucholic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of treatment emergent adverse events
Measured: 72 weeks from enrollment to end of treatment
Occurrence of serious treatment emergent adverse events
Measured: 72 weeks from enrollment to end of treatment
Occurrence of severe treatment emergent adverse events
Measured: 72 weeks from enrollment to end of treatment
Occurrence of adverse drug reactions
Measured: 72 weeks from enrollment to end of treatment
Occurrence of unexpected treatment emergent adverse events
Measured: 72 weeks from enrollment to end of treatment
Occurrence of treatment emergent adverse events leading to study withdrawal
Measured: 72 weeks from enrollment to end of treatment
Occurrence of adverse events leading to death
Measured: 72 weeks from enrollment to end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sclerosing CholangitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Trauner, MD, Principal investigator, Medical University of Vienna, dept. of Internal Medicine III
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886360
- Sponsor's protocol ID
- NUT-022/PSC
- Other IDs
- 2024-514292-18-00
- Status last verified
- Mar 2025
- First submitted
- 14 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is not decided which data will be made available. A time frame cannot be indicated yet.
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study of Patients with Primary Sclerosing Cholangitis (PSC) Treated with Norucholic Acid Tablets
- ClinicalTrials.gov ID
- NCT06886360
- Acronym / sponsor ID
- NUT-022/PSC
- Conditions
- Primary Sclerosing Cholangitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Mar 2025 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label, multi-center, phase III trial. Oral treatment with 1500 mg norucholic acid in Primary Sclerosing cholangitis
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| norucholic acid 1500 mg/day | Experimental | Drug: norucholic acid3 film-coated tablets once daily for 72 weeks containing in total norUrsodeoxycholic acid 1500 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| norucholic acid500 mg norucholic acid film-coated tablets; 3 tablets/day | Drug | norucholic acid 1500 mg/day |
Primary outcome
Occurrence of treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of serious treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of severe treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of adverse drug reactions
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of unexpected treatment emergent adverse events
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of treatment emergent adverse events leading to study withdrawal
Time frame: 72 weeks from enrollment to end of treatment
Occurrence of adverse events leading to death
Time frame: 72 weeks from enrollment to end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: No. It is not decided which data will be made available. A time frame cannot be indicated yet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Trauner, MD principal investigator
Medical University of Vienna, dept. of Internal Medicine III
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing norucholic acid in people with Primary Sclerosing Cholangitis, run by Dr. Falk Pharma GmbH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Stiess, PhD (+497611514 Ext. 0, zentrale@drfalkpharma.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of treatment emergent adverse events (time frame: 72 weeks from enrollment to end of treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.