Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against capsules without active substance), phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo (without active substance) in the treatment of PSC (inflammation of the bile ducts with scar formation)

Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-002754-31-DE

Enrollment

160

Registered

2012-05-11

Start date

2012-08-02

Completion date

Unknown

Last updated

2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

primary sclerosing cholangitis MedDRA version: 18.1 Level: LLT Classification code 10036732 Term: Primary sclerosing cholangitis System Organ Class: 100000004871

Interventions

Product Name: norursodeoxycholic acid Pharmaceutical Form: Capsule INN or Proposed INN: norursodeoxycholic acid CAS Number: 99697-24-2 Other descriptive name: NorUDCA Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Signed informed consent, 2. Male or female patients = 18 and =65 years) yes F.1.3.1 Number of subjects for this age range 40

Exclusion criteria

Exclusion criteria: 1. History or presence of other concomitant liver diseases including: • Positive hepatitis B or C serology (Hbs Ag+, anti-HBc+, anti-HCV; Note: Patients who present with anti-HBc+ only, may be included if they are HBV-DNA negative) • Primary Biliary Cirrhosis, (AMA-positive) • Wilson’s Disease • Haemochromatosis • Autoimmune Hepatitis • Chronic alcoholic consumption (daily consumption >30g/d) • Biopsy proven NASH • Cholangiocarcinoma, 2. Treatment with any of the following drugs within the last 3 months prior to baseline: any glucocorticosteroids (including budesonide), azathioprine or other immunosuppressive drugs (e.g. cyclophosphamide, cyclosporine, methotrexate, tacrolimus, 6-mercaptopurine), chlorambucil, pentoxyfylline, penicillamine, pirfenidone, fibrates, biologics (e.g., anti-tumor necrosis factor-alpha therapy), or rifampicin, 5. Child B/C liver cirrhosis, 12. Total bilirubin > 3.0 mg/dl (> 51.3 µmol/L), at screening or baseline, 13. Both, total bilirubin levels > ULN within the last 6 months prior to baseline and a rise of this level by more than 50% within the last 6 months prior to baseline, 14. Albumin 1.15 x ULN) at screening and/or at baseline visit, 18. TSH > ULN at screening, 20. Any active malignant disease, 21. Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC; To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III;Secondary Objective: To study safety and tolerability (adverse events, laboratory parameters) of norUDCA; To assess quality of life;Primary end point(s): The primary endpoint is the change in serum alkaline phosphatase.;Timepoint(s) of evaluation of this end point: At the EOT visit.	—

Measure

Time frame

Main Objective: To evaluate the efficacy of three doses of norUDCA vs. placebo for the treatment of PSC; To identify efficacious norUDCA dose(s) for the treatment of PSC for further evaluation in phase III;Secondary Objective: To study safety and tolerability (adverse events, laboratory parameters) of norUDCA; To assess quality of life;Primary end point(s): The primary endpoint is the change in serum alkaline phosphatase.;Timepoint(s) of evaluation of this end point: At the EOT visit.

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy endpoints are: · s-ALP at each study visit (screening to follow-up) · ?-GT, AST, ALT and serum bilirubin levels at each study visit (screening to follow-up) · Course of pruritus (measured by VAS): absolute change in the pruritus score from baseline to EOT, and from EOT to the follow-up visit;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are included in the description of endpoints in E.5.2.	—

Measure

Time frame

Secondary end point(s): Secondary efficacy endpoints are: · s-ALP at each study visit (screening to follow-up) · ?-GT, AST, ALT and serum bilirubin levels at each study visit (screening to follow-up) · Course of pruritus (measured by VAS): absolute change in the pruritus score from baseline to EOT, and from EOT to the follow-up visit;Timepoint(s) of evaluation of this end point: Timepoints of evaluation are included in the description of endpoints in E.5.2.

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Countries

Austria, Belgium, Denmark, Finland, Germany, Hungary, Lithuania, Netherlands, Norway, Spain, Sweden, United Kingdom

Contacts

Public ContactDept. of Clin. Res. & Development

Dr. Falk Pharma GmbH

zentrale@drfalkpharma.de+4976115140

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026