A Study Evaluating the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Primary Sclerosing Cholangitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-12-31

Brief Summary

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The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis

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Detailed Description

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The objectives of this study are to:

* Establish the safety and tolerability of once daily (QD) Aramchol meglumine in patients with PSC
* Examine whether once daily (QD) Aramchol meglumine has any effect on serum alkaline phosphatase
* Provide a comprehensive readout of clinical efficacy following once daily (QD) Aramchol meglumine administration

Conditions

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Primary Sclerosing Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel group analysis

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-blind

Study Groups

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PSC patients administered with Aramchol meglumine

Adult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine

Group Type ACTIVE_COMPARATOR

Aramchol meglumine

Intervention Type DRUG

Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)

PSC patients administered with placebo

Adult subjects with clinically diagnosed PSC that are administered with matching placebo

Group Type PLACEBO_COMPARATOR

Aramchol meglumine

Intervention Type DRUG

Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)

Interventions

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Aramchol meglumine

Aramchol meglumine is derived from a weak acid (Aramchol) and an amino-sugar (meglumine)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male or female age 18 years and above (inclusive at first screening visit)
2. Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
3. Alkaline phosphatase \> 150 IU/l
4. Stable inflammatory bowel disease therapy \> 3months for IBD patients
5. If receiving treatment with Ursodeoxycholic acid (UDCA; ursodiol), therapy is at a dose of \<20 mg/kg/day, has been stable for at least 6 months before screening
6. Ability to understand the nature of the study and to sign a written informed consent form (ICF)

Exclusion Criteria

1. Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
2. Active Crohn's disease (CDAI \> 40) or ulcerative colitis (Mayo IBD score \> 4) or active non-hemorrhoidal rectal bleeding
3. Small bowel resection \> 100 cm
4. Cirrhosis (clinically evident or by biopsy)
5. Prior hepatic decompensation event
6. Recent (\< 6 weeks) acute cholangitis or hospitalization for PSC or IBD
7. Bleeding diathesis or other contraindication for liver biopsy
8. Known GI or hepatobiliary malignancy
9. Prior liver transplantation
10. Prior exposure to study drug
11. Active untreated viral hepatitis or other concomitant liver disease

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No