Not recruitingRare disease

Study on the Safety and Tolerability of A3907 for Adults with Primary Sclerosing Cholangitis (PSC)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a liver disease called Primary Sclerosing Cholangitis (PSC). PSC is a condition where the bile ducts inside and outside the liver become inflamed and scarred, which can lead to liver damage over time. The study is testing a new treatment called A3907, which is taken as a film-coated tablet. The purpose of the study is to evaluate how safe and tolerable A3907 is for adults with PSC, both with and without a condition known as a Clinically Relevant Stricture (CRS), which is a significant narrowing of the bile ducts.

Participants in the study will take the medication orally for a period of 12 weeks. During this time, researchers will monitor the participants to see how their bodies respond to the treatment. This includes checking for any side effects and measuring various health indicators, such as liver function and bile acid levels in the blood and urine. The study aims to gather information on how the body processes the medication and its effects on the liver and bile acids.

The study is open-label, meaning both the participants and the researchers know which treatment is being administered. This trial is part of a Phase 2 study, which is an early stage of clinical research that focuses on assessing the treatment's safety and how well it is tolerated by patients. The results will help determine if A3907 is a viable treatment option for people with PSC and provide valuable insights into its potential benefits and risks.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Beginning of the trial
Upon joining the study, you will begin the trial by taking the medication A3907. This medication is provided in the form of a film-coated tablet and is taken orally.
The primary goal at this stage is to evaluate the safety and tolerability of the medication in individuals with primary sclerosing cholangitis (PSC).
Step 2
Medication administration
You will take the A3907 tablet as directed by the study team. The specific dosage and frequency will be provided to you, and it is important to follow these instructions carefully.
The treatment period lasts for 12 weeks, during which you will continue to take the medication as prescribed.
Step 3
Monitoring and assessments
Throughout the trial, regular monitoring will occur to assess your health and the effects of the medication. This includes checking for any treatment-emergent adverse events (TEAEs).
You will undergo various tests to measure changes in serum and urine bile acid levels, liver transaminases (such as ALT and AST), and other relevant health markers.
Step 4
End of treatment
At the end of the 12-week treatment period, a final assessment will be conducted to evaluate the overall impact of the medication on your condition.
The study team will review all collected data to determine the primary endpoint, which focuses on the safety and tolerability of the medication.

Who can join the trial?

15 criteria

Adults between 18 and 75 years old.
Have a clinical diagnosis of large-duct Primary Sclerosing Cholangitis (PSC) for more than 6 months, confirmed by specific imaging tests like MRCP or ERCP, and past evidence of high alkaline phosphatase (ALP) levels.
Willing to sign an informed consent form.
Women who can have children and men with female partners who can have children must agree to use birth control. Women who cannot have children must meet specific criteria and have a certain hormone level.
Alkaline Phosphatase (ALP) levels must be more than 1.5 times the upper limit of normal but not more than 10 times the upper limit at the first visit. ALP levels should not vary by more than 30% between the first and second visits.
For certain study groups: Total bilirubin levels must be less than 1.5 times the upper limit of normal, unless due to specific conditions, and direct bilirubin must be normal.
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels must be no more than 5 times the upper limit of normal.
Serum bile acid levels must be above the upper limit of normal.
For certain study groups: An MRCP or similar imaging test within 6 months before the study must show PSC without a significant narrowing of the bile ducts.
For another study group: An MRCP or similar imaging test within 6 months before the study must show PSC with a significant narrowing of the bile ducts or bile duct blockage.
Use of ursodeoxycholic acid (UDCA) or bile acid-binding resins is allowed if the treatment has been stable for at least 3 months before the study and is expected to remain stable during the study, or if UDCA was stopped at least 3 months before the study.
If the patient has inflammatory bowel disease (IBD), it must be documented and in remission or mildly active. A colonoscopy within one year before the study must show no signs of dysplasia or cancer.
Must be clinically stable for at least 3 months before the study.
For another study group: Must have one stable significant narrowing of the bile duct for at least 4 weeks, confirmed by imaging, without suspicion of bile duct cancer or gallstones. Patients may have symptoms of worsening liver function and could be listed for liver transplantation due to the narrowing.
For another study group: MELD Score must be less than 35.

Who cannot join the trial?

10 criteria

Patients with other serious liver diseases cannot participate.
Patients who have had a liver transplant are not eligible.
Patients with a history of cancer in the last 5 years cannot join, except for some skin cancers that are not serious.
Patients who are pregnant or breastfeeding are not allowed to participate.
Patients who are currently participating in another clinical trial cannot take part.
Patients with a known allergy to the study medication or its ingredients cannot join.
Patients with severe heart problems are not eligible.
Patients with uncontrolled diabetes, which means their blood sugar levels are not stable, cannot participate.
Patients with severe kidney problems are not allowed to join the study.
Patients with any other condition that the study doctors think would make it unsafe for them to participate cannot join.

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Verified sites

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Verified
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
Verified
Azienda Ospedaliera di Padova
Padua, Italy
Responsive
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer
Barcelona, Spain

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Investigated drugs

A3907 is a medication being studied for its potential to help people with a liver condition called Primary Sclerosing Cholangitis (PSC). PSC is a disease that affects the bile ducts, which are small tubes that carry a digestive fluid called bile from the liver to the small intestine. In PSC, these bile ducts become inflamed and scarred, which can lead to liver damage over time. The purpose of this study is to see if A3907 is safe and well-tolerated by patients with PSC, and to understand how the body processes the medication. Researchers are also looking at how A3907 affects the body, which is known as pharmacodynamics. This study is important because it could lead to a new treatment option for people with PSC, especially those who have a condition called Clinically Relevant Stricture (CRS), which is a narrowing of the bile ducts that can cause additional complications.

A3907

What is already known about the treatment

A3907 – A3907 is an investigational medication currently being studied in a clinical trial for its potential use in treating Primary Sclerosing Cholangitis (PSC), a liver disease. It is administered orally, meaning it is taken by mouth in the form of a pill or capsule. The main goal of the ongoing study is to assess the safety and tolerability of A3907 in adults with PSC, both with and without a condition known as Clinically Relevant Stricture (CRS). While the exact mechanism of action at the molecular level is not detailed, the study aims to understand how the drug behaves in the body and its effects on the disease.

Investigated diseases

Primary Sclerosing Cholangitis (PSC) – Primary Sclerosing Cholangitis is a chronic liver disease characterized by inflammation and scarring of the bile ducts. Over time, the inflammation leads to the formation of scar tissue, which can cause the bile ducts to become narrowed or blocked. This obstruction impairs the flow of bile, a digestive fluid produced by the liver, leading to liver damage. As the disease progresses, it can result in liver cirrhosis, where the liver becomes severely scarred and its function is compromised. PSC is often associated with inflammatory bowel diseases, such as ulcerative colitis. The exact cause of PSC is unknown, but it is believed to involve immune system dysfunction.