Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An Open Label, Phase 2 Study to Evaluate the Effect of A3907 on Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics in Adults with Primary Sclerosing Cholangitis (PSC)

This study is looking at a new medicine called A3907 for adults who have a liver condition called Primary Sclerosing Cholangitis, or PSC. It's a 'Phase 2' study, which means it's still in the early stages of testing. The main goal is to check how safe A3907 is and whether people can take it for 12 weeks without experiencing too many side effects. Researchers will also look at how the body handles the medicine and how it might affect numbers related to PSC, like certain liver tests. This research is important to understand if A3907 could be a helpful treatment in the future.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Albireo AB, Albireo AB

Enrolment target

Start

15 Dec 2022

Primary Sclerosing Cholangitis (PSC)

What is this study about?

This study is focusing on a condition called Primary Sclerosing Cholangitis, often shortened to PSC. PSC is a long-term liver disease that slowly damages the bile ducts, which are tubes that carry digestive fluid from the liver. There's currently no cure for PSC, so researchers are always looking for new ways to help manage it and improve patients' health.

Here, they are testing a new medicine called A3907. This is a 'Phase 2' study, meaning it's an early step in checking if a new medicine works and is safe. The top priority for the researchers is to understand if A3907 is safe for people to take and if they can tolerate it well over 12 weeks. This includes watching out for any unwanted side effects that might happen.

Beyond safety, the study also wants to learn how the body uses and gets rid of the medicine. They will also measure how A3907 affects certain substances in your blood and urine, including things related to how your liver is working. This information will help doctors understand if A3907 might be a good option for treating PSC in the future.

Key takeaways

This study is testing a new medicine (A3907) for PSC.
The main goal is to check its safety and if people can tolerate it.
It's an early-stage (Phase 2) clinical trial.
Participation involves taking the medicine and having regular check-ups for 12 weeks.
Adults aged 18 and over with PSC can be considered.

Who may be eligible?

To join this study, participants must be at least 18 years old. Both men and women can take part.

There will be other specific health requirements that aren't listed here. For example, you might need to have a confirmed diagnosis of PSC and your liver condition might need to be at a certain stage.

It's very important to discuss your full medical history with the study doctors to see if you meet all the criteria to safely participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a diagnosis of Primary Sclerosing Cholangitis (PSC)?
Are you able to attend regular clinic visits for 12 weeks?
Are you willing to take a new experimental medicine?

Answer every question to see your result.

What does participation involve?

If you join this study, you would primarily be taking the new medicine, A3907, for 12 weeks. During this time, you would have regular visits to the study clinic. These visits would likely involve taking blood and urine samples so doctors can check how your body is reacting to the medicine and monitor your liver function. They will also ask you questions about how you are feeling and if you are experiencing any side effects. The total length of your participation, including follow-up, would be discussed with you.

Potential risks and benefits

Potential benefits of taking part include contributing to medical research that could help others with PSC and potentially seeing an improvement in your own condition from the new medicine. However, there's no guarantee the medicine will help you, and you might experience side effects, some of which could be serious. All potential risks will be thoroughly explained before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Italy
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Unverified
France
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Unverified
Poland

Common questions

What is Primary Sclerosing Cholangitis (PSC)?

PSC is a long-term liver disease that damages the small tubes (bile ducts) in your liver, which can lead to liver problems over time.

What is A3907?

A3907 is a new medicine being tested in this study to see if it can help people with PSC. It's not yet approved for general use.

What does 'Phase 2 study' mean?

Phase 2 means it's an early research stage where doctors check if a new medicine is safe and if it shows any signs of working.

What are 'side effects'?

Side effects are any unwanted or unexpected reactions you might have to a medicine. The study will carefully record these.

Will I definitely get the new medicine?

In some 'Phase 2' studies, everyone gets the new medicine, but sometimes there's a comparison group. You should ask the study team about this.