Ongoing, recruitingTherapeutic use (Phase IV)Interventional

Postauthorization Safety Study of the Long-Term Safety and Efficacy of Repeat Administration of Darvadstrocel in Patients With Crohn’s Disease and Complex Perianal Fistula

This study, called a Phase IV trial, is designed for people living with Crohn's disease who have a specific problem: complex perianal fistulas. These are tunnels that form near the bottom and can be very uncomfortable. The research is specifically looking at a medicine called Alofisel. Doctors want to understand how safe this treatment is over a long period, especially when patients receive it more than once. They will also be checking how well it works to heal these fistulas. This type of study happens after a medicine is already approved, helping us learn more about its long-term effects and benefits in real-world use.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic use (Phase IV)

Sponsor

Takeda Development Center Americas Inc.

Enrolment target

Start

18 Dec 2023

Perianal fistulising Crohn´s disease

What is this study about?

This study is for people who have Crohn's disease and also suffer from something called complex perianal fistulas. Crohn's disease is a long-term condition that causes inflammation in the digestive system. Perianal fistulas are small tunnels that can develop from the bowel to the skin around the bottom, and they can be quite painful and lead to infection. This study is focused on a specific treatment called Alofisel.

The main goal of this research is to understand the long-term safety of Alofisel when it's given more than once. This means doctors will be carefully watching for any side effects or other health issues that might pop up during the study. They're also really keen to see how well the treatment helps these fistulas heal and whether they stay healed over time, looking for things like whether the openings close up and if any collections of fluid disappear.

Because this is a Phase IV study, it means the treatment, Alofisel, is already approved for use. This type of study helps doctors gather even more information about a treatment's safety and how well it works in a larger number of patients over a longer period, which helps us understand its benefits and any potential risks in typical use.

Key takeaways

The study is about a treatment called Alofisel for Crohn's disease patients with perianal fistulas.
It's looking at the long-term safety and how effective the treatment is, especially with repeated use.
The treatment is given by injection.
Participation involves regular clinic visits for checks and scans over several years.
This is a 'Phase IV' study, meaning the treatment is already approved but more long-term information is needed.

Who may be eligible?

To be able to take part in this study, you need to be an adult, aged 18 years or older. This study is open to both men and women.

More detailed checks will be done by the study team to make sure it's the right study for you, depending on your overall health and your specific Crohn's disease and fistula condition.

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 Crohn's disease?
Do you have complex perianal fistulas?
Are you able to commit to regular hospital visits over several years?

Answer every question to see your result.

What does participation involve?

If you join this study, you would receive the Alofisel treatment, which is given as an injection. The study will pay close attention to your health for a long time afterward, checking for any side effects and how your fistulas are healing. This will involve regular visits to the clinic for check-ups, where doctors might examine your fistulas and perhaps perform scans like an MRI to see how things are progressing inside. You’ll also be asked about your general health and any changes you notice. The study will likely involve follow-up for several years (up to 3 years or 156 weeks) to track the long-term effects.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from a new treatment for your condition. However, there's also a chance of experiencing side effects from the medication. The research team will explain all known risks to you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (5)

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

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Unverified
Austria
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Unverified
Spain
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Unverified
Czechia
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Unverified
France
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Unverified
Germany

Common questions

What are perianal fistulas?

These are small tunnels that connect the inside of your bowel to the skin around your bottom. They can cause discomfort and leakage.

What is Alofisel?

Alofisel is a specific medicine being studied to treat complex perianal fistulas in people with Crohn's disease.

Why is this study happening?

This study aims to discover more about the long-term safety and how well Alofisel works when given more than once to treat these fistulas.

Will I get this treatment if I join?

Yes, if you qualify for the study, you would receive the Alofisel treatment as part of the research.

How long will the study last for me?

The study involves long-term follow-up, which could last for several years, up to about 3 years (156 weeks).