Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Long-Term Extension (LTE) Study to Evaluate The Safety and Efficacy of Efavaleukin Alfa in Subjects With Moderately to Severely Active Ulcerative Colitis

This research is a continuation of an earlier study, focusing on a medicine called Efavaleukin Alfa for individuals living with moderate to severe ulcerative colitis. It's designed to observe what happens over a longer period, specifically 52 to 104 weeks (that's about one to two years). The main goal is to keep a close eye on any side effects that might pop up during treatment. We're also checking how well the medicine helps people feel better, how it affects the signs of the disease inside the body (like inflammation in the gut), and if it helps people stop needing other medicines like steroids. This helps us understand the medicine's long-term safety and how well it helps manage ulcerative colitis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Amgen Inc.

Enrolment target

Start

31 May 2024

Ulcerative Colitis (UC)

What is this study about?

This study is a long-term follow-up for people who have been taking a trial medicine called Efavaleukin Alfa for moderate to severe ulcerative colitis. Ulcerative colitis is a long-lasting condition where the lining of the large intestine (colon) becomes inflamed and develops tiny open sores, called ulcers. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. This particular study is called a 'Phase 2 Long-Term Extension' study, which means it continues to look at a medicine that's already shown some promise in earlier tests. It’s designed to give us a much better picture of how safe and helpful the medicine is over a longer period, specifically up to two years.

The main aim of this research is to carefully record any new or worsening health problems, often called 'side effects,' that people experience while taking Efavaleukin Alfa. Understanding these side effects is really important for working out if a new medicine is safe enough to be used more widely. Beyond safety, the study also measures how well the medicine helps control the ulcerative colitis. This includes seeing if symptoms improve, if the inflammation in the gut calms down when viewed by a doctor (through an endoscopy), and even if the gut tissue appears healthier under a microscope.

The findings from this study will help doctors and researchers understand if Efavaleukin Alfa could be a good long-term treatment option for people with ulcerative colitis. It’s all about finding new and better ways to help people live with this condition and improve their quality of life.

Key takeaways

This study is for adults with moderate to severe ulcerative colitis.
It’s a long-term follow-up for people who were already in an earlier study of Efavaleukin Alfa.
The main goal is to carefully check for any side effects of the medicine over a long period (up to two years).
Researchers will also look at how well the medicine helps control the disease symptoms and inflammation.
This research helps understand if Efavaleukin Alfa is safe and effective as a long-term treatment.

Who may be eligible?

To join this particular study, you would need to be at least 18 years old. There's no upper age limit, so adults of any age can be considered. The study is open to both men and women.

Crucially, this isn't a study for brand new participants. You must have already taken part in the previous main study for Efavaleukin Alfa (called Study 20170104) and completed it. This study is simply a continuation for those who have already started the treatment in the earlier trial.

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?
Have you previously taken part in the main Efavaleukin Alfa study (Study 20170104)?
Did you complete that previous study?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll continue to receive the study medicine, Efavaleukin Alfa. The main focus will be on your safety, so you'll have regular check-ups to monitor your health. These visits will likely include physical examinations, blood tests, and discussions about how you're feeling and any new symptoms or side effects you might be having. You might also have procedures like endoscopies, where a tiny camera is used to look inside your colon, to see how the disease is progressing. The study will continue for up to 104 weeks (about two years), with regular follow-up appointments throughout this time. You'll need to attend all scheduled visits to ensure your safety is monitored and the study collects complete information.

Potential risks and benefits

Participating in research studies like this helps advance medical science and could lead to new treatments for ulcerative colitis. You might benefit from closer monitoring of your condition and potentially continue receiving a medication that has shown some promise. However, all medicines have potential risks, including side effects, which this study is designed to carefully track. These side effects could be mild or, in rare cases, more serious. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (17)

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
Denmark
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Unverified
Finland
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Unverified
Slovakia
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Unverified
Italy
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Unverified
Romania
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Unverified
Hungary
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Unverified
Spain
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Unverified
Belgium
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Unverified
Poland
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Unverified
Germany
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Unverified
France

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-lasting condition where the large intestine (colon) becomes inflamed and develops open sores, causing symptoms like tummy pain and urgent bathroom trips.

What is Efavaleukin Alfa?

Efavaleukin Alfa is a new medicine being tested to see if it can help reduce inflammation and improve symptoms for people with ulcerative colitis.

What does a 'long-term extension' study mean?

It means this study is a continuation of an earlier one. People who were already taking the study medicine in the first trial can keep taking it for a longer time to see its effects over many months.

What kind of side effects are they looking for?

The study will track any new or worsening health problems you experience while taking the medicine. These could be mild, like a headache, or more serious, and will be carefully recorded by the study team.

How long will this study last?

This study is designed to last for up to 104 weeks, which is about two years, to see the long-term effects of the medicine.