Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Dose-finding, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Efavaleukin Alfa Induction Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis

This research study is about a new medicine called Efavaleukin Alfa for adults who have Ulcerative Colitis that is moderate to severe. Ulcerative Colitis causes inflammation in the large bowel, which can lead to symptoms like tummy pain and urgent trips to the toilet. This study aims to find the right dose of Efavaleukin Alfa to help people feel much better, possibly putting their condition into remission (a period where symptoms reduce or disappear). Researchers will also be checking to make sure the medicine is safe. Participants will be given either the new medicine or a dummy medicine (placebo) to see how well it works over 12 weeks.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Amgen Inc.

Enrolment target

167

Start

31 May 2024

Ulcerative Colitis (UC)

What is this study about?

This study is investigating a new medication called Efavaleukin Alfa as a potential treatment for Ulcerative Colitis (UC). Ulcerative Colitis is a long-term condition that causes inflammation and ulcers in the lining of the large bowel (colon and rectum). This can lead to symptoms like tummy pain, bloody stools, and needing to go to the toilet very often. When the condition is moderate to severe, it can have a big impact on daily life.

The main goal of this particular study is to find out how safe the new medicine is and if it can help people with UC achieve 'clinical remission' - meaning their symptoms significantly improve or disappear – after 12 weeks. Researchers will also be looking at other important aspects, such as whether the bowel lining itself shows signs of healing when viewed with a camera test (endoscopy), and if people generally feel better.

Finding new treatments is really important because not everyone with Ulcerative Colitis responds well to existing medications, or some people might experience side effects. This study aims to explore if Efavaleukin Alfa could be a new option to help more people with UC manage their condition effectively and improve their quality of life.

Key takeaways

This study is testing a new medicine (Efavaleukin Alfa) for moderate to severe Ulcerative Colitis.
It aims to find a safe and effective dose to help people achieve remission.
Participants will receive either the new medicine or a dummy medicine (placebo).
The main treatment period is 12 weeks, with regular clinic visits and assessments.
Joining a study has potential benefits and risks; you will get full details to help you decide.
You can stop participating at any point if you wish.

Who may be eligible?

To join this study, participants must be adults, aged 18 or older. Both men and women can take part. The study is specifically looking for people who have been diagnosed with Ulcerative Colitis that is currently considered moderate to severe, meaning their symptoms are significantly active.

There will also be some other medical requirements that need to be met. These usually involve looking at your overall health, any other medical conditions you might have, and medications you are currently taking. These checks help ensure that it's safe for you to take part and that the study results will be clear.

A doctor working on the study will carefully check your medical history and carry out some tests to confirm if you meet all the necessary criteria. This is to protect your safety and make sure the study gathers useful information.

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 been diagnosed with Ulcerative Colitis?
Is your Ulcerative Colitis currently moderate to severe?
Are you willing to attend regular clinic appointments for 12 weeks?
Are you able to provide informed consent (understand and agree to take part)?
Are you open to the possibility of receiving a placebo (dummy medicine)?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will be in it for a total of 12 weeks initially. During this time, you will receive either the new medicine (Efavaleukin Alfa) or a dummy medicine (placebo). You won't know which one you are getting, and neither will the study doctors. This helps to make sure the results are fair.

You can expect to have several appointments at the study clinic throughout these 12 weeks. These appointments will involve checking your symptoms, having physical examinations, providing blood and urine samples, and possibly having an endoscopy (a camera test to look at the lining of your bowel) to see how your condition is responding. All these tests and visits are designed to monitor your health and how the medicine is working. You will be given clear instructions on when and where to attend, and who to contact if you have any questions or concerns.

Potential risks and benefits

Taking part in a research study has potential benefits and risks. You might benefit from receiving a new medicine that could help your condition improve, or you might receive a dummy medicine which means your condition might not change or could worsen. There could be side effects from the new medicine, which the study team will carefully monitor. All medical procedures carry some small risks. You will be given much more detailed information about all possible benefits and risks before you decide to join. Remember, 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
Slovakia
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Unverified
Latvia
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Unverified
Finland
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Unverified
France
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Unverified
Czechia
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Unverified
Spain
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Unverified
Italy
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Unverified
Germany
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Unverified
Romania
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Unverified
Bulgaria
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Unverified
Belgium
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Unverified
Denmark

Common questions

What is Ulcerative Colitis?

Ulcerative Colitis is a long-term condition that causes inflammation and sores in the lining of your large bowel, leading to symptoms like tummy pain and urgent trips to the toilet.

What is a 'Phase 2' study?

Phase 2 means this is an early study to see if a new medicine works and is safe, usually in a small group of people. It helps find the right dose.

What does 'placebo-controlled' mean?

Some people in the study will get the new medicine, and others will get a 'dummy' treatment (placebo) that looks the same but contains no active medicine. This helps compare the effects.

How long will I be in the study?

The main part of the study where you receive treatment and are closely monitored will last for 12 weeks.

Can I leave the study if I change my mind?

Yes, you can choose to withdraw from the study at any time, for any reason, without it affecting your current or future medical care.