Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Parallel-Group Treatment, Double-Blind, 2-Arm Study to Investigate the Comparative Efficacy, Safety, and Immunogenicity Between Intravenous AVT16 and Entyvio® in Male and Female Subjects Aged 18 to 80 Years Inclusive with Moderate to Severe Active Ulcerative Colitis

This research study is looking at two medicines, AVT16 and Entyvio®, for adults aged 18 to 80 who have moderate to severe ulcerative colitis. Ulcerative colitis is a long-term condition that causes inflammation in the large intestine. The study aims to see how effective these treatments are at reducing symptoms, how safe they are, and how a person's immune system responds to them over a full year. Participants will receive either AVT16 or Entyvio through an IV drip. Primarily, the researchers want to find out if there's a significant improvement in symptoms, especially bleeding, after just 6 weeks of treatment. They will also track progress over many months to see if the treatments lead to lasting symptom relief and healing inside the body.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Alvotech Swiss AG

Enrolment target

462

Start

20 Aug 2024

Moderate to Severe Active Ulcerative Colitis

What is this study about?

This study is like a detailed comparison between two medicines, AVT16 and Entyvio®, for people living with a bowel condition called ulcerative colitis. If you have moderate to severe ulcerative colitis, it means your large intestine is inflamed, causing symptoms like bleeding and discomfort. Researchers want to understand if AVT16 works as well as, or even better than, Entyvio®, which is an established treatment. This study is in the final stages of testing, often called 'Phase III,' which means it's a big step towards potentially making a new medicine available.

The main goal is to see if people feel better and their symptoms improve, especially bleeding, after 6 weeks of treatment. But the study won't stop there. They will continue to check on participants for a whole year to see how well the medicines work over time, if they help heal the lining of the bowel, and if they can lead to long-term relief from symptoms without needing steroids. They will also be looking closely at any side effects and how the body's immune system reacts to each medicine.

Ultimately, this research helps doctors and patients understand the best ways to manage ulcerative colitis. By comparing these treatments, the hope is to find safe and effective options that can improve the quality of life for many people living with this condition.

Key takeaways

This study compares two IV medicines, AVT16 and Entyvio, for moderate to severe ulcerative colitis.
It lasts for one year, with regular check-ups to monitor your health and symptoms.
It's a 'Phase III' study, meaning it's a crucial step in testing a new medicine.
The main aim is to see if symptoms improve significantly, especially bleeding, after 6 weeks.
Both men and women aged 18-80 can potentially join, if they meet other health criteria.
You will be closely monitored for any side effects and how your body responds to the treatment.

Who may be eligible?

To be considered for this study, you need to be an adult, specifically between 18 and 80 years old. Both men and women are welcome to participate. The study is specifically for individuals who have been diagnosed with ulcerative colitis that is considered 'moderate to severe' and is causing active symptoms.

There might be other health conditions or medications that would prevent someone from joining, even if they meet the age and condition requirements. For example, if you have certain other illnesses or are taking specific drugs, it might not be safe to join. All these details would be carefully checked by the study doctor.

It's important to remember that meeting these basic requirements doesn't guarantee a place in the study. A study doctor will need to do a full health check and review your medical history to make sure the study is a good fit for you and that it's safe for you to take part.

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 between 18 and 80 years old?
Have you been diagnosed with moderate to severe ulcerative colitis?
Are you experiencing active symptoms of your condition?
Are you able to attend regular clinic visits for one year?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the investigational medicine AVT16 or the standard medicine Entyvio® through an IV drip. This means the medicine will be slowly given into a vein, usually in your arm. You'll have regular visits to the clinic over a period of 52 weeks, which is about one year.

During these visits, the study team will monitor your health very closely. This will involve physical examinations, blood tests, urine tests, and checking your vital signs like your blood pressure and heart rate. They'll also ask you about your symptoms and how you're feeling. Some visits might include specific checks of your bowel health to see if the medicine is helping to heal the inflammation. The study will track how your body responds to the medicine and any side effects you might experience. The exact number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from receiving a new treatment like AVT16, which could improve your ulcerative colitis symptoms. You would also receive very close medical attention and monitoring throughout the study. However, there's always a chance that the new medicine might not work for you, or it could cause side effects. Entyvio®, the comparison medicine, also has known side effects, which the study team will discuss with you. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (11)

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

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Unverified
Croatia
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Unverified
Latvia
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Unverified
Slovakia
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Unverified
Bulgaria
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Unverified
Poland
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Unverified
Romania
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Unverified
Spain
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Unverified
Greece
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Unverified
Hungary
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Unverified
Czechia
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Unverified
Italy

Common questions

What is ulcerative colitis?

Ulcerative colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops tiny ulcers, leading to symptoms like tummy pain, bloody stools, and needing to go to the toilet urgently.

What does 'moderate to severe' mean?

It means your ulcerative colitis symptoms are significant and impacting your daily life, and your doctor believes you need treatment beyond basic medications to control the inflammation.

What's the difference between AVT16 and Entyvio?

Entyvio is a medicine already approved and used for ulcerative colitis. AVT16 is a new medicine being tested to see if it works similarly to or better than Entyvio. They both work by reducing inflammation in the gut.

What are 'IV infusions'?

An IV infusion means the medicine is given slowly into a vein, usually in your arm, using a drip. This is a common way to give certain medications so they can get into your system quickly.

What happens if I want to stop taking part?

You are free to leave the study at any time, for any reason. You don't have to explain why, and it won't affect your future medical care. Just let the study team know.