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Active not recruitingPHASE3INTERVENTIONAL

Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis

This research study is investigating an experimental medicine called Tezepelumab for Eosinophilic Oesophagitis (EoE), a long-term condition where a type of white blood cell, eosinophils, build up in the gullet, causing inflammation and difficulty swallowing. The study is for people aged 12 to 80 and will compare Tezepelumab injections to a placebo (dummy treatment) to see how well it works and if it's safe. Participants will receive their treatment under the skin using a pre-filled syringe. The study will last for about a year with an option to continue for longer and includes follow-up care. The main goal is to find out if Tezepelumab can help improve the symptoms and impact of EoE.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
368
Start
10 Nov 2022
Estimated completion
23 Mar 2027

What is this study about?

This study is exploring a new treatment called Tezepelumab for a condition called Eosinophilic Oesophagitis, often shortened to EoE. EoE is a chronic allergic condition where a specific type of white blood cell, called eosinophils, builds up in the lining of the gullet (oesophagus). This can cause inflammation and damage, making it hard to swallow food and potentially leading to other uncomfortable symptoms.

The main purpose of this study is to find out if Tezepelumab is an effective and safe treatment for EoE in adults and adolescents aged 12 to 80. Participants will be randomly assigned to receive either Tezepelumab or a placebo (a dummy treatment that looks just like the real medicine but contains no active ingredients). This is a common way to test new medicines fairly, so researchers can accurately compare the effects of the new drug against not receiving the drug.

The study involves giving the medicine as an injection under the skin using a pre-filled syringe. By carefully observing participants, researchers hope to understand if Tezepelumab can help reduce the inflammation in the gullet, ease swallowing difficulties, and improve the overall well-being of people living with EoE.

Key takeaways

  • The study is investigating a new medicine, Tezepelumab, for Eosinophilic Oesophagitis (EoE).
  • It aims to assess how well Tezepelumab works and if it is safe, compared to a dummy treatment (placebo).
  • Participants will receive the study medicine or placebo as injections under the skin.
  • The core treatment period lasts for about one year, with potential for an extension.
  • You must have a confirmed EoE diagnosis and experience swallowing difficulties.
  • Regular health checks and monitoring will be part of your participation.

Who may be eligible?

To join this study, participants must be between 12 and 80 years old and weigh at least 40 kg. You must have a confirmed diagnosis of EoE, meaning it has been identified through a previous examination and biopsy of your gullet.

You should be experiencing symptoms of EoE, specifically having difficulty swallowing (food feeling stuck or going down slowly) at least twice a week in the month leading up to the study. It's important that your diet has been stable for at least 8 weeks before starting the study and remains consistent throughout.

If you are currently taking other medications for EoE, asthma, or allergies, these generally need to have been on a stable dose for a certain period before the study begins. The team will review all your medical history and current treatments to ensure it's safe and appropriate 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.

  1. Are you between 12 and 80 years old?
  2. Have you been diagnosed with Eosinophilic Oesophagitis (EoE) by a doctor?
  3. Do you experience difficulty swallowing (food getting stuck or going down slowly) at least twice a week?
  4. Have you maintained a stable diet for at least 8 weeks?
  5. Are any other medications you take for EoE, asthma, or allergies on a stable dose?
Answer every question to see your result.

What does participation involve?

If you join this study, it will involve a screening period of 2 to 8 weeks to determine if you are suitable. Once eligible, you will enter a main treatment period lasting 52 weeks (about a year). During this time, you will receive injections under your skin, either the study medicine (Tezepelumab) or a placebo, at regular intervals. You won't know which one you are receiving.

After the 52-week treatment, you may have the option to continue receiving the active medicine for an additional 24 weeks in an 'extension period'. No matter whether you join the extension or not, there will be a 12-week safety follow-up period without treatment, where researchers will check in on your health. Throughout the study, you will have regular clinic visits, assessments, and tests to monitor your health and how the treatment is working. Approximately 360 people will take part in this study, with an equal chance of being assigned to one of three groups.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing an investigational treatment for your condition that is not yet widely available. While the specific benefits of Tezepelumab for EoE are being studied, there is a hope that it could help reduce your symptoms and improve your quality of life. However, like all medicines, Tezepelumab could have side effects, and some may be unexpected. The research team will monitor you closely for any adverse effects, and you will be fully informed of known potential risks. It's important to remember that you have the right to withdraw from the study at any time, for any reason, without it affecting your usual care.

Locations (125)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Phoenix, United States
  • Research Site
    Verified postcode
    Little Rock, United States
  • Research Site
    Verified postcode
    Los Angeles, United States
  • Research Site
    Verified postcode
    Aurora, United States
  • Research Site
    Verified postcode
    Inverness, United States
  • Research Site
    Verified postcode
    Jacksonville, United States
  • Research Site
    Verified postcode
    Saint Augustine, United States
  • Research Site
    Verified postcode
    Normal, United States
  • Research Site
    Verified postcode
    Iowa City, United States
  • Research Site
    Verified postcode
    Topeka, United States
  • Research Site
    Verified postcode
    White Marsh, United States
  • Research Site
    Verified postcode
    Boston, United States

Common questions

What is Eosinophilic Oesophagitis (EoE)?

EoE is an allergic condition where white blood cells called eosinophils build up in your gullet, causing inflammation and making it hard to swallow.

What is Tezepelumab?

Tezepelumab is an investigational medicine being tested to see if it can treat EoE symptoms by reducing the inflammation.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real medicine but contains no active ingredients. It helps researchers compare the real medicine's effects accurately.

How long will I be in the study?

The main treatment period is about one year (52 weeks), with an optional extension for another 24 weeks, followed by a 12-week safety check-up period.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor the study team will know which treatment you are receiving until the study is over.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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