Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruitingRare disease

Study on Tezepelumab for Symptom Relief in Patients Aged 12-80 with Eosinophilic Esophagitis

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying eosinophilic esophagitis, a rare and chronic condition where the esophagus becomes inflamed due to an immune response to certain foods and airborne particles. This inflammation can cause difficulties in swallowing and other esophageal problems. The study will test the effects of a treatment called tezepelumab, which is given as an injection. Tezepelumab is being compared to a placebo to see how well it works in improving symptoms and reducing inflammation in the esophagus.

The purpose of the study is to evaluate how tezepelumab affects the esophagus in patients with eosinophilic esophagitis. Participants in the study will receive either tezepelumab or a placebo through a subcutaneous injection, which means the injection is given under the skin. The study will monitor changes in symptoms and the condition of the esophagus over time. Participants will be observed for improvements in their symptoms and any changes in the inflammation of their esophagus.

The study will last for a period of time, during which participants will receive regular injections and attend follow-up visits to assess their progress. The goal is to determine if tezepelumab can provide relief from the symptoms of eosinophilic esophagitis and improve the overall health of the esophagus. This research aims to offer new insights into the treatment of this condition and potentially improve the quality of life for those affected by it.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Screening

    The initial screening involves confirming eligibility based on age, weight, and a diagnosis of eosinophilic esophagitis (EoE).

    Participants must have a history of at least two episodes of difficulty swallowing per week in the four weeks prior to the screening.

    A stable diet and medication regimen must be maintained for at least eight weeks before the screening.

  2. Step 2

    Baseline Assessment

    Baseline assessments include measuring the severity of symptoms and conducting an esophageal biopsy to confirm the presence of EoE.

    Participants may continue their current medications for EoE, such as proton pump inhibitors (PPI) or swallowed topical corticosteroids (STC), as long as these have been stable for at least eight weeks.

  3. Step 3

    Randomization and Treatment Initiation

    Participants are randomly assigned to receive either tezepelumab or a placebo.

    The treatment involves a subcutaneous injection of Tezspire 210 mg solution, administered at regular intervals.

  4. Step 4

    Treatment Period

    The treatment period lasts for 24 weeks, during which participants receive regular injections.

    Participants are monitored for changes in symptoms and esophageal histology.

  5. Step 5

    Midpoint Evaluation

    At week 24, an evaluation is conducted to assess the histologic response and symptom improvement.

    The primary goal is to achieve a reduction in eosinophil count in the esophagus and improvement in swallowing difficulties.

  6. Step 6

    Extended Treatment Period

    Participants continue treatment for an additional 28 weeks, totaling 52 weeks of treatment.

    Further assessments are conducted to monitor long-term effects and safety.

  7. Step 7

    Final Evaluation

    At week 52, a final evaluation is performed to measure the overall effectiveness of the treatment.

    This includes assessing changes in eosinophil count, symptom scores, and any potential side effects.

Who can join the trial?

9 criteria

  • Participants must be between 12 and 80 years old at the time of signing the consent form.
  • Participants must weigh at least 40 kg (about 88 pounds) at the first visit.
  • Participants must have a confirmed diagnosis of eosinophilic esophagitis (EoE), which is a condition where certain white blood cells build up in the esophagus, causing inflammation. This diagnosis should be confirmed by a previous procedure called an EGD (a test that looks at the esophagus) and a biopsy (a small tissue sample).
  • Participants must have symptoms of EoE, such as having trouble swallowing (dysphagia) at least twice a week on average in the 4 weeks before the first visit.
  • Participants must follow a stable diet for at least 8 weeks before the first visit and during the study. This means no starting or stopping special diets that remove or add certain foods.
  • Participants can continue taking medications for EoE, like PPI (a type of medicine that reduces stomach acid) or STC (another type of treatment), as long as these medications have been stable for at least 8 weeks before the first visit. They should not change these medications or their doses unless necessary for medical reasons during the study.
  • Participants using medications for asthma or allergies, such as leukotriene inhibitors or steroids that are inhaled or taken through the nose, must have been on a stable dose for at least 4 weeks before the first visit.
  • If participants have stopped taking any medication for EoE, there should be a break of at least 8 weeks before the first visit. If they have stopped taking any biologic medication (a type of advanced treatment), there should be a break of 4 months or 5 times the medication's half-life, whichever is longer, before the first visit.
  • Participants should have previously tried standard treatments for EoE, which could include PPI, STC, or dietary changes.

Who cannot join the trial?

10 criteria

  • Patients who have other significant health conditions that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent surgery or plan to have surgery during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of severe allergic reactions.
  • Patients who are unable to follow the study procedures or attend study visits.
  • Patients who have used certain medications that might affect the study results.
  • Patients with a history of drug or alcohol abuse.
  • Patients who have been diagnosed with certain types of cancer.
  • Patients who have a known infection that could affect the study.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Tezepelumab is a medication being studied for its potential to help people with eosinophilic esophagitis, a condition where the esophagus becomes inflamed due to an excess of eosinophils, a type of white blood cell. This medication is being tested to see if it can reduce the number of eosinophils in the esophagus and improve symptoms like difficulty swallowing and food getting stuck. The study aims to determine if tezepelumab can make a significant difference in the health and comfort of patients with this condition.

What is already known about the treatment

Tezepelumab – Tezepelumab is administered as an injection under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating eosinophilic esophagitis, a rare inflammatory condition of the esophagus. The medication works by blocking a specific protein involved in the immune response, which helps reduce inflammation and symptoms associated with the condition. Tezepelumab is classified as a monoclonal antibody, a type of medication designed to target specific molecules in the body.

Investigated diseases

Eosinophilic Esophagitis – Eosinophilic esophagitis is a rare, chronic inflammatory disorder of the esophagus. It is triggered by an immune response to certain foods and airborne allergens. The condition is characterized by esophageal dysfunction, which can include difficulty swallowing, food impaction, and chest pain. The esophagus becomes inflamed due to the infiltration of eosinophils, a type of white blood cell. Over time, this inflammation can lead to the narrowing of the esophagus and the formation of strictures. The disease primarily affects both adults and children, with symptoms varying based on age.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504277-20-00Protocol codeCROSSINGEstimated enrolment360 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.