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

3 1 1

What is this study about?

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.

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 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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
Universitetssykehuset Nord-Norge HF Tromsø Norway
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Hospital General Universitario Gregorio Maranon Madrid Spain
Klinikum Wels-Grieskirchen GmbH Wels Austria
AZ Sint-Lucas & Volkskliniek Gent Belgium
Univerzitna Nemocnica Martin Martin Slovakia
Hospital Universitario Infanta Leonor Madrid Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Athens Naval Hospital Athens Greece
424 Military General Training Hospital Thessaloniki Greece
NU Hospital Group-Vaestra Goetalandsregionen Trollhattan Sweden
Azienda Ospedaliera di Padova Padua Italy
Virgen del Rocío University Hospital Sevilla Spain
Odense University Hospital Odense Denmark
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Brno Brno Czechia
Sint-Lucas General Hospital Brugge Belgium
Turku University Hospital Turku Finland
Universita’ Di Pisa Pisa Italy
Aalborg University Hospital Aalborg Denmark
Hepato-Gastroenterologie HK s.r.o. Hradec Kralove Czechia
Hospital General De Tomelloso Tomelloso Spain
Region Sjaelland Holbæk Denmark
Huxfhxkb Usdcwcdvcratg Dv Ls Ppyrhwbg Madrid Spain
Layds Gcnocnv Haqiamgp Ov Atjkjx Athens Greece
Apspztciu Usj Amsterdam The Netherlands
Arhsuchn Umfccrcfll Hzxkyzlv Lorenskog Norway
Ubvokwk Uqjxfojkdo Hqsjwsnb Uppsala Sweden
Smitrsbrr Rvurgxk Unaftznrtb Mpdejjz Cjiwcg Nijmegen The Netherlands
Halhmxgr Uodfbrdfkz Cbfjtnm Hucxnfqx Helsinki Finland
Mkmfrlz Uerqyacead On Guig Graz Austria
Ezuovzx Ursygsqjabcu Mzyxeea Cxxbnjd Rcawwlxgl (ickqyby Mmw Rotterdam The Netherlands
Arsyxjz Uxlnp Syuiehbds Lamamp Dr Bkknnmx Bologna Italy
Hinge Mclgg Ot Rsczjkv Ht Aalesund Norway
Udlstnpyvt Oq Alofesx Edegem Belgium
Uctlltwhss Dcynz Sllmo Dt Rgid Ld Svoerigj Rome Italy
Hpxxhrtw Vcfs dykoxpwl Barcelona Spain
Udoiagakkz Gjpqltx Hatszqbl Akckaft Athens Greece

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
25.03.2024
Belgium Belgium
Not recruiting
25.03.2024
Czechia Czechia
Not recruiting
25.03.2024
Denmark Denmark
Not recruiting
25.03.2024
Finland Finland
Not recruiting
25.03.2024
Germany Germany
Not recruiting
25.03.2024
Greece Greece
Not recruiting
25.03.2024
Italy Italy
Not recruiting
25.03.2024
Norway Norway
Not recruiting
25.03.2024
Slovakia Slovakia
Not recruiting
25.03.2024
Spain Spain
Not recruiting
25.03.2024
Sweden Sweden
Not recruiting
25.03.2024
The Netherlands The Netherlands
Not recruiting
25.03.2024

Trial locations

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.

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 ID:
2023-504277-20-00
Protocol code:
CROSSING
NCT ID:
NCT05583227
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Study on BP1.7881 for Adults with Eosinophilic Esophagitis

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    France Italy
  • Study on Budesonide Tablets for Treating Eosinophilic Esophagitis in Adults

    Recruiting

    3 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Germany Portugal Spain