Eosinophilic Esophagitis
Eosinophilic Esophagitis (EoE) is caused by elevated levels of a type of white blood cell called eosinophils in the oesophagus (the tube from the throat to the stomach). Elevated levels of eosinophils and a protein made by the body called Thymic Stromal Lymphopoietin (TSLP) cause inflammation of the oesophagus.
Tezepelumab is a man-made antibody that works by blocking the effects of TSLP. Antibodies are proteins naturally produced by the body to neutralize foreign substances that enter the body. By blocking the effects of TSLP, tezepelumab may help decrease inflammation in the oesophagus and improve difficulties in swallowing.
We are doing this study to learn more about tezepelumab. We would like to know if it could be an effective and safe treatment for EoE. We also aim to better understand the condition and associated health problems.
- Category
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Trial status
Recruiting
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Trial phase
Phase 3 Drug TrialLate stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
- Registry listing
Trial contact details
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Contact person
IBD Clinical Trials Unit
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Phone
07 3163 8195
What you need to know
Who can take part?
- Participants aged 12 -80
- Body weight ≥ 40 kg
- Confirmed diagnosis of Eosinophilic Eosophagitis
- Difficultly swallowing
- Prior treatment with standard medications
- Stable diet for at least 8 weeks
Exclusions
- Certain other diseases may exclude you from participating
- Strictures
- People requiring a feeding tube may not participate
- Current or recent infection
- Immunosuppression
- Previous cancer diagnosis
- Certain medications may make you ineligible to participate
What is involved for you?
- Medical history and collection of demographic information
- Vital signs
- Electrocardiogram
- Physical exam
- Blood and urine tests
- Pregnancy tests for women with childbearing potential
- Endoscopy with oesophagus tissue biopsy
- Daily diary completion
- Questionnaires
- Two injections every 4 weeks of treatment/placebo
Trial dates
April 2022 to December 2023
