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Clinical Trials for Eosinophilic Oesophagitis

There are currently 9 ongoing clinical trials investigating new treatments for eosinophilic oesophagitis, a chronic inflammatory condition where white blood cells build up in the esophagus, causing difficulty swallowing. These trials are testing various medications including oral tablets, injections, and liquid formulations across multiple European countries. (Also known as: EoE, Eosinophilic Esophagitis)

Clinical trial locations

Study on BP1.7881 for Adults with Eosinophilic Esophagitis

This trial is evaluating BP1.7881A, a new medication taken as an orodispersible tablet that dissolves in the mouth. The study is designed to assess how effective and safe BP1.7881A is in treating adults with active symptoms.

Inclusion criteria: Participants must be 18 years or older and have experienced symptoms such as difficulty swallowing for at least four weeks before screening. They must have a confirmed diagnosis at screening and be willing to undergo necessary procedures including esophagogastroduodenoscopies with biopsies. Women of childbearing potential must use highly effective birth control during the trial and for one month after stopping the medication.

Exclusion criteria: Individuals without the condition cannot participate. The trial excludes certain age groups and vulnerable populations who may have limited ability to give informed consent or are at higher risk of harm.

Trial focus: The main goal is to observe changes in the number of eosinophils in the esophageal tissue through biopsies. The study also tracks improvements in symptoms such as difficulty swallowing and related issues. Participants will complete questionnaires and undergo endoscopic procedures over a 12-week treatment period.

Investigational drug: BP1.7881A is being studied for its potential to reduce inflammation in the esophagus caused by eosinophil buildup. This medication aims to decrease the number of these white blood cells in esophageal tissue, potentially improving symptoms like difficulty swallowing and food impaction.

Study on Budesonide Tablets for Treating Eosinophilic Esophagitis in Adults

This study is testing budesonide orodispersible tablets, which dissolve in the mouth. The trial compares two dosing schedules: taking 2 mg once daily versus 1 mg twice daily to determine if both schedules are equally effective in reducing inflammation in the esophagus.

Inclusion criteria: Participants must be between 18 and 75 years old, have a confirmed diagnosis with active symptoms, and score at least 4 points in the Patient’s Global Assessment measuring symptom severity at the start of the study.

Exclusion criteria: Only individuals 18 years or older with a confirmed diagnosis can participate. Vulnerable populations requiring special protection are excluded.

Trial focus: The primary focus is achieving histological remission, meaning reducing inflammation to levels not detectable under a microscope. Secondary aspects include monitoring changes in symptoms like difficulty swallowing and pain when swallowing. The study lasts six weeks with regular assessments of symptom severity.

Investigational drug: Budesonide is a corticosteroid designed to reduce inflammation in the esophagus. The tablets dissolve in the mouth, allowing the medication to coat the esophagus and reduce eosinophil levels.

Study on the Effects of EP-104IAR and Tetracosactide for Adults with Eosinophilic Esophagitis

This trial is testing EP-104IAR, which contains the active substance fluticasone propionate. The medication is given as an injection and is being evaluated for its safety, how the body processes it, and its effectiveness in treating the condition.

Inclusion criteria: Adults between 18 and 75 years old can participate if they have symptoms including a Symptom Dysphagia Index score of 5 or more and a confirmed past diagnosis with more than 15 eosinophils per high power field. Women of childbearing potential must have a negative pregnancy test and agree to use highly effective birth control during the study.

Exclusion criteria: Patients with other serious health conditions, those who are pregnant or breastfeeding, recent participants in other trials, those with allergies to the study medication, patients unable to follow procedures, and those with a history of drug or alcohol abuse cannot participate.

Trial focus: The study aims to determine the safety and tolerability of EP-104IAR, understand how the body processes the medication, and evaluate its effectiveness in treating symptoms. Participants will be monitored over time at weeks 2, 4, 8, 12, 24, and up to week 52 for some, with regular check-ups to measure medication levels in the blood and assess overall health.

Investigational drug: EP-104IAR contains tetracosactide and fluticasone propionate. It is administered as a suspension for injection with dosage and frequency determined by the study protocol.

Study on the Use of Viscous Budesonide for Children with Eosinophilic Esophagitis

This study focuses on children and adolescents, testing a new viscous formulation of Budesonide. This special formulation is designed to be thicker and stickier, helping the medication stay in the esophagus longer for improved effectiveness.

Inclusion criteria: Children between 4 and 18 years old with a confirmed diagnosis showing more than 15 eosinophils per high power field in esophageal biopsies can participate. Participants should not have responded to treatment with proton pump inhibitors or had a flare-up after stopping these medications. Written consent from a parent or legal representative is required, along with verbal consent from the child. Females of childbearing age must have a negative pregnancy test and agree to use contraception during the study.

Exclusion criteria: Patients without a diagnosis, those not within the 2 to 18 years age range, those unable to swallow the medication, those with interfering medical conditions, current participants in other trials, recent surgery patients, those allergic to study medication ingredients, pregnant or breastfeeding patients, and those with a history of non-compliance with medical treatments cannot participate.

Trial focus: The study evaluates how well this viscous form of Budesonide works in reducing eosinophils and improving symptoms over 12 weeks. Researchers monitor for any side effects and adverse events. The goal is to see if this new formulation can effectively reduce symptoms and inflammation in young patients.

Investigational drug: Budesonide is a corticosteroid that reduces inflammation. The viscous suspension form is designed to coat the esophagus, helping alleviate symptoms and reduce inflammation caused by allergic reactions.

Study on Etrasimod Arginine for Patients with Ulcerative Colitis, Alopecia Areata, Atopic Dermatitis, and Eosinophilic Esophagitis

This trial is testing Etrasimod Arginine in the form of mini tablets that can be mixed with different foods or water. The study investigates how the body absorbs the medication when mixed with various foods like applesauce, chocolate pudding, yogurt, or water, and evaluates taste preferences.

Inclusion criteria: Participants must be at least 18 years old and in good health as determined by medical evaluation, including physical exam, blood pressure and pulse measurement, clinical laboratory tests, and electrocardiogram. Body mass index must be between 16 to 32 kg/m² and total body weight greater than 50 kg. Participants must be willing and able to comply with all scheduled visits and procedures and provide signed informed consent.

Exclusion criteria: Patients with immune-mediated inflammatory disorders, those outside the specified age range, and vulnerable populations needing special protection cannot participate.

Trial focus: The study aims to understand the best way to deliver the medication by evaluating absorption rates and taste when mixed with different foods. Participants take a single dose of mini tablets in different forms, and researchers compare how the body absorbs the medication in each case. This includes monitoring plasma levels, heart rate, adverse effects, and vital signs.

Investigational drug: Etrasimod is a sphingosine-1-phosphate receptor modulator that helps control the movement of immune cells in the body. It is being studied for treating immune-mediated inflammatory disorders by modulating the immune system to reduce inflammation.

Study on Long-Term Safety of Cendakimab for Adults and Adolescents with Eosinophilic Esophagitis

This study evaluates the long-term safety of Cendakimab (CC-93538), given as a solution for injection under the skin. The trial focuses on how safe and tolerable the medication is when used over an extended period.

Inclusion criteria: Participants must have completed a previous related study and meet specific conditions regarding severe flare-ups or study completion phases. They must have followed required dosing in previous studies without permanent discontinuation and not experienced significant negative reactions preventing further treatment. Females of childbearing potential must have a negative pregnancy test and agree to use highly effective birth control until 5 months after the last dose. Participants must be 18 years or older and sign a consent form. In certain countries, patients under 18 will not be enrolled.

Exclusion criteria: Patients with other serious health conditions, current participants in other trials, recent surgery patients, pregnant or breastfeeding women, those with severe allergic reactions history, those unable to follow procedures, those who used certain interfering medications, and those with drug or alcohol abuse history cannot participate.

Trial focus: The study monitors long-term safety and tolerability, checking for adverse events, changes in vital signs, and laboratory test results. It also assesses the presence of anti-drug antibodies to understand the body’s immune response. The study continues until August 2026 with regular assessments throughout.

Investigational drug: CC-93538 is a monoclonal antibody administered as an injection, currently under investigation for its long-term safety. It targets specific pathways involved in the inflammatory process, helping reduce esophageal inflammation.

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

This trial tests tezepelumab, given as a subcutaneous injection. The study compares tezepelumab to a placebo to evaluate improvements in symptoms and reduction of inflammation in the esophagus.

Inclusion criteria: Participants must be between 12 and 80 years old, weigh at least 40 kg, have a confirmed diagnosis with esophageal intraepithelial eosinophilic infiltration of 15 or more per high power field, and experience difficulty swallowing at least twice weekly. They must maintain a stable diet for at least 8 weeks before and during the study. Participants can continue taking medications like proton pump inhibitors or swallowed topical corticosteroids if these have been stable for at least 8 weeks. They must have previously tried standard treatments.

Exclusion criteria: Patients with other significant health conditions, current participants in other trials, recent surgery patients, pregnant or breastfeeding women, those with severe allergic reactions history, those unable to follow procedures, those who used certain medications, those with drug or alcohol abuse history, certain cancer diagnoses, or known infections cannot participate.

Trial focus: The study evaluates how tezepelumab affects the esophagus, monitoring symptom improvements and inflammation changes over a 24-week treatment period, with an extended phase up to 52 weeks. The primary goal is achieving reduction in eosinophil count and improvement in swallowing difficulties.

Investigational drug: Tezepelumab is a monoclonal antibody that blocks a specific protein involved in the immune response, helping reduce inflammation and symptoms. It is administered as a subcutaneous injection at regular intervals.

Study on the Effectiveness and Safety of Barzolvolimab in Adults with Active Eosinophilic Esophagitis

This study evaluates Barzolvolimab (CDX-0159), a humanized immunoglobulin G1 kappa monoclonal antibody. The treatment is designed to target and reduce certain cells in the esophagus that contribute to the disease.

Inclusion criteria: Participants must have provided written informed consent, be 18 years or older, have a documented diagnosis confirmed by endoscopy, have esophageal intraepithelial eosinophilic infiltration of 15 or more per high power field, experience difficulty swallowing solid foods at least two days per week, maintain a stable diet for at least two months, and have had inadequate response to or be unsuitable for standard treatments.

Exclusion criteria: Patients with other serious health conditions, current participants in other trials, recent surgery patients, those unable to follow procedures, those with medication allergies, pregnant or breastfeeding women, those with substance abuse history, certain infections, certain cancer diagnoses, or severe allergic reactions history cannot participate.

Trial focus: The study assesses how well Barzolvolimab reduces specific cells in the esophagus and ensures safety. Participants receive treatment through subcutaneous injections over several weeks and are monitored for condition changes and side effects. The primary measure is the absolute change in peak esophageal intraepithelial mast cell count from baseline to week 12.

Investigational drug: Barzolvolimab is a monoclonal antibody administered via injection, designed to target specific pathways that regulate mast cell activity, aiming to decrease inflammation and reduce mast cell infiltration in the esophagus.

Title: Study of Solrikitug compared to placebo for adults with Eosinophilic Esophagitis to evaluate its effectiveness and safety

This trial tests Solrikitug, given through subcutaneous injection, comparing it with a placebo to determine effectiveness in treating inflammation and swallowing difficulties. The study consists of two parts: the first evaluates effectiveness in reducing inflammation and improving swallowing, while the second focuses on long-term safety.

Inclusion criteria: Participants must be between 18 and 75 years old, weigh at least 40 kg, have a confirmed diagnosis before or during screening, have experienced difficulty swallowing weekly in the 4 weeks before screening, have previous treatment with proton pump inhibitors (waiting at least 3 days if stopping), stop swallowed topical corticosteroids at least 8 weeks before screening if previously treated, maintain a stable diet for at least 8 weeks, and continue any standard treatments with unchanged dosage for at least 8 weeks. Dupilumab cannot be used during the study.

Exclusion criteria: Patients with autoimmune disorders, recent systemic corticosteroid use, active gastrointestinal infections or other conditions, major gastrointestinal surgery history, current or recent cancer, severe liver disease, pregnant or breastfeeding women, recent trial participants, those with medication allergies, immunocompromised patients, those with significant heart/kidney/lung disease, those unable to follow procedures, or those using prohibited medications cannot participate.

Trial focus: The study monitors participants over 52 weeks, with Part A lasting 24 weeks and Part B extending an additional 28 weeks. Regular assessments include tissue samples, monitoring of swallowing difficulties, laboratory tests, vital signs, heart recordings, and injection site checks. The goal is to evaluate reduction in esophageal inflammation and improvement in dysphagia.

Investigational drug: Solrikitug is an investigational medication currently in Phase 2 clinical trials being studied for its ability to reduce esophageal tissue inflammation and improve swallowing difficulties in adults. It is being evaluated in a randomized, double-blind, placebo-controlled study with an extension phase to assess long-term safety and effectiveness.

Study on BP1.7881 for Adults with Eosinophilic Esophagitis

This trial, already described above, is evaluating BP1.7881A in orodispersible tablet form for adults with active symptoms over a 12-week treatment period.

Summary

The nine ongoing clinical trials for eosinophilic oesophagitis represent diverse therapeutic approaches to managing this chronic inflammatory condition. Several trials focus on corticosteroid-based treatments, including budesonide in various formulations, demonstrating continued interest in optimizing this established treatment approach.

Geographically, Spain and Italy host the most trials, with six and five trials respectively, indicating strong research activity in Southern Europe. Germany, Belgium, and Poland also feature prominently with multiple trials. This distribution suggests robust research infrastructure and patient populations in these countries.

The trials employ different administration methods, from orodispersible tablets to subcutaneous injections, reflecting efforts to improve treatment convenience and effectiveness. Several studies focus specifically on monoclonal antibodies, representing newer targeted therapeutic approaches that aim to modulate specific immune pathways involved in the condition.

Notably, most trials focus on adult populations aged 18 and older, though one study includes children from age 4, and another includes adolescents from age 12. This highlights the need for age-appropriate treatment options across different life stages.

These trials collectively aim to expand treatment options, improve symptom management, and establish long-term safety profiles for both established and novel therapeutic approaches to eosinophilic oesophagitis.

Ongoing Clinical Trials on Eosinophilic oesophagitis

  • 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

  • Study on the Effects of EP-104IAR and Tetracosactide for Adults with Eosinophilic Esophagitis

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Study on Etrasimod Arginine for Patients with Ulcerative Colitis, Alopecia Areata, Atopic Dermatitis, and Eosinophilic Esophagitis

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium

  • Title: Study of Solrikitug compared to placebo for adults with Eosinophilic Esophagitis to evaluate its effectiveness and safety

    Not recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Belgium Italy The Netherlands Poland Spain

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