Eosinophilic gastritis Trials in Disease

Study on the Safety and Effectiveness of Dupilumab for Adults and Adolescents with Eosinophilic Gastritis and Eosinophilic Duodenitis

This clinical trial is investigating dupilumab, a medication that may help reduce inflammation in the stomach and small intestine caused by an excess of eosinophils, a type of white blood cell. The study is designed to compare dupilumab with a placebo to determine whether it is safe and effective for treating adults and adolescents aged 12 years and older.

Who can participate:

• Males and females at least 12 years old (adolescents may only join in certain countries depending on local regulations)
• Must have a confirmed diagnosis of eosinophilic gastritis documented by a tissue sample taken at least 3 months before screening
• Must show signs of eosinophilic infiltration in the stomach lining on a baseline tissue sample
• Must have experienced at least 2 episodes of symptoms per week during the 8 weeks before screening
• Must complete an electronic diary tracking symptoms for at least 11 out of 14 days before the first visit
• Must have an average total symptom score of at least 20 and a severity score of at least 4 (on a scale of 0-10) for at least 2 of the 6 tracked symptoms in the 2 weeks before the first visit

Who cannot participate:

• Patients with other serious health conditions that might interfere with the study
• Patients currently participating in another clinical trial
• Patients who have had recent surgery or are planning surgery during the study
• Pregnant or breastfeeding women
• Patients with a history of severe allergic reactions to medications
• Patients unable to follow study procedures or attend study visits
• Patients with a history of drug or alcohol abuse
• Patients with certain infections that could affect study results
• Patients taking medications that might interfere with the study treatment
• Patients with conditions that doctors believe would make participation unsafe

Study focus and design:

The study is divided into three parts and lasts up to 52 weeks. Participants will receive either dupilumab (300 mg per injection) or a matching placebo through subcutaneous injections, meaning the medication is injected under the skin. The first part of the study, Part A, assesses the effect of dupilumab compared to placebo after 24 weeks by examining the condition of the stomach lining. Part B continues for another 24 weeks and evaluates both tissue-based and symptom-based improvements. Part C extends treatment up to 52 weeks to assess long-term safety and effectiveness.

Investigational drug:

Dupilumab is the medication being tested. It is a monoclonal antibody, a type of biologic medication that works by blocking specific proteins involved in the inflammatory response, namely interleukin-4 and interleukin-13. These proteins play a key role in the immune system's allergic and inflammatory reactions. By blocking them, dupilumab may help reduce inflammation and symptoms in the stomach and intestines.

Throughout the study, participants will undergo regular assessments to monitor changes in their symptoms and any side effects. This research aims to provide important information about whether dupilumab can be a useful treatment option for people living with eosinophilic gastritis and eosinophilic duodenitis.