You may be able to join the study if you meet the following requirements:
18 to 75 years old
Confirmed diagnosis of EoE
Must not have history or presence of other GI tract diseases (i.e. Celiac disease, Crohn’s disease)
18 to 75 years old
Confirmed diagnosis of EoE
Must not have history or presence of other GI tract diseases (i.e. Celiac disease, Crohn’s disease)
Other eligibility requirements will apply.
Participation in the ALAMERE study lasts about 72 weeks. Study participants can expect the following:
Participation in a clinical study is voluntary. You can ask any questions you have and may leave the study at any time, for any reason.
The investigational study drug, solrikitug, aims to improve symptoms and reduce difficulty swallowing caused by eosinophilic esophagitis (EoE). While there are other treatments available for EoE, solrikitug has potential to treat EoE closer to the source rather than just treating the symptoms. The study drug is administered as an injection under the skin.
Study participants in part A will receive either the study drug or placebo every 4 weeks. Participants are randomized into 4 groups in a 2:2:1:2 ratio, with the final group receiving placebo. This means that most participants will receive the study drug, and some participants will receive a placebo. Every participant who is eligible and continues to the Open-Label Extension period will receive the study drug.
A placebo looks like the study drug, but it does not contain any active drug. Some participants in the ALAMERE study will receive a placebo instead of the study drug. This lets researchers compare results across groups (placebo group compared to study drug group) to find out whether any results are from the study drug or from something else. Neither the participants nor the study team will know which group each participant was assigned to until after the study has ended.
Investigational means the drug is not approved by regulatory authorities like the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and it can only be used in clinical research studies like ALAMERE.
Eosinophilic esophagitis (EoE) is an inflammatory disease of the esophagus. The esophagus is the muscular tube that carries food and liquids from the mouth to the stomach. Individuals with EoE have white blood cells, called eosinophils, that build up in the lining of the esophagus which causes damage and inflammation. The longer this inflammation goes untreated, the more damage it can do to the esophagus over time.
EoE causes chronic dysphagia and food impaction. Dysphagia is a medical term for difficulty swallowing, and food impaction occurs when food becomes stuck in your esophagus.
The symptoms of EoE vary by patient age but commonly include the following:
Here are some common questions and answers about study participation.
Clinical research studies, or trials, help scientists and doctors explore whether a medical strategy, device, or medication is safe and effective for people. Before any medication can be approved and made available to the public, it must go through several phases of clinical research.
Before enrolling in a clinical trial, you must sign an Informed Consent Form (ICF). The ICF contains information about the study, including study goals, how long the study will last, benefits and risks, and the tests and procedures you will receive.
Study participation usually involves visiting a clinic regularly, taking or receiving an investigational medicine, and having assessments to monitor your health. You can still see your regular doctor, but you should let them know that you are participating in a study.
Participation in clinical research studies is your choice, and you may stop at any time.
If you have additional questions about participating in a clinical research study, contact a study clinic near you.
Use the filters, map, and listing to find the study clinic closest to you.
