A Study to Investigate the Efficacy and Safety of NSI-8226 in Adults With Eosinophilic Esophagitis
This clinical trial is looking into a new medicine called Solrikitug for adults who have Eosinophilic Esophagitis (EoE). EoE is a problem where a type of white blood cell, called eosinophils, builds up in the food pipe, causing swelling and difficulty swallowing. This study aims to find out if Solrikitug is safe and effective in treating these symptoms. Participants will receive either different doses of Solrikitug or a dummy medicine (placebo) alongside their usual care. The medicine is given as an injection. Researchers will observe participants for over a year to understand how the medicine works and if it has any side effects. This research helps us find better ways to manage EoE.
At a glance
What is this study about?
This study is about an illness called Eosinophilic Esophagitis, or EoE for short. EoE happens when certain white blood cells, called eosinophils, gather in your food pipe (esophagus). This causes swelling and can make it hard to swallow food properly, leading to discomfort.
Researchers are testing a new medicine, called Solrikitug, to see if it can help adults with EoE. The study wants to find out if this medicine is safe, how well it works, and what dose might be best. Some people in the study will get the new medicine, while others will get a 'dummy' medicine called a placebo. This helps the researchers understand the true effects of Solrikitug compared to not having the active medicine.
Finding new and better treatments for EoE is very important because current options don't work for everyone, or they might have side effects. This study is part of developing new ways to help people live more comfortably with EoE.
Key takeaways
- This study is for adults with Eosinophilic Esophagitis (EoE).
- It's testing a new medicine called Solrikitug, given by injection.
- You might receive Solrikitug or a dummy medicine (placebo).
- The study lasts over a year with regular clinic visits.
- It aims to find out if Solrikitug is safe and effective for EoE.
- Participation involves potential benefits and risks, and you can withdraw anytime.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old.
You must have a clear diagnosis of EoE confirmed by a doctor, including a previous endoscopy and biopsy. You should also be experiencing symptoms, such as difficulty swallowing, at least twice a week. If you're on a special diet or taking other medications for EoE, like PPIs, you should have been on a stable plan for at least 8 weeks before starting the study.
You can't join if you are pregnant or breastfeeding, or have certain other tummy or food pipe problems like Crohn's disease or severe narrowing of your food pipe. If you've had a procedure to stretch your food pipe recently, you might also not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 75 years old?
- Have you been officially diagnosed with Eosinophilic Esophagitis (EoE)?
- Do you get difficulty swallowing at least twice a week?
- Are your current EoE medications or diet stable for at least 8 weeks?
- Are you not pregnant or breastfeeding?
- Do you have no other serious stomach or food pipe conditions?
What does participation involve?
If you decide to take part, you'll be in the study for quite a while. First, there's a 24-week period where you'll receive either Solrikitug or a placebo through injections given at the study site. After that, there's an extra 28-week period, followed by a 16-week check-up phase. This means the study will involve regular visits to the clinic over a total of about 68 weeks (just over a year and a quarter). During these visits, the study team will monitor your health, ask about your symptoms, and may take blood samples or perform other assessments to see how you're responding to the treatment.
Potential risks and benefits
Locations (73)
- Research Site 1039Verified postcodeDothan, United States
- Research Site 1018Verified postcodeGlendale, United States
- Research Site 1018Verified postcodePeoria, United States
- Research Site 1037Verified postcodeScottsdale, United States
- Research Site 1003Verified postcodeTucson, United States
- Research Site 1023Verified postcodeEnglewood, United States
- Research Site 1005Verified postcodeIrvine, United States
- Research Site 1015Verified postcodeSan Diego, United States
- Research Site 1034Verified postcodeAurora, United States
- Research Site 1027Verified postcodeCromwell, United States
- Research Site 1040Verified postcodeInverness, United States
- Research Site 1001Verified postcodeJacksonville, United States
Common questions
What is Eosinophilic Esophagitis (EoE)?
EoE is a long-term condition where a type of white blood cell builds up in your food pipe, causing it to become inflamed and making it difficult and painful to swallow.
What is Solrikitug?
Solrikitug is a new medicine being tested to see if it can help reduce the inflammation and symptoms caused by EoE.
Will I definitely get the new medicine?
No, this is a 'blinded' study. You'll either receive one of the doses of Solrikitug or a dummy treatment (placebo). Neither you nor the study team will know which one you are getting.
How is the medicine given?
The medicine (or placebo) is given as an injection under the skin at the study clinic.
How long will the study last if I join?
If you participate, the main treatment period is 24 weeks, followed by an additional 28-week extension, and a 16-week follow-up. The total time for your involvement would be about 68 weeks.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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