A Sub Study to Learn About the Study Medication Called Etrasimod Tablets in a Hybrid Decentralized Clinical Trial Setting
This study is investigating a new tablet medication called etrasimod. Researchers want to understand how it affects the body when used for certain inflammatory conditions such as ulcerative colitis (a bowel condition), alopecia areata (hair loss), atopic dermatitis (eczema), and eosinophilic esophagitis (a problem with the food pipe). This is a very early stage study, often called Phase 1, which means it's one of the first times this medicine is being given to people to see how it works and if it's safe. It's designed to be a 'hybrid' study, meaning some parts might happen at a clinic and some can be done from your home using technology.
At a glance
What is this study about?
This study is about a new medicine called etrasimod, which comes in tablet form. Researchers are trying to understand exactly how this medicine acts inside the body. They are particularly interested in its effects on a group of conditions known as immune-mediated inflammatory disorders.
These conditions happen when your immune system, which normally fights off infections, mistakenly attacks healthy parts of your body, causing inflammation. The specific conditions being looked at in this study include ulcerative colitis, which affects the large bowel; alopecia areata, which causes hair loss; atopic dermatitis, a type of eczema; and eosinophilic esophagitis, which impacts the food pipe. By studying how etrasimod works, scientists hope to learn more about its potential to help people living with these conditions.
This is a very early stage (Phase 1) study for humans. This means it's among the first times the medication is being tested in people. The main goals at this stage are usually to check how the drug is absorbed, distributed, processed, and removed by the body, and to find out if it's safe and well-tolerated. The study is also designed to be a 'hybrid' trial, which means it might combine clinic visits with some activities that can be done remotely from your home, making participation potentially more flexible for some people.
Key takeaways
- This study is testing a new medicine called etrasimod in tablet form.
- It's for inflammatory conditions like ulcerative colitis, alopecia areata, eczema, and eosinophilic esophagitis.
- This is an early stage (Phase 1) study, focusing on how the drug works and its safety.
- It's designed to be partly done from home, making it a 'hybrid' study.
- Participants must be 18 years or older, both men and women can join.
- You'll be closely monitored by a medical team.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women can take part.
The specific details of who can and cannot join the study will be much more detailed than this. For example, there might be requirements about your overall health, any other medications you are taking, or if you have specific types of the conditions mentioned.
It's very important to discuss your full medical history with the study team. They will carefully check if this study is right for you, based on strict guidelines, to ensure your safety and that the study gets accurate results. Having one of the listed conditions alone doesn't guarantee you can take part.
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 18 years old or older?
- Do you have one of the listed inflammatory conditions (e.g., ulcerative colitis, alopecia areata, atopic dermatitis, eosinophilic esophagitis)?
- Are you comfortable with the idea of taking a new, experimental medicine?
- Are you able to attend clinic visits and potentially use technology for remote check-ups?
- Are you willing to share your full medical history with the study team?
What does participation involve?
If you decide to take part in this study, you would be taking the study medication, etrasimod, in tablet form. As this is a Phase 1 study, it typically involves several visits to a clinic, especially at the beginning, to carefully monitor how your body reacts to the new medicine. These visits might include blood tests, physical examinations, and other checks to see how the drug is working and to ensure you are safe.
Because it's a 'hybrid' study, some of your check-ups or data collection might happen remotely from your home, perhaps using technology like video calls or wearable devices, reducing the need for all appointments to be in person. The exact number of visits, tests, and the total length of time you'd be involved would be explained in detail by the study team. Your participation would likely last for a specific period of weeks or months, with follow-up appointments after you stop taking the drug.
Potential risks and benefits
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Common questions
What is etrasimod?
Etrasimod is a new tablet medicine being studied to see how it works in the body for certain inflammatory conditions.
Which conditions is this study about?
This study is looking at conditions like ulcerative colitis, alopecia areata, eczema (atopic dermatitis), and eosinophilic esophagitis.
Is this medicine available to the public?
No, etrasimod is currently an investigational medicine, meaning it's still being studied and is not yet available for general use.
What does 'hybrid' study mean?
A 'hybrid' study means some parts can be done at a clinic, and other parts might be done remotely from your home, using technology.
What is a Phase 1 study?
A Phase 1 study is a very early stage of human testing for a new medicine, mainly focused on understanding how it works in the body and if it's safe.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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