KAN-101-03: A Phase 2a Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of KAN-101 In Participants With Celiac Disease
This study, called KAN-101-03, is looking into a new medicine called KAN-101 for people who have coeliac disease. It's a Phase 2a trial, which means it's an early stage study designed to understand if the medicine works to improve the gut lining, how safe it is, and how well people can tolerate it. Some participants will receive KAN-101, while others will get a placebo (a dummy treatment, like salt water) without knowing which they have. Researchers will take measurements, including small samples of the gut lining, to see if the medicine helps the gut heal and reduce inflammation. The study also checks for any side effects and how the body handles the medicine. It's for adults aged 18 and over, of any sex.
At a glance
What is this study about?
This research study is about a new medicine called KAN-101 for people living with coeliac disease. Coeliac disease is a condition where eating gluten, found in foods like wheat, barley, and rye, damages the lining of your small intestine. This damage can make it hard for your body to absorb nutrients and can cause symptoms like tummy pain, bloating, and tiredness.
The main goal of this study is to see if KAN-101 can help to heal the damage in the small intestine caused by coeliac disease. Researchers are particularly interested in looking at how the small intestine's villi – the tiny, finger-like structures that absorb nutrients – respond to the treatment. They also want to understand if the medicine is safe to use and if people can take it without too many problems.
To do this, some participants will receive the active medicine (KAN-101) and others will receive a placebo, which looks exactly like the medicine but contains no active ingredients. This is a common way to test new medicines fairly. By comparing the results from both groups, the researchers can work out if KAN-101 is genuinely effective and safe. The study also looks at other changes in the gut and monitors for any side effects.
Key takeaways
- This study is testing a new medicine (KAN-101) for coeliac disease.
- It aims to see if the medicine helps heal the gut and if it's safe.
- You might receive the new medicine or a dummy treatment (placebo).
- It involves regular clinic visits, blood tests, and an endoscopy with biopsies.
- The study is for adults aged 18 and over, regardless of sex.
Who may be eligible?
To take part in this study, you must be at least 18 years old. There is no upper age limit, meaning older adults can also participate if they meet other health requirements.
Both men and women are welcome to join this study. The researchers want to include a wide range of people to understand how the medicine works across different individuals.
Specific medical details will be checked by the study team to make sure it's safe for you to take part and that the study results will be meaningful. For example, they'll need to confirm you have coeliac disease and may ask about other health conditions or medicines you are currently taking.
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?
- Have you been diagnosed with coeliac disease?
- Are you able to attend appointments at the study clinic?
- Are you comfortable with having an endoscopy with biopsies?
- Are you willing to potentially receive a placebo?
- Do you understand that you will need to continue your gluten-free diet during the study?
What does participation involve?
If you decide to take part, you will be in the study for a certain period. During this time, you will receive either the new medicine, KAN-101, or a placebo (a dummy treatment made of salt water). This will be given as a drip into your arm (intravenous infusion). You won't know whether you are receiving the real medicine or the placebo.
You'll have several visits to the clinic. These visits will involve various checks and assessments, such as blood tests, physical examinations, and possibly questionnaires about how you are feeling. A key part of the study involves an endoscopy, which is a procedure where a thin, flexible tube with a camera is passed down your throat to look at your small intestine. During this, small tissue samples (biopsies) will be taken. This happens at the beginning of the study and again after two weeks of receiving the treatment to see if there have been any changes in your gut lining. The total duration of your active participation, including follow-up, will be explained fully by the study team.
Potential risks and benefits
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Common questions
What is KAN-101?
KAN-101 is a new medicine being tested to see if it can help heal the gut lining in people with coeliac disease.
What is a placebo?
A placebo is a 'dummy' treatment that looks just like the real medicine but contains no active ingredients. It's used for comparison.
Will I know if I'm getting the medicine or the placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until after the study is over.
What is an endoscopy and why is it needed?
An endoscopy is a procedure to look inside your small intestine and take tiny tissue samples (biopsies). It's needed to check for changes in your gut lining caused by coeliac disease and to see if the medicine is helping it heal.
Can I stop participating in the study if I want to?
Yes, you can choose to leave the study at any point, for any reason, and it won't affect your ongoing medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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