Crohn’s disease attacks from multiple angles. We should too.
Crohn’s disease (CD) is a complex and debilitating disease that significantly affects people’s lives. It causes inflammation in the gastrointestinal tract, which can lead to fibrosis (an excessive build-up of scar tissue in the intestinal wall).
There are many approved treatments for CD. But unfortunately, they don’t always work for everyone. Which is why we’re conducting SIBERITE-1 and SIBERITE-2 – two clinical studies to see if an investigational medicine that targets not only inflammation, but also fibrosis, could improve the symptoms and quality of life of people living with CD.
Who can take part?
We’re looking for around 1,025 people to join who:
Are aged between 16 and 80*
Are diagnosed with moderate to severely active CD
Have tried at least one medicine for their CD that didn’t work, stopped working, or caused unacceptable unwanted effects
*Eligibility for people aged 16 and 17 depends on local guidelines and regulations.
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Please contact us if you're interested in taking part or if you'd like to learn more.
What will taking part involve?
If you choose to take part, your total time in the study will depend on whether you join SIBERITE-1 or SIBERITE-2.
SIBERITE-1
If you join SIBERITE-1, you’ll take part for up to around 1 year and 4 months (excluding the optional open-label extension). During this time, you’ll have at least 18 study visits.
SIBERITE-2
If you join SIBERITE-2, you’ll take part for up to around 7 months (excluding the optional open-label extension). During this time, you’ll have at least 8 study visits.
Screening period
Around 1 month
We’ll carry out some health assessments to see if you and the study are a good fit.
Screening period
Around 1 month
We’ll carry out some health assessments to see if you and the study are a good fit.
Double-blind treatment period
Around 1 year
If you’re eligible and decide to join, you’ll be randomly placed in one of two groups:
Group 1: You’ll be given the investigational medicine
Group 2: You’ll be given a placebo
You’ll be given the first four doses of your assigned study medicine as intravenous (IV) infusions. Your remaining doses will be given as subcutaneous (under the skin) injections.
Double-blind treatment period
Around 3 months
If you’re eligible and decide to join, you’ll be randomly placed in one of two groups:
Group 1: You’ll be given the investigational medicine
Group 2: You’ll be given a placebo
You’ll be given your assigned study medicine as intravenous (IV) infusions.
Optional open-label extension (OLE)
Once you’ve completed the treatment period, or if your symptoms have not improved after the first 2.5 months of receiving your assigned study medicine, you may be able to join the OLE. Everyone who joins the OLE will be given the investigational medicine as subcutaneous injections, even if they were previously given the placebo. The OLE phase will continue until the study ends.
Optional open-label extension (OLE)
Once you’ve completed the treatment period, you may be able to join the optional OLE. Everyone who joins the OLE will be given the investigational medicine as subcutaneous injections, even if they were previously given the placebo. The OLE phase will continue until the study ends.
Follow-up period
Around 3 months
You’ll have two follow-up visits so we can check how you’re feeling.
Follow-up period
Around 3 months
You’ll have two follow-up visits so we can check how you’re feeling.
What is a placebo?
A placebo looks just like the investigational medicine and is given in the same way. However, it contains no active medicine. Many clinical studies (like this one) are ‘placebo-controlled.’
How long will study visits last?
Each study visit may vary in length, but could range from 30 minutes to 5 hours.
What is meant by double-blind?
Double-blind means that neither you nor the study team will know which group you’re in until after the study is complete. This is to ensure that any differences seen are due to the investigational medicine alone.
What is the OLE phase of the study?
An open-label extension, or ‘OLE’, is an optional continuation of a clinical study. ‘Open-label’ means that both you and the study team will know that you’re being given the investigational medicine. OLEs are conducted so that researchers can continue to monitor the long-term effects of an investigational medicine.
How is the investigational medicine thought to work?
Our immune system relies on signals from proteins to protect us from bacteria, viruses, and parasites. One important protein is called TL1A.
TL1A can enhance the body’s existing response to inflammation.
It has been found that people with CD have increased levels and activity of TL1A.
This increase in TL1A is thought to cause inflammation and fibrosis, leading to the symptoms of CD.
So we’ve designed the investigational medicine to work by blocking TL1A, thereby reducing its levels and activity.
It’s hoped that this could potentially help improve the symptoms of people living with CD.
How will my health be monitored?
Your safety is our top priority. So, during SIBERITE-1 and SIBERITE-2, we’ll conduct regular health assessments and medical procedures to monitor your health. These will vary between visits and may include:
Blood samples
Physical examinations
Stool samples
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Please contact us to learn more or find out if you could take part.