A Phase 2, multinational, multicenter, randomized, double blind, placebo controlled, dose-ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn’s disease.
Crohn's disease is a lifelong condition causing swelling and irritation in the digestive system. This Phase 2 study is testing an experimental drug named balinatunfib (SAR441566) in adults with moderate to severe Crohn's disease. Researchers want to find out how safe the medicine is, how well it works, and which dose is most effective. They will check if the drug helps calm bowel inflammation, heals the gut lining, and eases everyday symptoms like tummy pain and diarrhoea. Because this is a dummy-controlled study, some participants will receive the active medicine while others receive an inactive dummy pill (placebo). A computer decides who gets which treatment by chance. Taking part involves regular clinic appointments, health surveys, and gut checks. The findings could help doctors discover a helpful new treatment option for people living with Crohn's disease.
At a glance
What is this study about?
Crohn's disease causes parts of the gut to become inflamed, swollen, and sore. For many people, this leads to painful cramps, severe diarrhoea, tiredness, and weight loss. While existing medicines can help, they do not work for everyone, and their effects can fade over time. Researchers are therefore working to develop new treatments that target the inflammation in different ways.
This clinical trial is testing a new study drug called balinatunfib (also known as SAR441566). The main goal is to find out if this medicine can calm inflammation and heal the lining of the bowel in people with moderate to severe Crohn's disease. Doctors will use camera tests (endoscopies) to look directly at the gut lining and see if sores and swelling have improved.
Doctors also want to know how the drug affects everyday life. They will look at whether it relieves gut symptoms, improves general wellbeing, and causes any side effects. By testing a few different doses against a dummy treatment (placebo), the team hopes to find the safest and most effective dose for future care.
Key takeaways
- Tests a new medicine (balinatunfib) for moderate to severe Crohn's disease.
- Aimed at adults aged 18 and over.
- Compares different doses of the drug against an inactive dummy treatment (placebo).
- Checks gut healing using endoscopies and tracks your daily symptoms.
- Taking part is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to men and women aged 18 and older who have been diagnosed with moderate to severe Crohn's disease. It is mainly for people whose current medicines are not working well enough, or who cannot take certain standard treatments.
Because this is a clinical trial, there are strict health rules to protect your safety. You may not be able to take part if you have certain other serious medical conditions, active infections, or if you are pregnant or breastfeeding.
The study team will review your complete medical history, carry out health checks, and discuss your past treatments to confirm whether this trial is a safe and suitable match for you.
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.
- I am aged 18 or older.
- I have been diagnosed with moderate to severe Crohn's disease.
- My current Crohn's treatment is not controlling my symptoms well.
- I am willing to attend regular hospital appointments and have camera tests (endoscopies).
- I am not currently pregnant or planning a pregnancy during the trial.
What does participation involve?
If you take part, you will be placed into a group by chance—like flipping a coin. You will either receive the trial drug at one of several doses or a placebo, which looks identical but contains no active medicine. Neither you nor your study doctor will know which one you are taking during the initial part of the study, though you may have access to the real medicine later in an 'open-label' period.
Taking part involves regular visits to a hospital clinic. During these visits, doctors will check your general health, take blood and urine samples, and ask you to fill in questionnaires about your bowel habits, pain, and quality of life.
You will also have camera tests of your bowel (endoscopies) so doctors can look closely at your gut lining. The study lasts several months to monitor how your body responds to the treatment over time.
Potential risks and benefits
Locations (11)
- —UnverifiedHungary
- —UnverifiedSpain
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedCzechia
- —UnverifiedCroatia
- —UnverifiedPoland
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedItaly
- —UnverifiedNetherlands
Common questions
What is a placebo and why is it used?
A placebo is a dummy treatment that looks just like the real medicine but has no active ingredients. Comparing the study drug to a placebo helps scientists prove whether any health improvements are truly caused by the new medicine.
Can I choose which dose of the medicine I take?
No. A computer assigns you to a specific dose or the placebo completely at random. This makes the results fair and scientifically reliable.
Will taking part cost me anything?
No, the study medicine and all study-related tests are provided free of charge. Most trials also help cover reasonable travel expenses to and from the clinic.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can withdraw at any point without giving a reason, and your normal healthcare will not be affected.
What happens if my Crohn's disease gets worse during the trial?
Your safety comes first. The study doctors will monitor you closely. If your condition gets worse, they can change your treatment or remove you from the trial to ensure you receive the care you need.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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