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 ulcerative colitis
Ulcerative colitis is a long-term condition that causes painful inflammation and ulcers in the bowel lining, leading to symptoms like tummy pain, urgent diarrhoea, and bleeding. This Phase 2 clinical trial is testing a new medicine called SAR441566 (balinatunfib) in adults with moderate-to-severe ulcerative colitis. The main goal is to find out if the study medicine can heal the gut lining and bring symptoms into remission after 12 weeks. The trial is testing several different doses to discover the safest and most effective amount to take. Because this is a randomised, double-blind trial, some participants will receive the active study drug while others receive a dummy pill (placebo), and neither the patients nor the doctors will know who has which. The results will help researchers understand if SAR441566 could become an effective new treatment option in the future.
At a glance
What is this study about?
Ulcerative colitis is a long-lasting condition where the lining of the large bowel becomes inflamed and swollen. For many people, this causes frequent, urgent trips to the toilet, bloody stools, abdominal cramps, and deep fatigue. Although there are medications available today, they do not work for everyone, and some treatments can lose their effectiveness over time. Because of this, researchers are constantly working to develop new and better therapies.
This clinical trial is testing an experimental medicine known as SAR441566. It is designed to target specific parts of the immune system that cause inflammation in the gut. The main aim of the trial is to see whether SAR441566 can calm this inflammation, soothe bowel symptoms, and encourage the gut lining to heal—a state known as 'clinical remission'.
Because this is a Phase 2 trial, doctors are also trying to find the best dose of the medicine. They want to identify the amount that gives patients the greatest relief from their symptoms with the fewest side effects. Researchers will closely monitor participants using symptom questionnaires, blood tests, and camera examinations of the bowel to see how well the medicine works compared to a placebo.
Key takeaways
- Tests a new medicine (SAR441566) for moderate-to-severe ulcerative colitis.
- Aims to reduce gut inflammation and bring symptoms into remission by Week 12.
- Compares different doses of the medicine against a dummy treatment (placebo).
- Open to adults aged 18 and older.
- Involves clinic appointments, blood tests, questionnaires, and bowel camera checks.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with moderate-to-severe ulcerative colitis. It is open to all sexes whose bowel condition is currently active and causing ongoing symptoms.
In general, this study is meant for people whose colitis has not improved enough on standard medications, or who have had difficult side effects from other treatments.
You may not be able to join if you have other serious health problems, such as severe heart, liver, or kidney disease, an active severe infection, or a different bowel condition such as Crohn's disease. The study doctors will carefully review your medical history and carry out health checks to make sure taking part is safe 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 18 years of age or older.
- I have been diagnosed with ulcerative colitis.
- My colitis symptoms are currently moderate to severe.
- My current treatments are not controlling my symptoms well enough.
- I am willing to attend regular hospital check-ups and have bowel examinations.
What does participation involve?
If you decide to take part, you will first attend a screening visit where doctors will check your general health and run tests to confirm the trial is suitable for you. During the main 12-week study period, you will take your assigned study medication or a placebo as directed. You will need to visit the hospital clinic regularly for health checks, which include blood and stool tests, completing symptom diaries, and having an endoscopy (a gentle camera test that looks at the inside of your bowel) to see how well your gut is healing. After the first 12 weeks, you may be eligible to enter an extension period to receive ongoing treatment and monitoring. The study team will guide you through every step of the process.
Potential risks and benefits
Locations (12)
- —UnverifiedCroatia
- —UnverifiedRomania
- —UnverifiedGreece
- —UnverifiedItaly
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedHungary
- —UnverifiedCzechia
- —UnverifiedPoland
- —UnverifiedFrance
- —UnverifiedBulgaria
- —UnverifiedAustria
Common questions
What is a placebo and why is it used?
A placebo looks just like the real medicine but contains no active ingredients. It helps researchers prove whether any health improvements or side effects are truly caused by the study drug.
Will I definitely receive the new medicine?
Not necessarily. A computer randomly chooses whether you receive a dose of the study drug or the dummy treatment (placebo). Neither you nor your doctor can choose which one you receive.
Do I have to pay to take part in this study?
No. All study-related appointments, tests, and medications are provided free of charge, and trial teams often help cover reasonable travel expenses.
What happens if my symptoms get worse during the trial?
Your safety is always the highest priority. If your symptoms worsen or you have a flare-up, the medical team can provide standard rescue medications or withdraw you from the study if needed.
Can I leave the study if I change my mind?
Yes. Taking part is completely voluntary. You can choose to leave the trial at any point, for any reason, and your normal healthcare will continue as usual.
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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