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.
Published: 02/12/2026
General Information:
The study aims to evaluate if the Investigational study drug (given as pills) can improve signs and symptoms of moderate to severe Crohn’s disease (CD), as well as to see if it has any side effects.
Eligibility:
Inclusion:
- Aged between 18 and 75 years
- Confirmed diagnosis of Crohn’s Disease for at least 3 months prior to Baseline
- Have currently active, moderate to severe Crohn’s Disease
- Participants either are not able to take, did not benefit from, or no longer benefit from at least 1 of the following approved treatments: amino-salicylate, corticosteroids, immunosuppressants, antibiotics, or advanced therapies like biologics or small molecules
- Standard treatment allowed as background therapies if on stable dose prior to screening
- Both sexually-active men and women (of child-bearing potential) will be required to use contraceptives during the study. Female participants should not be pregnant or breastfeeding (these are standard precautions taken during clinical studies to avoid any potential unknown risks to a baby or fetus from a medicine that is still being studied).
Exclusion:
- Persons with active Ulcerative Colitis, indeterminate colitis or short bowel syndrome
- Persons with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
- Persons with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of > 3 bowel resections
Other protocol-defined exclusion criteria apply and will be provided during eligibility screening, which may include other serious illnesses that could affect the participant’s ability to safely participate in research.
Study Details:
Study description/explanation of participation:
Before you join the study, there will be a 4 to 5-week screening period to determine if this study is right for you. During this time, you will have regular medical check-ups, similar to what you would have at your doctor's office. These include blood tests, colonoscopies and some questionnaires about your health.
If you qualify and choose to take part, the study will last about one year. You will be given either the investigational study drug or a placebo (a look-alike with no active medicine), but you won't know which one you are receiving. To help us understand how you are feeling, we will ask you to fill out a brief daily diary about your Crohn's symptoms.
If your symptoms do not improve or get worse after the first 12 weeks, you may be eligible to switch to the actual investigational study drug.
You'll need to visit the clinic about once a month (12-14 times total) during the year. After the treatment ends, we'll check in with you one final time two weeks later.
Description of treatment or intervention (mechanism of action):
The Investigational study drug is a new experimental drug that inhibits Tumor necrosis factor receptor 1 (TNFR1) signaling. In people with Crohn’s Disease, TNFR1 signaling is over-active causing inflammation, which results in Crohn’s Disease symptoms. The investigational study drug is designed to stop the activation of TNFR1, thereby stopping the chronic cycle of inflammation in CD, which may reduce the signs and symptoms of CD. This study is being done to test different amounts of the investigational study drug to find the dose that works the best.
The investigational study drug is a tablet that will be taken by mouth.
Patient Participation Requirements :
- Attend the scheduled visits (12-14 clinic visits in a year) and allow the tests or procedures to be performed as planned (3 colonoscopies in 1 year, tissue/blood/stool samples, ECG, etc…),
- Complete daily symptom tracking in an electronic diary
- Provide truthful information about your medical condition(s) and drug(s) that you have been taking for this (these) condition(s),
- Inform the study doctor before stopping or modifying your treatment(s) or before starting any new treatment(s).
Possible risks and side effects:
The purpose of clinical studies is to test new, experimental medicines to see how well they work and to learn about any potential side effects they may cause. There is always a possible risk for unknown side effects. So far (in earlier clinical studies), the investigational study drug has been generally well-tolerated with no serious side effects and no important identified risks.