RecruitingPHASE2INTERVENTIONAL

A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

This study aims to find out if a new medication, SAR442970, is effective and safe for adults aged 18 to 75 with moderate to severe Crohn's disease. Some participants will receive the new medicine, while others will receive a placebo (a dummy pill with no active drug) to compare results. This type of study is called 'double-blind' because neither the patients nor the doctors will know who is getting which treatment, which helps make the results fair and unbiased. The study will last a long time, potentially over three years, including an option for participants to continue receiving the study drug if it works well for them. This will help doctors understand its long-term effects.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Sanofi

Enrolment target

Start

03 Jun 2025

Estimated completion

17 Oct 2029

Crohn's Disease

What is this study about?

Crohn's disease is a long-term condition where parts of the digestive system become inflamed. This can cause various symptoms like tummy pain, diarrhoea, weight loss, and extreme tiredness. Existing treatments help many people, but they don't work for everyone, or their effects might wear off over time. That's why researchers are always looking for new and better ways to manage the condition. This study is testing a new medication called SAR442970.

The main goal of this particular study is to see how well SAR442970 works compared to a 'placebo' (a dummy pill that looks like the medicine but contains no active drug). Researchers will also be carefully checking for any side effects to make sure the medicine is safe. By comparing SAR442970 to a placebo, doctors can get a clear picture of whether the new medicine is actually making a difference for people with moderate to severe Crohn's disease.

This is a 'Phase 2' study, which means the new medicine has already gone through initial safety tests, and now researchers are looking at the right dose and how effective it is in a larger group of patients. The study is also designed to be 'randomized' and 'double-blind'. Randomised means participants are put into groups by chance, like flipping a coin, to ensure fairness. Double-blind means neither you nor your study doctor will know if you're receiving SAR442970 or the placebo. This helps prevent any bias in how effects are judged.

Key takeaways

This study is testing a new medicine called SAR442970 for moderate to severe Crohn's disease.
It's a 'Phase 2' study, focusing on how well the medicine works and its safety.
Participants will be randomly assigned to receive either the new medicine or a dummy pill (placebo).
Neither you nor your doctor will know which treatment you are receiving (this is called 'double-blind').
The study could last for over three years, including an optional long-term treatment period.
You must have tried other Crohn's treatments that haven't worked well enough for you.

Who may be eligible?

To join this study, you must be between 18 and 75 years old and have been diagnosed with Crohn's disease for at least three months. Your Crohn's disease needs to be classed as 'moderate to severe', and you should have already tried some standard treatments (like certain tablets or injections) but found they didn't work well enough, stopped working, or caused problems you couldn't tolerate. If you're currently on other treatments for Crohn's, your dose needs to be stable before you can join.

Quick self-check

Are you between 18 and 75 years old?
Have you been diagnosed with Crohn's disease for at least 3 months?
Is your Crohn's disease currently considered moderate to severe?
Have you tried other Crohn's treatments that didn't work well or you couldn't tolerate?
Do you use reliable contraception if it applies to you?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be assigned by chance to either receive the new medicine, SAR442970, or a dummy pill (placebo). You won't know which you are receiving, and neither will your study doctor. You'll have regular visits to the clinic for check-ups, blood tests, and other assessments to monitor your health and how the treatment is affecting your Crohn's. The initial treatment period is up to 158 weeks, which is about three years. If the study medicine is helping you and you meet certain criteria, you might be able to continue taking it for an additional period of up to 104 weeks (about two more years) as part of an 'open-label' extension. 'Open-label' means both you and your doctor would know you are receiving SAR442970. The total time you could be involved in the study could be up to 168 weeks, or just over three years.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to a new treatment before it's widely available and contributing to medical knowledge that could help others. However, there are also potential risks; for instance, the new medicine may not work for you, or you might experience side effects. The placebo group won't receive active medication during the initial phase. All potential risks and side effects will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (66)

Investigational Site Number: 8400024
Tucson, United States· Recruiting
Investigational Site Number: 8400005
Escondido, United States· Recruiting
Investigational Site Number: 8400001
Lancaster, United States· Recruiting
Investigational Site Number: 8400017
Kissimmee, United States· Recruiting
Investigational Site Number: 8400015
Lighthouse PT, United States· Recruiting
Investigational Site Number 8400028
Miami, United States· Recruiting
Investigational Site Number: 8400012
Miami, United States· Recruiting
Investigational Site Number: 8400007
Orlando, United States· Recruiting
Investigational Site Number: 8400011
Palmetto Bay, United States· Recruiting
Investigational Site Number: 8400019
Marietta, United States· Recruiting
Investigational Site Number: 8400025
Iowa City, United States· Recruiting
Investigational Site Number: 8400006
Kansas City, United States· Recruiting

+54 more sites — see the official record for the full list.

Common questions

What is a 'placebo'?

A placebo is a dummy pill that looks exactly like the study medicine but doesn't have any active drug in it. It helps researchers compare the real medicine's effects fairly.

What does 'double-blind' mean?

It means that neither you nor your study doctor will know whether you are receiving the new medicine or the placebo. This helps make the study results as accurate and unbiased as possible.

How long would I be in the study?

The study could last for up to 168 weeks, which is a bit over three years. This includes an option to continue with the study medicine if it helps you.

Can I continue my other Crohn's medications?

You might be able to continue some of your usual Crohn's medications, but they would need to be at a stable dose before you start the study. The study team will advise you on this.

Is this study suitable for all types of Crohn's disease?

This study is specifically for people with moderate to severe Crohn's disease that affects certain parts of the bowel, but not those with complications requiring surgery, or specific forms like Ulcerative Colitis.

How to find out more

Trial Transparency email recommended (Toll free for US & Canada)

contact-us@sanofi.com 800-633-1610 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.