A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
This study is called a Phase 2 trial and is looking at how well a new drug, SAR442970, works safely in adults with moderate to severe Ulcerative Colitis. Some participants will receive the active drug, and others will receive a dummy pill (placebo). The researchers want to find the best dose to help manage your condition. If you respond well to the initial treatment, you might have the option to continue receiving the study drug for a longer time, up to 104 weeks. The entire study could last nearly three years.
At a glance
What is this study about?
This research study is focused on a health condition called Ulcerative Colitis (UC). UC is a long-term illness where the large bowel (colon) and rectum become inflamed. This can cause symptoms like tummy pain, diarrhoea, and blood in your poo. Doctors are always looking for new and better ways to treat UC, and this study is testing a new drug called SAR442970.
The main goal of this study is to see if SAR442970 can help people with moderate to severe UC feel better and if it's safe to use. Moderate to severe UC means that your symptoms are quite noticeable and are impacting your daily life. The study will compare different strengths (doses) of SAR442970 against a 'dummy' treatment (called a placebo) to understand its effects more clearly. Neither you nor your study doctor will know whether you are receiving the active drug or the placebo during the main part of the study; this is called 'double-blind'.
For those who find the treatment helpful and meet certain criteria, there's a chance to continue taking the study drug for a longer period, up to an extra 104 weeks. This extended period helps researchers understand the long-term effects and safety of the drug. The total time you could be involved in the study, if you qualify for the long-term extension, could be up to 168 weeks, which is about three and a quarter years.
Key takeaways
- This study is testing a new drug for moderate to severe Ulcerative Colitis.
- It compares two doses of the new drug, SAR442970, to a dummy pill (placebo).
- You will be closely monitored by a medical team throughout the study.
- Participation could last for over three years, with an option for long-term treatment if it helps.
- It's a way to potentially access a new treatment and contribute to medical research.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old diagnosed with Ulcerative Colitis for at least three months. Your UC symptoms must be active and classed as moderate to severe, which doctors check using specific scoring systems and by looking at your bowel.
You would also need to have tried some standard UC treatments before that either didn't work well enough, stopped working, or caused side effects. This might include common medications like aminosalicylates or steroids. Alternatively, if you've tried more advanced treatments, such as biologic drugs, and they haven't worked, you might also be suitable. It’s important that you don't have other bowel conditions like Crohn's Disease. If you're currently dealing with certain infections, you won't be able to join. Both men and women will need to use approved birth control methods during the study.
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.
- Are you between 18 and 75 years old?
- Do you have moderate to severe Ulcerative Colitis that has been active for at least 3 months?
- Have you tried other UC treatments that didn't work well or caused problems?
- Do you NOT have Crohn's Disease or certain infections?
- Are you willing to use appropriate birth control if required?
What does participation involve?
If you decide to take part, you'll be assigned to one of three groups by chance: one group will receive a specific dose of SAR442970, another group a different dose, and the third group will receive a placebo (dummy drug). Neither you nor your study doctor will know which you are receiving initially. You will have regular visits to the clinic for assessments, which will include examinations, blood tests, and possibly endoscopies (where a tiny camera looks inside your bowel). These visits help the study team monitor your health, check how you're responding to the treatment, and watch for any side effects.
The initial treatment period is for a set amount of time. If you meet certain conditions and are benefiting from the treatment, you might have the option to continue taking the study drug, knowing it is the active drug, in a long-term extension part of the study. This extension could last for up to 104 weeks. The total length of your participation, if you join the extension, could be up to 168 weeks (about 3 years and 3 months). Throughout this time, you will continue to have regular check-ups.
Potential risks and benefits
Locations (67)
- Investigational Site Number: 8400009Verified postcodeEscondido, United States· Recruiting
- Investigational Site Number: 8400006Verified postcodeLancaster, United States· Recruiting
- Investigational Site Number: 8400025Verified postcodeThousand Oaks, United States· Recruiting
- Investigational Site Number: 8400024Verified postcodeJacksonville, United States· Recruiting
- Investigational Site Number: 8400030Verified postcodeKissimmee, United States· Recruiting
- Investigational Site Number: 8400003Verified postcodeLighthouse PT, United States· Recruiting
- Investigational Site Number: 8400001Verified postcodeMiami, United States· Recruiting
- Investigational Site Number: 8400011Verified postcodeMiami, United States· Recruiting
- Investigational Site Number: 8400010Verified postcodePalmetto Bay, United States· Recruiting
- Investigational Site Number: 8400019Verified postcodeTampa, United States· Recruiting
- Investigational Site Number: 8400018Verified postcodeMarietta, United States· Recruiting
- Investigational Site Number: 8400005Verified postcodeIowa City, United States· Recruiting
Common questions
What is Ulcerative Colitis?
Ulcerative Colitis is a long-term disease where the lining of your large bowel (colon) and rectum becomes inflamed, causing symptoms like tummy pain, diarrhoea, and blood in your poo.
What is a 'Phase 2' study?
Phase 2 means this is an early stage of testing where doctors are looking to see if a new drug works, what the best dose might be, and if it's safe for people with the condition.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real drug but contains no active medicine. It helps researchers accurately compare if the new drug has a real effect.
How long will I be in the study if I join?
The study could last for an initial treatment period, and if you're eligible and respond well, there's an option to continue for a longer period, making your total time in the study up to about 3 years and 3 months.
Can I stop participating in the study at any time?
Yes, you are free to leave the study at any point, for any reason, and it will not affect your future medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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