A Study of Icotrokinra in Participants With Moderately to Severely Active Crohn's Disease
This research study is looking at an investigational medicine called icotrokinra for adults in the UK who have moderately to severely active Crohn's disease. Crohn's disease is a long-term condition that causes severe inflammation in the gut. The main aim is to understand how well icotrokinra works to improve symptoms and overall well-being, and to check for any side effects, comparing it against a placebo (a dummy medicine with no active ingredients). This study involves a detailed look at participants' current Crohn's activity and their past treatments to ensure it's the right fit for them.
At a glance
What is this study about?
You're invited to read about a research study for adults with Crohn's disease. Crohn's is a condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and tiredness. Even though there are treatments available, they don't work for everyone, or sometimes their effects don't last. This study is exploring a new investigational medicine called icotrokinra to see if it could be a helpful option.
The main goal of this study is to find out two key things: firstly, how effective icotrokinra is at helping to reduce the symptoms of moderately to severely active Crohn's disease, and secondly, to thoroughly check its safety. To do this, some participants will receive icotrokinra, while others will receive a placebo, which looks just like the study medicine but doesn't contain any active ingredients. This comparison helps researchers understand the true effects of icotrokinra.
This study is in 'Phase 2' and 'Phase 3'. This means that the medicine has already been through some initial safety tests, and now researchers are looking more closely at how well it works and its safety in a larger group of people. If the results are positive, it could mean a new treatment option for people living with Crohn's disease in the future.
Key takeaways
- This study investigates a new medicine, icotrokinra, for adults with Crohn's disease.
- It aims to understand how well icotrokinra works and if it's safe.
- Participants will receive either icotrokinra or a placebo (dummy medicine).
- Eligibility includes having moderately to severely active Crohn's and previous treatment experiences.
- Regular health check-ups and monitoring are part of the study participation.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
To join this study, doctors will first need to confirm you have Crohn's disease that has been active for at least 12 weeks. Your Crohn's should be considered 'moderately to severely active' based on symptom scores and pictures taken during an endoscopy. You will also need to have tried conventional treatments that haven't worked well enough, or you couldn't tolerate them. Some participants might have also tried more advanced treatments (like biologics) that didn't help enough.
There are also some reasons why you might not be able to join. For example, if you have complications from Crohn's that might need surgery soon, such as severe narrowing of your bowel, or if you've had major bowel surgery recently. If you have a stoma or ostomy, you also wouldn't be able to participate. However, if you have fistulas (abnormal connections) but don't need surgery for them, you might still be eligible.
If you are a woman who could become pregnant, you'll need to have negative pregnancy tests and agree to further tests during the study. The study is open to both men and women, aged 18 and over.
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 an adult aged 18 or older?
- Have you had a confirmed diagnosis of Crohn's disease for at least 3 months?
- Is your Crohn's currently moderately to severely active?
- Have conventional Crohn's treatments not worked well enough for you, or did you have trouble tolerating them?
- Do you not have complications of Crohn's that might need surgery soon (e.g., severe bowel narrowing)?
- Are you able to attend regular clinic visits and assessments?
What does participation involve?
If you decide to take part, you'll undergo several assessments to confirm your eligibility, including a review of your Crohn's diagnosis, symptom checks, and an endoscopy. You will receive either the investigational medicine, icotrokinra, or a placebo. Neither you nor your study doctor will know which treatment you are receiving until after the study is complete, unless there's a medical need to find out.
Your participation will involve regular visits to the study clinic for check-ups, assessments of your Crohn's symptoms, and to monitor your general health and any potential side effects. These visits will likely include blood tests, physical examinations, and questionnaires about your well-being. We don't have the exact duration of the study or frequency of visits in this summary, but these details would be fully explained by the study team, along with any necessary follow-up care after you stop taking the study medicine.
Potential risks and benefits
Locations (358)
- AZ Gastro CareVerified postcodeChandler, United States· Recruiting
- Mayo ClinicVerified postcodeScottsdale, United States· Recruiting
- Clinnova ResearchVerified postcodeAnaheim, United States· Recruiting
- Alliance Research Institute, LLC - Canoga ParkVerified postcodeCanoga Park, United States· Recruiting
- Southern California Research CenterVerified postcodeCoronado, United States· Recruiting
- Om Research, LLC 1Verified postcodeLancaster, United States· Recruiting
- TLC Clinical Research IncVerified postcodeLos Angeles, United States· Recruiting
- GastroIntestinal BioscienceVerified postcodeLos Angeles, United States· Recruiting
- Om Research, LLC 2Verified postcodeOxnard, United States· Recruiting
- Clinical Applications Laboratories, IncVerified postcodeSan Diego, United States· Recruiting
- Medical Associates Research Group, Inc.Verified postcodeSan Diego, United States· Recruiting
- University of California San FranciscoVerified postcodeSan Francisco, United States· Recruiting
Common questions
What is Crohn's disease?
Crohn's disease is a long-term condition that causes inflammation in your digestive system, which can lead to symptoms like stomach pain, diarrhoea, and tiredness.
What is icotrokinra?
Icotrokinra is an investigational medicine being tested in this study to see if it can help people with moderately to severely active Crohn's disease.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the study medicine but contains no active ingredients. It helps researchers compare the true effects of the investigational medicine.
Will I know if I'm getting the study medicine or the placebo?
In this type of study, neither you nor your study doctor will know whether you are receiving the active medicine or the placebo until after the study is finished.
Can I leave the study at any time?
Yes, you are free to withdraw from the study at any point, for any reason, and this will not affect your ongoing medical care.
How to find out more
Study Contact
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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