Study Comparing Intravenous (IV)/Subcutaneous (SC) Risankizumab to IV/SC Ustekinumab to Assess Change in Crohn's Disease Activity Index (CDAI) in Adult Participants With Moderate to Severe Crohn's Disease (CD)
This study is looking into two treatments, risankizumab and ustekinumab, for adults who have moderate to severe Crohn's disease. Crohn's is a long-term condition that causes inflammation in the gut. Ustekinumab is an approved treatment, and risankizumab is a new treatment being tested. The aim is to see how well risankizumab works compared to ustekinumab in reducing symptoms. Participants will be randomly put into one of three groups, each receiving a different treatment plan. Roughly 508 adults will take part across many locations worldwide. Treatment starts with medicine given into a vein (IV), followed by injections under the skin (SC). The study will track changes in your Crohn's Activity Index (CDAI) to see how well the treatments are working.
At a glance
What is this study about?
This research study is about finding the most effective ways to manage Crohn's disease, a chronic condition causing inflammation in the digestive system. We're specifically comparing two treatments: risankizumab and ustekinumab. Ustekinumab is a medication already approved and used for moderate to severe Crohn's, while risankizumab is a newer drug that scientists are investigating to see if it can also help.
The main goal of this study is to measure how well risankizumab works compared to ustekinumab in reducing the symptoms and activity of Crohn's disease. To do this, we'll monitor changes in what's called the Crohn's Disease Activity Index (CDAI), which helps doctors understand how active an individual's Crohn's disease is. Finding effective treatments is really important for improving the quality of life for people living with this condition.
About 508 adults with moderate to severe Crohn's disease will take part in this study, which is happening in many different places around the world. Participants will be randomly assigned to receive one of the study treatments. This means there's an equal chance you could receive either risankizumab or ustekinumab, or a different treatment plan combining these. This careful approach helps us fairly compare how well each treatment works.
Key takeaways
- Compares two treatments for moderate to severe Crohn's disease.
- Risankizumab is a new drug, Ustekinumab is an approved one.
- Around 508 adults will participate worldwide.
- Treatment starts with IV, then switches to injections under the skin.
- You'll have regular visits for checks, blood tests, and questionnaires.
- You can leave the study at any time.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 80 years old, with a confirmed diagnosis of Crohn's disease for at least three months. Your Crohn's disease must be classified as moderate to severe and currently active, based on specific medical assessments.
Crucially, you should have tried at least one type of anti-TNF treatment for your Crohn's in the past but either couldn't tolerate it due to side effects or found that it didn't help enough with your symptoms.
There are also some reasons why you might not be able to join. For example, if you have a different bowel condition like ulcerative colitis, or if you've already received certain types of biological medicines or experimental treatments that are similar to the ones being tested in this study. Also, if you have current severe complications from your Crohn's, like blockages in your bowel or a very short bowel, you might not be eligible.
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 80 years old?
- Have you been diagnosed with Crohn's disease for at least 3 months?
- Is your Crohn's currently moderate to severe?
- Have you tried an anti-TNF treatment for your Crohn's in the past and it didn't work well or you couldn't tolerate it?
- Do you currently have any severe Crohn's complications like blockages or a very short bowel?
- Have you used similar biological or experimental treatments before?
What does participation involve?
If you join this study, you will be randomly assigned to one of three treatment groups. This means you have a 1 in 2 chance of receiving ustekinumab. In the first phase of the study, lasting 48 weeks, you will initially receive your treatment through an intravenous (IV) drip in your arm at weeks 0, 4, and 8, or just at week 0 depending on your group. After this, you will receive injections under the skin (subcutaneous, or SC) every 8 weeks, also for 48 weeks.
If you receive risankizumab in the first part and complete the 48-week visit, you might continue receiving the SC risankizumab injections for up to an additional 220 weeks, which is about four more years. During your time in the study, you will need to attend regular hospital or clinic visits. At these visits, the study team will conduct medical checks, take blood samples, ask about any side effects you might be experiencing, and have you complete questionnaires to understand how you are feeling and how the treatment is affecting your Crohn's. The total duration of participation could be several years.
Potential risks and benefits
Locations (300)
- Advanced Gastroenterology, P.C /ID# 224396Verified postcodeChandler, United States
- Southern California Res. Ctr. /ID# 223484Verified postcodeCoronado, United States
- Hoag Memorial Hosp Presbyterian /ID# 224373Verified postcodeIrvine, United States
- United Medical Doctors /ID# 223486Verified postcodeLos Alamitos, United States
- TLC Clinical Research Inc /ID# 223467Verified postcodeLos Angeles, United States
- Duplicate_UC Davis Medical Center /ID# 225700Verified postcodeSacramento, United States
- Duplicate_University of California, San Francisco /ID# 223621Verified postcodeSan Francisco, United States
- Duplicate_Western Connecticut Medical Group /ID# 223478Verified postcodeDanbury, United States
- Duplicate_Medical Research Center of CT /ID# 223540Verified postcodeHamden, United States
- Yale Univ Digestive Diseases /ID# 224463Verified postcodeNew Haven, United States
- Omega Research Maitland, LLC /ID# 223463Verified postcodeDeBary, United States
- Nature Coast Clinical Research - Inverness /ID# 223600Verified postcodeInverness, United States
Common questions
What is Crohn's Disease?
Crohn's Disease is a long-term condition where parts of your digestive system become inflamed. This can cause symptoms like tummy pain, diarrhoea, tiredness, and weight loss.
What does 'randomly assigned' mean?
It means a computer will decide which treatment group you are in, like flipping a coin. Neither you nor the doctors can choose your group, which helps make the study fair.
What is the difference between IV and SC treatment?
IV means the medicine is given into a vein, usually in your arm, through a drip. SC means the medicine is given as an injection just under your skin, often in your tummy or thigh.
Will I know if I'm getting the new drug or the approved one?
In some studies, you might not know, but here, participants are assigned to different known treatments. Your doctor will explain which treatment you are receiving if you join.
What is the Crohn's Disease Activity Index (CDAI)?
The CDAI is a way doctors measure how active your Crohn's disease is, based on your symptoms and some medical tests. A lower score usually means your Crohn's is less active.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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