Study of Targeted Therapies for the Treatment of Adult Participants With Moderate to Severe Crohn's Disease
Crohn's disease is a long-term condition that causes inflammation in the gut, leading to symptoms like belly pain and tiredness. Current treatments don't work for everyone or can stop working over time. This research study is testing new 'targeted therapies' – risankizumab, trosunilimab, lutikizumab, and ABBV-8736 – to see how effective and safe they are for adults with moderate to severe Crohn's disease. About 540 people will take part in this worldwide study. Participants will receive one of the study medicines, given either by injection under the skin or into a vein, and will have regular check-ups to monitor their health and the treatment's effects. The aim is to find better ways to help people living with Crohn's disease.
Överblick
Vad handlar denna studie om?
Crohn's disease is a condition that causes ongoing inflammation in your digestive system, most often in the bowel. This can lead to various uncomfortable symptoms such as tummy pain, diarrhoea, feeling very tired, and losing weight. While there are treatments available for Crohn's, they don't always work for everyone, or their effectiveness might lessen over time. This means doctors are always looking for new and better ways to help people manage their condition.
This study, called a Phase 2 trial, is exploring some newer types of medicines known as 'targeted therapies'. These medicines are designed to specifically block certain parts of the body's immune system that cause inflammation in Crohn's disease. The goal is to see how well these new treatments work in adults who have moderate to severe Crohn's, and to understand any potential side effects they might have.
The specific medicines being tested are risankizumab, trosunilimab, lutikizumab, and ABBV-8736. Participants will be fairly assigned to receive one of these medicines. These treatments are given either as an injection under the skin (like an insulin shot) or as a drip into a vein (like a blood transfusion). Researchers will carefully monitor participants' health throughout the study to learn more about these potential new options for treating Crohn's.
Viktiga punkter
- This study is for adults with moderate to severe Crohn's disease whose current treatments aren't fully effective.
- It's testing four new 'targeted therapy' medicines to see how well they work and if they're safe.
- Treatments are given either by injection under the skin or by drip into a vein.
- Participation involves more regular hospital/clinic visits, tests, and keeping a diary.
- You might get access to new treatments before they are widely available.
- You can stop participating in the study at any time if you wish.
Vem kan vara berättigad?
To be considered for this study, you must be an adult aged between 18 and 75 years old and weigh at least 6 stone 4 pounds (40 kg). You need to have a confirmed diagnosis of Crohn's disease for at least three months, with clear signs of inflammation in your bowel as seen during an endoscopy.
Crucially, your current Crohn's treatment must not be working well, or you must have had significant side effects from previous treatments. This study is for people whose Crohn's disease is considered moderate to severe, based on certain medical scores.
There are also some reasons why you wouldn't be able to join. For example, if you've already had bad reactions to similar types of medicine (specifically 'p19 inhibitors', which includes risankizumab), or if you've recently taken part in another trial for a similar new Crohn's medicine. You also can't participate if you have other conditions like ulcerative colitis, certain surgical complications from Crohn's (like an ostomy, a very short bowel, or recent bowel surgery within the last three months).
Kan denna studie passa dig?
Svara på dessa snabba frågor för att se om du kan vara berättigad. Detta är endast en vägledning — forskarteamet fattar det slutgiltiga beslutet.
- Are you an adult aged between 18 and 75?
- Do you have a confirmed diagnosis of Crohn's disease for at least three months?
- Is your current Crohn's treatment not working well enough, or have you had bad side effects from past treatments?
- Do you currently have signs of active inflammation in your bowel?
- Have you *not* had severe reactions to similar anti-inflammatory medicines in the past?
- Have you *not* had bowel surgery in the last three months, or do you *not* have an ostomy or very short bowel?
Vad innebär deltagande?
If you decide to take part, you'll be assigned to receive one of the study medicines – risankizumab, trosunilimab, lutikizumab, or ABBV-8736. Depending on the medicine, you'll either have regular injections under your skin that you might learn to do yourself, or you’ll need to come to the hospital or clinic for drips into your vein.
Throughout the study, you'll have more regular visits to the hospital or clinic than you might normally. These visits are important for the research team to closely monitor your health. You'll have medical check-ups, blood tests, and sometimes endoscopies (a procedure to look inside your bowel). The team will also ask you questions about how you're feeling, record any side effects, and you'll complete questionnaires and keep a daily diary to track your symptoms. The total duration of your involvement in the study will be explained to you by the research team.
Potentiella risker och fördelar
Platser (255)
- Digestive Health Specialists /ID# 266216Verifierat postnummerDothan, USA· Rekrytering
- East View Medical Research /ID# 270377Verifierat postnummerMobile, USA· Rekrytering
- Southern California Res. Ctr /ID# 265549Verifierat postnummerCoronado, United States· Rekrytering
- UC San Diego Health System /ID# 265565Verifierat postnummerLa Jolla, USA· Rekrytering
- uc davis medical center - patient support services building /ID# 265554Verifierat postnummerSacramento, USA· Rekrytering
- Clinical Applications Laboratories - San Diego - 3rd Avenue /ID# 267391Verifierat postnummerSan Diego, USA· Avslutad
- Peak Gastroenterology Associates - Colorado Springs - North Cascade Avenue /ID# 265557Verifierat postnummerColorado Springs, USA· Rekrytering
- Danbury Hospital, Western Connecticut Health Network /ID# 265556Verifierat postnummerDanbury, United States· Rekrytering
- Yale University School of Medicine /ID# 266786Verifierat postnummerNew Haven, USA· Rekrytering
- Novum Research /ID# 278128Verifierat postnummerClermont, United States· Rekrytering
- University of Florida College of Medicine /ID# 266930Verifierat postnummerGainesville, USA· Rekrytering
- Nature Coast Clinical Research - Inverness /ID# 265874Verifierat postnummerInverness, USA· Rekrytering
Vanliga frågor
What is a 'targeted therapy'?
Targeted therapies are medicines designed to home in on specific parts of the body that cause disease, rather than affecting the whole body. They try to be more precise.
How will I know which treatment I'm getting?
You'll be randomly assigned to one of the study treatments. This is like drawing names from a hat and helps ensure the study results are fair. The team will tell you which one you're on.
Will I have more hospital visits than usual?
Yes, taking part in this study will likely mean more regular visits to the hospital or clinic for check-ups and monitoring compared to your usual care.
Kan jag lämna studien om jag ändrar mig?
Absolutely. You can choose to leave the study at any time, for any reason, and your decision will not affect your ongoing medical care.
Vilka typer av tester kommer jag att ha?
You'll have regular medical checks, blood tests, and sometimes endoscopies. You'll also fill out questionnaires and keep a daily diary about your symptoms.
Hur du får reda på mer
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