A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
This study is investigating a new medication, Tulisokibart, for individuals in the UK who have Crohn's disease that is moderate to severe. Crohn's disease causes inflammation in the digestive tract, leading to symptoms like tummy pain and frequent bowel movements. The main goal is to find out if Tulisokibart can effectively reduce these symptoms and help heal the gut, compared to a placebo (a treatment with no active drug). Researchers will also be looking closely at any side effects to make sure the treatment is safe. Patients will receive the medication either directly into a vein (IV) or as an injection under the skin (SC). The study is divided into two parts, some participants will receive treatment for a shorter period, and others for longer, to understand its full impact.
At a glance
What is this study about?
This research is looking into a new medicine called Tulisokibart (MK-7240) for people living with Crohn's disease. Crohn's disease is a type of inflammatory bowel disease where parts of your digestive system become inflamed. This can cause various symptoms like tummy pain, diarrhoea, and feeling very tired. When these symptoms are moderate to severe, it can have a big impact on daily life.
The main purpose of this study is to see if Tulisokibart can help improve the symptoms of Crohn's disease and help the gut lining to heal. Researchers will compare Tulisokibart to a 'placebo', which looks exactly like the study drug but doesn't contain any active medicine. This comparison helps them understand if any improvements are truly due to the new medicine. The study will also carefully monitor any side effects to ensure the treatment is safe.
There are two main parts to this study. One part involves treatment for a longer period, including both an initial phase and an ongoing maintenance phase. The other part focuses on just the initial treatment phase. This allows researchers to gather detailed information about how well Tulisokibart works both immediately and over a longer time, and how safe it is when given either directly into a vein or as an injection under the skin.
Key takeaways
- This study is testing a new medicine called Tulisokibart for moderate to severe Crohn's disease.
- It aims to see if the medicine can reduce symptoms and help heal the gut.
- Some participants will receive the active medicine, while others will get a dummy treatment (placebo).
- You must have Crohn's disease and not have responded well to previous treatments.
- The study involves regular clinic visits for check-ups and assessments.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you must have been diagnosed with Crohn's disease at least three months ago, and your disease needs to be active, ranging from moderate to severe. It's also important that you haven't responded well to other common Crohn's treatments, or you couldn't tolerate them.
There are certain reasons why you might not be able to take part. For example, if you have other types of bowel inflammation like ulcerative colitis, or if your Crohn's disease only affects your stomach, first part of your small bowel, or around the back passage. You also can't participate if you have certain complications from Crohn's like an abscess that needs urgent attention, or if you've had major bowel surgery recently.
Other reasons that would mean you can't join include having certain infections like Hepatitis B, C, HIV, or active tuberculosis, or if you've had certain types of cancer in the last five years. The study is open to both men and women aged between 16 and 80 years old.
- I have been diagnosed with Crohn's disease for at least 3 months.
- My Crohn's disease is currently moderate to severe.
- Other Crohn's treatments haven't worked well for me, or I couldn't tolerate them.
- I am aged between 16 and 80 years old.
- I do not have other serious infections like Hepatitis B, C, HIV, or active TB.
- I haven't had certain types of cancer in the last 5 years.
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 given the study medication, Tulisokibart, in one of two ways: either directly into a vein (like a drip) or as an injection under the skin. Some participants will receive a placebo instead of the active drug. You'll have regular visits to the clinic for check-ups, assessments of your Crohn's symptoms, and to make sure the medication is safe for you. These visits will involve blood tests, physical exams, and potentially scopes to look at your bowel. The total duration of your participation will depend on which part of the study you are in, with some lasting longer than others.
Potential risks and benefits
Locations (499)
- Digestive Health Specialists ( Site 5064)Dothan, United States· Recruiting
- Arizona Arthritis & Rheumatology Research, PC ( Site 5094)Phoenix, United States· Completed
- GI Alliance - Sun City ( Site 5118)Sun City, United States· Recruiting
- University of Arizona Clinical and Translational Sciences Research Center ( Site 5111)Tucson, United States· Recruiting
- University of Arkansas for Medical Sciences ( Site 5147)Little Rock, United States· Recruiting
- Clinnova Research ( Site 5110)Anaheim, United States· Recruiting
- Southern California Research Center ( Site 5044)Coronado, United States· Recruiting
- Om Research LLC ( Site 5038)Lancaster, United States· Recruiting
- Cedars Sinai Medical Center ( Site 5080)Los Angeles, United States· Recruiting
- UCLA Clinical & Translational Research Center (CTRC) ( Site 5116)Los Angeles, United States· Recruiting
- University of California, Irvine (UCI) Health - UC Irvine Medical Center ( Site 5128)Orange, United States· Recruiting
- Om Research LLC ( Site 5045)Oxnard, United States· Recruiting
+487 more sites — see the official record for the full list.
Common questions
What is Crohn's disease?
Crohn's disease is a lifelong condition where parts of your digestive system become inflamed. It can cause tummy pain, diarrhoea, and tiredness.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but contains no active drug. It helps researchers see if the new medicine is actually making a difference.
How will the medicine be given?
The study medicine (Tulisokibart) will either be given into a vein (IV) or as an injection under the skin (SC).
Can I stop participating if I want to?
Yes, you can leave the study at any time, for any reason. Your decision will not affect your future medical care.
What age do I need to be to join?
You need to be between 16 and 80 years old to be considered for this study.
How to find out more
Toll Free Number
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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