Phase 2b efficacy and safety study of JNJ-77242113 in participants with ulcerative colitis
Ulcerative colitis causes painful inflammation and ulcers in the bowel. This study looks at whether a new medicine called JNJ-77242113 can help reduce this inflammation. The drug is taken as a daily tablet and works by targeting a specific protein involved in gut swelling. The trial is open to adults aged 18 and older who have moderate to severe ulcerative colitis. Participants will be placed into one of four groups to test three different doses of the medicine against a dummy pill (placebo). Neither you nor your doctor will choose your group. The study lasts up to 84 weeks in total and involves regular health checks, blood tests, bowel camera exams (endoscopy), and stool samples. You will be closely supported by a specialist care team, and your travel expenses will be reimbursed.
نظرة سريعة
ما هو موضوع هذه الدراسة؟
Ulcerative colitis is a long-term condition where the lining of the large bowel becomes swollen, inflamed, and develops tiny sores called ulcers. This can lead to frequent diarrhoea, tummy pain, bleeding, and deep tiredness. While there are treatments available today, they do not work for everyone, meaning new and easier options like daily tablets are always needed.
This trial is testing a new experimental medicine called JNJ-77242113. It is designed to block a protein in the body known as IL-23, which plays a major part in driving bowel inflammation. By calming this protein down, researchers hope the drug will help heal the gut lining, reduce flare-ups, and give people relief from troublesome daily symptoms.
Because this is a Phase 2 study, doctors need to find out how well the medicine works, what the best dose is, and how safe it is compared with a dummy treatment (placebo). Taking part helps researchers understand whether this tablet could become an effective future treatment for people living with ulcerative colitis across the UK.
النقاط الرئيسية
- Tests a new daily tablet designed to block inflammation in ulcerative colitis.
- Open to adults aged 18 and over with moderate to severe active colitis.
- Includes a dummy pill (placebo) group, but participants who do not improve can switch to the active drug.
- Involves regular clinic check-ups, blood and stool tests, and bowel camera exams.
- Participation is entirely voluntary and reasonable travel expenses are covered.
من قد يكون مؤهلاً؟
You may be able to join if you are 18 or older and have had a confirmed diagnosis of ulcerative colitis for at least 12 weeks. Your condition must currently be moderately to severely active, which will be confirmed using a camera examination of your bowel during screening. Depending on your age and how long you have had colitis, you may need an up-to-date colonoscopy check to ensure your bowel lining is safe to participate.
You will not be eligible if your colitis is only in your rectum (the very end of your bowel) or if you have had very severe complications, such as toxic megacolon or tears (fistulas) in your gut. You also cannot take part if you have a stoma bag, have had most of your large bowel removed, or have had recent major tummy surgery.
هل يمكن أن تناسبك هذه الدراسة؟
أجب عن هذه الأسئلة السريعة لترى ما إذا كنت مؤهلاً. هذا دليل فقط - الفريق البحثي هو الذي يتخذ القرار النهائي.
- عمري 18 عامًا أو أكثر.
- I have had a medical diagnosis of ulcerative colitis for at least 3 months.
- My colitis is currently flaring up or causing moderate to severe symptoms.
- I do not have a stoma bag or major bowel surgery history.
- My colitis affects more than just the very end of my bowel (rectum).
ماذا يتضمن المشاركة؟
Taking part lasts up to 84 weeks (about a year and a half) and is divided into four main stages. First, there is a screening period of up to 6 weeks to run checks and make sure the trial is safe for you. Next is a 28-week treatment period where you will take either the study drug (at one of three different doses) or a placebo tablet once a day. If you receive the placebo and your symptoms do not improve, you may be switched to the active medicine from week 16.
If the treatment helps you, you may be offered the chance to stay on it for another 48 weeks in an extended treatment phase. Finally, there is a 2-week safety follow-up after stopping the tablets. Throughout the trial, you will attend regular clinic visits for blood and stool tests, heart checks (ECGs), physical exams, and bowel camera tests (endoscopies) to track your gut health. All study medication and tests are free, and reasonable travel costs are reimbursed.
المخاطر والفوائد المحتملة
المواقع (9)
- St George's University Hospitals NHS Foundation Trustالمدينة فقطلندن، إنجلترا
- Northern Care Alliance NHS Foundation Trustالمدينة فقطBury, England
- Oxford University Hospitals NHS Foundation Trustالمدينة فقطأكسفورد، إنجلترا
- Guy's and St Thomas' NHS Foundation Trustالمدينة فقطلندن، إنجلترا
- مؤسسة مستشفيات جامعة كامبريدج التابعة لهيئة الخدمات الصحية الوطنيةالمدينة فقطكامبريدج، إنجلترا
- Kings College Hospital NHS Foundation Trustغير مؤكدلندن، إنجلترا
- St Helens and Knowsley Teaching Hospitals NHS Trustغير مؤكدPrescot, England
- مستشفى جامعة ساوثهامبتون التابعة لمؤسسة الخدمات الصحية الوطنيةغير مؤكدSouthampton, England
- مؤسسة بارتس الصحية التابعة لهيئة الخدمات الصحية الوطنيةغير مؤكدLeytonstone, England
أسئلة شائعة
What is a placebo and will I definitely get the real medicine?
A placebo is an inactive pill that looks just like the real drug. In the first 28 weeks, one in four participants will receive the placebo. However, if your symptoms do not improve by week 16, you will be switched to the active study drug.
How is the study medicine taken?
JNJ-77242113 is an oral tablet, meaning you take it by mouth with water, rather than having an injection or hospital drip.
Will taking part cost me anything?
No. The study medication, clinic appointments, and tests are provided free of charge, and you will be reimbursed for reasonable travel and parking expenses.
هل يمكنني مغادرة الدراسة إذا غيرت رأيي؟
Yes. Taking part is completely voluntary. You can withdraw at any point, and your usual medical team will continue to look after your health as normal.
What happens if my colitis gets worse during the trial?
Your health is closely tracked at every stage. If your symptoms worsen, the trial doctor will assess you immediately and can adjust or stop your treatment to ensure you stay safe.
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