Phase 2b efficacy and safety study of JNJ-77242113 in participants with ulcerative colitis

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.

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.