Mullingar

This trial investigates the safety and effectiveness of risankizumab compared to vedolizumab in adults with moderate to severe ulcerative colitis (UC) who have not previously received targeted therapies. Ulcerative colitis is an inflammatory bowel disease causing inflammation and bleeding in the rectum and colon. The study is a Phase 3b, randomized, open-label trial enrolling about 530 participants across 285 sites worldwide. Participants will be randomly assigned to receive either risankizumab or vedolizumab. Those in the risankizumab group will receive the drug intravenously during the initial induction phase, followed by subcutaneous injections for maintenance. Participants in the vedolizumab group will receive the drug intravenously throughout the study. The treatment period lasts 44 weeks for risankizumab and 46 weeks for vedolizumab, following a screening period of up to 35 days. During the study, participants will attend regular outpatient visits for medical assessments, side effect evaluations, and to complete questionnaires. Researchers will monitor disease activity and drug safety, focusing on the percentage of participants achieving endoscopic improvement by week 48. The total study duration is approximately 69 weeks for risankizumab and 71 weeks for vedolizumab recipients.

Researchers are evaluating targeted therapies for adult participants with moderate to severe Crohn's disease, a chronic condition causing severe inflammation in the digestive tract. This disease often leads to symptoms like belly pain, diarrhea, tiredness, and weight loss. The study aims to assess the effectiveness and side effects of several targeted treatments, as current therapies may not work equally well for all patients or may lose effectiveness over time. This is a Phase 2a multicenter, randomized platform study enrolling around 540 adults across approximately 300 sites worldwide. The treatments being studied include risankizumab, trosunilimab, lutikizumab, and ABBV-8736. These therapies are administered either as injections under the skin or infusions into the vein, depending on the drug. Participants will be randomly assigned to one of the treatment groups. The study will involve regular visits to hospitals or clinics where participants receive their assigned treatments and are monitored throughout the study period. Participants will undergo medical assessments including blood tests and endoscopies to check the status of their disease and to monitor for any side effects. They will also complete questionnaires and keep a daily diary to track their condition. The main outcome measured is the percentage of participants who achieve endoscopic remission by week 12. The study involves careful safety monitoring and aims to provide detailed data on the treatments over the course of the trial.