Grevenbroich

Researchers are studying the effects of etrasimod as a treatment for adults with moderate to severe ulcerative colitis. The study aims to understand how etrasimod works in real-world medical practice for patients aged 18 to 64 who have not taken this medication before. Patients will be treated according to standard medical care, with etrasimod chosen as the best treatment option by their physician. All participants will receive etrasimod as prescribed in routine care. The study lasts for 52 weeks, followed by a 28-day safety follow-up. During this time, patients will visit their doctors as usual and complete health questionnaires on their own mobile phone, tablet, or computer at regular intervals. These questionnaires will help track their health and treatment effects. Participants will be assessed by comparing their disease activity before starting etrasimod to their progress during treatment. Data collected includes patient-reported outcomes via online questionnaires and clinical assessments done during regular doctor visits. The main outcomes measured are the proportion of patients who achieve symptom remission at 12 weeks and 52 weeks.

Researchers are investigating if combining mirikizumab with tirzepatide can reduce symptoms of moderately to severely active ulcerative colitis (UC) and help adults with obesity or overweight lose at least 10% of their body weight. This Phase 3b study compares this combination treatment to mirikizumab with a placebo to see which is more effective over a 52-week treatment period, followed by additional monitoring up to 61 weeks. Participants receive mirikizumab either intravenously (IV) or subcutaneously (SC), along with either tirzepatide or a placebo administered subcutaneously. The study randomly assigns adults with UC and obesity or overweight into these treatment groups to evaluate the effects over the full treatment duration. During the study, participants will undergo various assessments including evaluations of UC symptoms and body weight changes. Researchers will measure the percentage of participants who achieve clinical remission of UC and at least 10% weight loss at week 52. Safety and health monitoring will continue throughout the study to ensure participant well-being during the treatment and follow-up periods, which together can last up to 61 weeks.

Researchers are evaluating the effectiveness and safety of mirikizumab alone or combined with tirzepatide compared to mirikizumab with placebo in adults who have moderately to severely active Crohn's disease along with obesity or overweight conditions. This Phase 3b study focuses on patients with confirmed Crohn's disease or perianal fistulizing Crohn's disease who also meet specific weight-related criteria and have shown inadequate response or intolerance to previous Crohn's disease treatments. The study may last up to 61 weeks. Participants receive treatments involving mirikizumab administered intravenously or subcutaneously, tirzepatide given subcutaneously, or placebo administered subcutaneously. The trial includes groups receiving mirikizumab with placebo or mirikizumab combined with tirzepatide to compare outcomes. Dosage schedules and exact administration details are provided throughout the treatment period. During the study, participants will undergo various assessments including clinical evaluations using the Crohn's Disease Activity Index, endoscopic examinations, and monitoring of weight changes. Researchers will track the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight reduction by week 52. Safety and response to treatments will be closely monitored throughout the duration of up to 61 weeks.