Grevenbroich

Researchers are evaluating how well guselkumab works compared to risankizumab in adults with moderately to severely active Crohns Disease, a long-term condition causing severe inflammation in the intestinal tract. This Phase 3b study aims to compare the effectiveness and safety of these two drugs for treating this condition. Participants will be randomly assigned to one of two groups. One group will receive guselkumab with induction doses given under the skin at Weeks 0, 4, and 8, followed by maintenance doses every 4 weeks from Week 12 through Week 52. The other group will receive risankizumab with induction doses given intravenously at Weeks 0, 4, and 8, followed by maintenance doses under the skin every 8 weeks from Week 12 through Week 52. During the study, participants will be monitored for up to about three years to assess deep remission at Week 52 and other clinical outcomes such as clinical remission, endoscopic response, steroid-free remission, and safety measures including laboratory tests and adverse events. The study includes ongoing safety monitoring through Week 165 with regular assessments to track disease activity and treatment effects.

This research aims to learn about the effects of etrasimod as a treatment for adults aged 18 to 64 with moderate to severe ulcerative colitis. Patients included have not taken etrasimod before and are prescribed this treatment based on their physicians judgment as the best option. The study is observational and non-interventional, focusing on real-world use of etrasimod. All participants will receive etrasimod according to standard medical care. The study does not change treatment schedules but includes regular health questionnaires completed online by patients using their own devices. The treatment and assessments follow usual care practices throughout the 52-week study period, followed by a 28-day safety follow-up. Participants will visit their doctors as usual and complete health questionnaires regularly via a mobile phone, tablet, or computer. Researchers will compare each patients disease activity before and after starting etrasimod, focusing on symptomatic remission and clinical response at weeks 12 and 52. Safety is monitored during and after treatment, with the total participation lasting about one year and one month.

Researchers are evaluating whether treatment with both mirikizumab and tirzepatide compared to mirikizumab and placebo can reduce or eliminate symptoms of moderately to severely active ulcerative colitis UC in adults who are also overweight or have obesity. This Phase 3b randomized controlled study aims to determine if this combination treatment leads to clinical remission and at least a 10% reduction in body weight. Participants receive mirikizumab initially by intravenous IV infusion followed by subcutaneous SC injections. They are randomly assigned to receive either tirzepatide SC or a placebo SC alongside mirikizumab. The treatment period lasts for 52 weeks, with the whole study participation lasting up to 61 weeks. Both study drugs and placebo are administered under medical supervision. During the study, participants are monitored regularly for symptom improvement and weight loss. Researchers assess clinical remission, endoscopic response, histologic-endoscopic mucosal improvement, bowel movement urgency, and histologic remission at weeks 24 and 52. Safety and treatment effects are carefully followed throughout the trial. Participants undergo evaluations to measure changes in UC symptoms and body weight over the study period.

Researchers are evaluating the effectiveness and safety of mirikizumab combined with either tirzepatide or a placebo in adults with moderately to severely active Crohns disease who also have obesity or are overweight. This Phase 3b study aims to compare these treatments in participants who have a confirmed diagnosis and meet specific disease activity and weight criteria. The study is conducted by Eli Lilly and Company and lasts up to 61 weeks. Participants receive mirikizumab initially via intravenous infusion, followed by subcutaneous injections. They are randomly assigned to receive either tirzepatide with mirikizumab or placebo with mirikizumab, both administered subcutaneously. The study involves two experimental groups where treatments are given according to this schedule. During the study, participants will undergo regular assessments to monitor clinical remission using the Crohns Disease Activity Index and endoscopic remission, as well as track weight reduction. Evaluations include inflammatory bowel disease questionnaires and monitoring of corticosteroid use. The main measure is the percentage of participants achieving clinical remission, endoscopic remission, and at least 10% weight loss by week 52. Safety and maintenance of remission are also assessed throughout the trial.