Phase IIa Clinical Trial to Evaluate BI 3032950 Infusion and Injection for Adults with Moderate to Severe Ulcerative Colitis

What this Trial Is About

This research aims to evaluate whether BI 3032950 helps adults aged 18 to 80 years who have moderate to severe ulcerative colitis and have not responded well or stopped previous treatments. The study is a Phase IIa clinical trial sponsored by Boehringer Ingelheim, focusing on the treatments efficacy, safety, and tolerability for this condition. The trial has two parts In Part A, participants receive BI 3032950 as an intravenous infusion every 4 weeks for 12 weeks. After this period, doctors assess improvements in symptoms and then participants move to Part B, where BI 3032950 is given as a subcutaneous injection every 4 weeks. Participants who show clinical response after 12 weeks can continue this subcutaneous treatment for up to 2 years. Participants visit their doctors every 4 weeks for assessments including symptom checks, blood and stool sample collections, and endoscopies to examine the colon. Researchers monitor the participants health and any side effects throughout the study. The main outcome measured is clinical remission using the modified Mayo Score up to Week 12, along with other measures like endoscopic remission and treatment-emergent adverse events.

A Study to Test Whether BI 3032950 Helps People With Ulcerative Colitis