Phase IIa, Single-arm, Open-label, Multi-center Clinical Trial to Evaluate the Efficacy, Safety, and Tolerability of Intravenous Induction and Subcutaneous Maintenance Treatment With BI 3032950 in Patients With Moderate to Severe Ulcerative Colitis

This study is testing a medicine called afimkibart. Afimkibart is an investigational medicine being developed to treat Crohn’s Disease (CD). This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved afimkibart for treating CD.  This study aims to compare the effects of afimkibart as long-term treatment against ‘placebo’. A placebo is a medicine that contains no active ingredients but looks the same as the study medicine. Researchers want to see if afimkibart works, how well it works and how safe it is when given over a long period of time. This is compared to a placebo in people living with moderately to severely active CD.

This study is testing an investigational medicine called afimkibart. Afimkibart is an investigational medicine being developed to treat Crohn's disease (CD). This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved afimkibart for treating CD.  This study aims to compare the effects of afimkibart as long-term treatment against ‘placebo’. A placebo is a medicine that contains no active ingredients but looks the same as the study medicine. Researchers want to see if afimkibart works, how well it works and how safe it is when given over a long period of time. This is compared to a placebo in people living with moderately to severely active CD.

This study is testing an investigational medicine called afimkibart. Afimkibart is an investigational medicine being developed to treat ulcerative colitis (UC). This means health authorities (like the U.S. Food and Drug Administration and European Medicines Agency) have not approved afimkibart for treating UC.  This study aims to compare the effects of afimkibart as long-term treatment against ‘placebo’. A placebo is a medicine that contains no active ingredients but looks the same as the study medicine. Researchers want to see if afimkibart works, how well it works and how safe it is. This is compared to a placebo in people living with moderately to severely active UC.

This study is testing an investigational medicine called afimkibart.  Afimkibart is an investigational medicine being developed to treat ulcerative colitis (UC)  This study aims to compare the effects of afimkibart as long-term treatment against ‘placebo’. A placebo is a medicine that contains no active ingredients but looks the same as the study medicine. Researchers want to see if afimkibart works, how well it works and how safe it is when given over a long period of time. This is compared to a placebo in people living with moderately to severely active UC.

The study objective is to assess the efficacy, safety, and pharmacokinetics of an investigational drug in pediatric subjects from 2 to < 18 years of age with moderately to severely active Crohn’s disease (CD) who have had inadequate responses, loss of response, or intolerance to corticosteroids, immunosuppressants, and/or biologics, or in whom use of those therapies is medically contraindicated.

The LATITUDE UC Study is evaluating the efficacy and safety of an investigational oral treatment for ulcerative colitis (UC). Participants will receive the investigational treatment or a placebo (a substance that looks like the investigational treatment but does not contain any active ingredients) while completing various study tests and procedures.   

The LATITUDE CD Study is evaluating the efficacy and safety of an investigational oral treatment for Crohn’s disease. Participants will receive the investigational treatment or a placebo (a substance that looks like the investigational treatment but does not contain any active ingredients) while completing various study tests and procedures. 

The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

This research study examines the difference in Crohn's disease patient outcomes across several different mobile health applications. This represents the first randomized controlled trial of mobile health applications among Crohn's patients for managing their health and disease symptoms.