7 results
Primary Objectives: • To evaluate the safety and tolerability of ascending doses of KER 047 in participants with iron-refractory iron deficiency anemia (IRIDA)Secondary Objectives:• To evaluate the pharmacodynamic (PD) effects of KER 047 on iron…
The main reason for this study is to help in answering the following research question: - Whether mirikizumab can help patients with Crohn*s disease when taken for a longer time. - How safe mirikizumab is and whether you might have any side effects…
The primary goal is to investigate whether controlled dose reduction of IL17 or IL23 inhibiting biologics is not inferior compared to usual care. This is measured by comparing the proportion of long-term disease flares between the two groups (dose…
Study M16-066 comprises three sub-studies:Sub-study 1: Randomized, double-blind, placebo-controlled maintenanceTo evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active…
Study AMAP is a single-arm, outpatient, open-label, Phase 3, multicenter, long-term extension study evaluating the efficacy and safety of mirikizumab in patients with moderately to severely active UC who have participated in an originator…
Sub-study 1: The objective of sub-study 1 is to evaluate the efficacy and safety of risankizumab versus placebo as maintenance therapy in subjects with moderately to severely active Crohn's disease (CD) who responded to risankizumab induction…
Part 1:The objective is to compare the efficacy and safety of risankizumab versus ustekinumab over 48 weeks for the treatment of adult subjects with moderate to severe Crohn's Disease (CD) who have failed anti-TNF therapy.Part 2:The objective…