At a glance
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Proof-of-concept Study of BI 655130 add-on Treatment in Patients With Mild-to-moderately Active Ulcerative Colitis During TNF Inhibitor Therapy
In Brief
A Phase 2 clinical trial evaluating Spesolimab and Placebo for Colitis, Ulcerative. Completed, enrolled 22 participants across 16 sites in 6 countries.
Detailed Summary
The objectives of this trial are safety and efficacy (proof-of-concept) of induction of mucosal healing by BI 655130 add-on therapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activity despite pre-existing TNFi treatment. This trial will explore safety and efficacy of a dose of BI 655130 that was modelled to achieve the similar exposures as the highest exposures tested and found safe and tolerable in preceding single and multiple dose studies in healthy subjects, as add-on to pre-existing TNFi (Tumor necrosis factor inhibitor) treatment. Secondary and further objectives include assessment of the pharmacokinetic (PK) profile of BI 655130 and early exploration of specific biomarkers with potential usefulness to predict clinical efficacy or safety outcome or help understand BI 655130's mode of action.
Study Details
Timeline
Interventions
12 weeks treatment
12 weeks treatment