8 results
Primary:To evaluate the effects of FF/UMEC/VI on lung function compared with FF/VI after 24 weeks of treatmentSecondary:To assess the efficacy (exacerbations), FEV1 3h post dose, asthma symptoms, safety and tolerability.
Protocol section 2.1 and 2.2
Effect on bone mineral density.
The objective is to assess the safety profile of the hypothermic Airdrive* oxygenated machine perfusion system for graft preservation in kidney transplantation.
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…