7 results
To determine effect of early (re) vaccinations after the current intensive chemotherapy for ALL. We will determine if there is a difference in respons to conjugated (T cell dependent) and polysaccharide (T cell independent) vaccines. This may result…
To assess the safety and tolerability of ascending doses of PP-001 whenadministered as a single intravitreal injection from 0,3 *g, 0,6 *g and 1,2*g with the option of an addition cohort with a dose of 2,1 *g PP-001.To assess the efficacy of…
Protocol section 2.1 and 2.2
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…
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 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…