9 results
The objectives of the study are:To determine the pharmacokinetic and pharmacodynamic interaction of a single ascending dose of Xen2174 with bupivacaine, and in one cohort of Xen2174 alone, when administered intrathecally to healthy volunteers and…
The objectives of the study are:To determine the pharmacokinetic profile of Xen2174 in plasma and CSF when administered intrathecally to healthy volunteersTo determine which modalities of pain are affected by treatment with Xen2174 when administered…
To evaluate the overall safety and tolerability of intrathecally administered single ascending bolus doses of Xen2174 in healthy subjectsTo evaluate the effects of Xen2174, following its administration as a single intrathecal bolus, on EEG activity…
Primary objective: To demonstrate a clinically significant improvement in morning FEV1 in moderate to severe allergic asthmatics inadequately controlled by ICS therapy treated with QAW039 for 12 weeks compared to placebo.Secondary objectives:…
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…
Protocol section 2.1 and 2.2
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…