4 results
To relate the reduction of inflammatory characteristics in skin and in peripheral blood to clinical efficacy in patients with CSU. Major focusses of this study are the (early) effects on basophils and other Fc*RI-bearing leukocytes before, during,…
- To evaluate the safety and efficacy of anti-IgE therapy with respect to:Clinical disease activity (DAS44), laboratory parameters and adverse events. - To evaluate whether disease activity correlates with immunological parameters, including…
see protocol summary
Primary:To assess the safety and tolerability of Firdapse after single and multiple doses Secondary:Part 1 only: To determine the dose-related PK profile of single, escalating doses of Firdapse;Part 2 only: To assess the steady-state plasma PK and…