10 results
Primary: Longterm safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
A clinical research study to find out if Xolair is safe and has beneficial effects in adolescents (12 years old and above) and adults with cystic fibrosis (CF) and ABPA. All patients entering the study will be taking oral corticosteroids (steroid…
Primary: To confirm that canakinumab 150 mg s.c. is superior to triamcinolone acetonide 40 mg i.m. with respect to patient*s assessment of gout pain intensity in the target joint at 72 hours post-dose (on a 0-100mm VAS). To confirm that canakinumab…
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,…
The primary objective of this study is to evaluate whether adding intensive local anti-inflammatory therapy (Triamcinolone injection therapy combined with 9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon dilatation reduces…
- 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…
4.1 Primary Objective• To determine the MTD and to establish the safety profile of enapotamab vedotin in a mixed population of patients with specified solid tumors. 4.2 Secondary Objectives• To evaluate the safety laboratory parameters of enapotamab…
The primary objective is, to determine whether short term anti-IgE treatment with an anti-IgE monoclonal antibody (omalizumab) can limit intraplaque mast cell activation in atherosclerotic plaques.
The purpose of this study is to establish efficacy and safety of ligelizumab in adolescent and adult subjects with CSU who remain symptomatic despite standard of care treatment by demonstrating better efficacy over omalizumab.
The primary objective is to find out whether ISI in children with EA can prevent refractory strictures from developing and consequently can reduce the total number of dilatations needed within 28 days interval.