5 results
Primary Objective(s)The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously in subjects with active, ISN/RPS Class III and IV LN.Secondary ObjectivesThe secondary objectives are:Evaluate the…
To assess the safety, tolerability and pharmacokinetic/-dynamic response, of single escalating doses of ADRECIZUMAB (0.5 mg/kg, 2mg/kg and 8 mg/kg administered as single infusion over 1 hour) in healthy male subjects.
Primary Objective:1. To assess the safety and tolerability of single escalating doses of Adrecizumab in healthy male volunteers during experimental endotoxemia.Secondary Objectives:2. To determine the pharmacokinetics of single escalating doses of…
Patients will be evaluated for safety and tolerability of the therapy, but also for signs of clinical efficacy. As long as the patients are on the ICU, measurements of clinical signs and laboratory data will be collected for safety reasons and for…
Part A: 52-week double-blind treatment phasePrimary* To investigate the efficacy of sirukumab (100 mg q2w for 12 months) as compared to placebo, each administered in addition to a 6-month prednisone treatment regimen Secondary* To assess cumulative…