9 results
The purpose of this open-label phase III extension study is to collect additional long term safety and efficacy data on canakinumab in the treatment of SJIA from patients who qualify to roll-over into this study from the CACZ885G2305 and…
Primary:To evaluate if the proportion of patients in clinical remission on canakinumab 4mg/kg (+/- concomitant NSAID only) who are able toremain on a reduced canakinumab dose (2mg/kg every 4 weeks) or prolonged canakinumab dose interval (4mg/kg…
The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…
Primary: To determine whether IL-1 inhibition by Canakinumab is efficacious in treatment of Schnitzler syndrome.Secondary:1. To assess the effect of canakinumab on Schnitzler syndrome (clinical signs/symptoms and inflammatory biomarkers C-reactive…
Primary: To characterize safety and tolerability of each treatment arm tested and identify recommended doses and regimens for future dosesSecondary:* To characterize the pharmacokinetic profile of each investigational drug within each treatment arm…
The objective of this study is:1. To evaluate the efficacy, safety and the tolerance of Canakinumab in 'IVIG-resistent' patients (cohort 1) and 'IVIG-naive' patients (cohort 2) with Kawasaki disease.2. To evaluate the incidence…
Primary: • To assess the Major Pathological Response (MPR) rate (<= 10% of residual viable tumor cells) on the resected specimen at the time of surgery in all subjects randomized to canakinumab alone or in combination with pembrolizumab.…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
Primary Objectives:* To study early (1 week after start of cCRT) and late changes (after finishing cCRT) in durvalumab (MEDI4736) uptake in tumor and metastatic lymph nodes during cCRT * To study early and late changes in durvalumab (MEDI4736)…