15 results
To assess the effect of ACZ885 on AAA size and growth rate as measured with ultrasound at 12 months.Secondary Objectives * To assess the safety and tolerability of monthly 150 mg subcutaneousdoses of ACZ885 in subjects with AAA over a treatment…
This study is designed as a proof-of-concept to assess if inhibition of IL-1* by canakinumabwill improve lung function in association with attenuation of tissue inflammation in patientswith chronic sarcoidosis, therefore allowing further development…
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 demonstrate the superiority of at least one dose of canakinumab compared to placebo in reducing the risk of recurrent major cardiovascular disease events (cardiovascular death, non-fatal MI and stroke) in a population of clinically…
A study to investigate the safety, pharmacokinetics and pharmacodynamics of a new recombinant human factor VIIa in healthy males, compared to Novoseven.
- to evaluate the FVIIa activity PK of 2 CSL689 dose levels in subjects with congenital FVII deficiency- to determine the PK characteristics of FVIIa activity of CSL689- to evaluate the safety and tolerability of intravenous administration of CSL689
Primary: The primary objective of the randomized treatment epoch and for the overall study is to demonstrate that subcutaneous canakinumab administered every 4 weeks is superior to placebo in achieving a clinically meaningful reduction of disease…
Primary Objective:- To assess the efficacy of escalating doses of ANF-RHO versus Neulasta in the duration of neutropenia grade 1 or worse (absolute neutrophil count [ANC] * 2.0 x 109/L) in the first chemotherapy cycle (21-day cycle FE100C).Secondary…
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…
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…
Primary: Safety run-in part (part 1):• Recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with pembrolizumab plus chemotherapy. Double-blind, randomized, placebo-controlled part (part 2):• Progressive free survival (PFS) between…
Primary: Safety run-in part (part 1):* to confirm tthe recommended Phase 3 dose regimen (RP3R) of canakinumab in combination with docetaxel. Double-blind, randomized, placebo-controlled part (part 2):* to compare the overall survival (OS) between…
The study will be performed in 2 parts, Part 1 and Part 2. Part 2 has been clinically completed. The remainder of this document concerns Part 1 only. The purpose of Part 1 of this study is to determine the reversal of the blood thinning effects of…
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)