14 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…
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…
The primary objective of this study is:• To evaluate the non-inferiority of switching to a TAF Containing STR relative to maintaining TDF Containing Regimens in Virologically Suppressed HIV-1 positive subjects as determined by having HIV 1 RNA * 50…
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: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…
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 primary objective of this study is:• To evaluate the efficacy of a single-tablet regimen (STR) containingelvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) versus a STRcontaining elvitegravir/cobicistat/emtricitabine/…
Primary objective:To assess the bioequivalence of single dose STB after administration of standardized breakfast followed by a whole tablet (reference) and a crushed and suspended tablet (intervention I).To assess the bioequivalence of single dose…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
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.…
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…
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…