19 results
The primary objective of this study is:To demonstrate that the percentage of patients who meet the adapted ACR Pediatric 30 criteria at Day 15 is higher with canakinumab compared to placebo.Secondary objectives of this study are:* To evaluate the…
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…
The primary objectives of this study are:Part II: to demonstrate that the time to flare in Part II is higher with canakinumab than with placebo.Part I: to assess if canakinumab allows tapering of steroids as per protocol in at least 25% of…
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.
Primary: Long term safety and tolerability.Secondary: Time to 1st flare, number and severity of flares, efficiacy in treating flares, effect on inflammatory markers, immunogenicity, PK.
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…
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 efficacy objective for this study was to evaluate the efficacy of gantenerumab compared with placebo administered to patients by subcutaneous (SC) injection over 100 weeks as measured by the following co-primary endpoints (final outcome…
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: 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…
This study will evaluate the efficacy and safety of gantenerumab compared with placebo in patients with early (prodromal to mild) Alzheimer's disease (AD).
In this study, we will evaluate a possible interaction between IMU-935 and midazolam. We will do this by investigating the effect of IMU-935 on how quickly and to what extent midazolam is absorbed, transported, and eliminated from the body. In…
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…
The main objective of this study is to continue to collect long-term safety and tolerabilitydata in participants with AD treated with gantenerumab. Specific objectives andcorresponding endpoints for the study are outlined in Table 1 of the protocol
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 primary objective for this study is to evaluate the safety, tolerability and efficacy of long-term gantenerumab administered by SC injection.
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)