21 results
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: 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…
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…
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 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 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: 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 objectives of the study are:* To evaluate the safety and tolerability of zilucoplan in subjects with IMNM* To evaluate the efficacy of zilucoplan in subjects with IMNM
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…
1. To assess safety of different doses of a single iv injection of SGM-1012. To assess the performance of SGM-101 in the intraoperative detection of colorectal or pancreas cancer by:a. Tumor-to-background ratio (TBR);b. Concordance between…
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…
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…
1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal lung metastases - Concordance between fluorescent signal and tumor status of resected tissue2. To define the optimal dose of SGM-101 for intraoperative imaging of…
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…
The main objective is to investigate the feasibility of a tumour-targeted fluorescent tracer SGM-101, combined with the use of the CE-marked fluorescence-laparoscope of Quest Medical Imaging, to discriminate between normal, LGD and malignant tissue…
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.…
The primary objective of this clinical trial is to assess the performance of SGM-101 in theintraoperative detection of resection margins and metastases in patients undergoing curativesurgery for colorectal cancer. SGM-101 will be administered as a…
To evaluate the efficacy of each combination arm, as measured by confirmed objective response rate (ORR)
This study evaluates the yield of NIR-Fluorescence imaging as additional surgical-tool for visualization and assessment of local extent and resectability status of neoadjuvant treated localized pancreatic tumors, local lymph node-involvement as well…
1. To determine the feasibility of SGM-101 for intraoperative imaging of colorectal brain metastases - Concordance between fluorescent signal and tumor status of resected tissue- Concordance between the fluorescent signal and the resection margin…