14 results
Primary objective: To demonstrate a clinically significant improvement in morning FEV1 in moderate to severe allergic asthmatics inadequately controlled by ICS therapy treated with QAW039 for 12 weeks compared to placebo.Secondary objectives:…
In patients with severe asthma and high eosinophil counts (>=250 cells/µl) receiving SoC asthma therapy, to demonstrate the efficacy (as measuredby rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg…
Primary objective: To evaluate the efficacy of once daily doses of QAW039, as measured by EASI after 12 weeks of treatment, relative to placebo, in adult patients with moderate to severe AD. To evaluate safety and tolerability.Secondary objectives:…
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 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…
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…
Primary: Evaluate the efficacy of patient-derived tumor organoids to successfully allocate patients for treatment with specific targeted agents.Secondary: Characterize safety and tolerability per experimental treatment regimen.
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…
To evaluate in a feasibility study whether low uptake on FES-PET at baseline is related to non-response to letrozole plus palbociclib treatment.
The purpose of this study is to evaluate the efficacy and safety of fevipiprant 150 mg and 450 mg compared to placebo in the reduction of nasal polyps size and the effect on symptoms, quality of life and smell via patient-reported outcomes in…
The overall purpose of this study is to provide long-term safety data for fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care…
This study aims to investigate if fluorescence guided surgery performed with SGM-101 can improve R0 resection rates and allows to find additional malignant tissue in locally advanced and recurrent rectal cancer, or to achieve a *positive* change in…
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…