14 results
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo as maintenance therapy in subjects…
The objective of this study is to evaluate the efficacy and safety of adalimumab 80 mg loading dose followed by 40 mg dose given every other week (eow) subcutaneously (SC) starting at Week 1 compared with placebo in subjects with inactive non-…
To assess the analgesic efficacy, safety, and tolerability of once daily orally administered GRT6005 in a total of 3 fixed doses (i.e., 200 µg, 400 µg, and 600 µg GRT6005) compared to placebo in subjects with moderate to severe chronic LBP.
This trial assesses the safety profile of GRT6005 in terms of its effect on respiratory function. Data on its effect on ventilation in a model of respiratory depression will be obtained and compared to fentanyl (a strong opioid with comparable…
With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigate…
To define and implement an uniform initial evaluation and stratification on adult patients with LCH, to uniform the treatment of adult patients with LCH and to improve treatment results with respect to survival, therapy response, prevention of…
To determine the efficacy (as assessed by rPFS) and safety of olaparib versus investigator choice of enzalutamide or abiraterone acetate in men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal…
Primary objective:To determine the equivalent dose of abiraterone when taken with a continental breakfast compared to 1000 mg in fasted stateSecondary objective:To evaluate the preference of the patients: intake of abiraterone with or without food
Primary objective: To determine the efficacy of the combination of olaparib and abiraterone vs placebo and abiraterone by assessment of rPFS (Radiographic progression-free survival) in patients with mCRPC (Metastatic castration-resistant prostate…
Primary Objectives:*To explore whether early abiraterone exposure (AUC) is corre*lated to treatment response after 3 months and 6 months of therapy (primarily based on radiographic response (RECIST re*sponse: SD, PR, CR) and secondary on…
To evaluate the effectiveness and safety of concentration controlled combination of once daily dosed low-dose sirolimus (trough levels: 3-5 ng/ml) and extended-release tacrolimus (trough levels:3-5 ng/ml), in order to provide superior renal function…
The purpose of this study is to determine whether 177Lu-PSMA-617, given for 6 cycles at a dose of 7.4 Gigabecquerel (GBq) (200 Millicuries (mCi)) +/- 10%, improves the radiographic progression free survival (rPFS) or death compared to a change in…
To compare pembrolizumab plus docetaxel plus prednisone to placebo plus docetaxel plus prednisone with respect to overall survival (OS)
- To compare the effect of capivasertib + abiraterone relative to placebo + abiraterone by assessment of radiographic progression-free survival PFS) in patients with PTEN-deficient mHSPC.