12 results
Objectives1.3.1 Primary ObjectiveCompare the efficacy of BMS-945429 versus placebo for induction of clinical remission (defined by an absolute Crohn*s Disease Activity Index [CDAI] score < 150) at Week 8 (IP-57).1.3.2 Secondary Objectives•…
To explore, whether the magnitude of the effect - in terms of progression free survival at one year - due to the addition of SABR after chemotherapy for selected patients with metastatic disease from solid (non-germinoma) tumours might justify a…
The primary objective of this study is to test safety and performance of the APD Perfusion Measurement Catheter & Monitor for the measurement of gut perfusion in humans. The secondary objectives of this study are to assess the normal values…
To provide single dose PK/PD dataTo investigate tolerability and safety of dabigatran etexilate solution in children1 to <12 years of age
To determine long-term outcome of patients with advanced non-squamous NSCLC harbouring at diagnosis EGFR mutations with and without T790M mutation and treated with the combination of erlotinib and bevacizumab.
Primary objective:To assess the effects of fenretinide on hepatic and peripheral insulin sensitivity in obese, insulin resistant subjectsSecondary objective:To assess the effects of fenretinide on hepatic steatosis, body weight and body fat…
The aim of this study is to (i) determine if tumor hypoxia can be accurately visualized with [18F] HX4 PET imaging in Cervix tumors (ii) correlate the [18F] HX4 PET images with blood and tissue markers and (iii) investigate the quality and optimal…
Primary: To demonstrate the efficacy of QGE031 relative to placebo at 12 weeks in patients withatopic dermatitis (AD) as assessed by Eczema Area and Severity Index (EASI).Secondary: efficacy assessed by Investigator Global Assessment (IGA, 12 weeks…
Study AimsPrimary Aim: This is a proof-of-concept study to evaluate the effect of ARA 290 in pain of patients with CRPS1 by means of once daily subcutaneous injection with ARA 290 for 4 weeks. Secondary Aims: * Assess the predictive effect of…
- To assess the safety and tolerability of escalating single and multiple IV doses of SAR228810 in AD patients- To evaluate the pharmacokinetic properties of SAR228810 in plasma and CSF after escalating single and multiple IV doses of SAR228810 in…
2.1 Primary objectiveTo assess the rate of no progression (NPR) at 8 weeks following treatment with the combination of gefitinib and fulvestrant in EGFR mutated patients who failed previous treatment with reversible EGFR TKI*s (gefitinib or…
Primary: efficacy of belimumab for the treatment of IMN.Secondary: safety and tolerability, PK, PD, quality of life, benefit of earlier treatment initiation.