84 results
The primary objective of the study is to compare the efficacy of intravenous immunoglobulin product with the efficacy of antibiotic treatment in patients with recurrent respiratory infections and IgG-subclass deficiency and/or selective anti-…
Primary Objective(s)The primary objective is to evaluate the efficacy and safety of CNTO 136 administered intravenously in subjects with active, ISN/RPS Class III and IV LN.Secondary ObjectivesThe secondary objectives are:Evaluate the…
Primary: To assess the effect of UT-15C sustained release (SR) on exercise capacity compared to placebo (as measured by the change in 6-Minute Walk distance from Baseline to Week 16) in subjects with PAH.Secondary: To assess the effect of UT-15C SR…
To describe the safety and tolerability of up to 5 years denosumab administration as measured by adverse event monitoring, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab.
The main objective of this study is to further determine the efficacy of lapaquistat acetate 50mg compared to placebo during a period of 12 weeks. This period is followed by an optional 48 week open label extension to be able to study the long term…
Evaluate the efficacy and safety of treatment with CNTO 95 in combination with docetaxel and prednisone compared with docetaxel and prednisone without CNTO 95 in subjects with metastatic HRPC.
To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 10 days
To establish the safety, tolerability, and early efficacy of multiple doses of hLF1-11 given once daily for 14 days.
Primary:to examine the effect of co-administration with omeprazole on the pharmacokinetics of SSP-002358.Secondary:to provide additional safety information for SSP-002358 when administered alone or in combination with omeprazole.
Primary Objective:To assess the ability of BR55 to identify area(s) of VEGFR2 expression in human prostate by ultrasound molecular imaging on the basis of a visual score in comparison with histopathology analysis (location based on expression of…
The primary objective of the study is to assess the safety and immunogenicity of V212 in a population of adults with autoimmune disease.
To determine the effect of benralizumab on the rate of asthma exacerbationsSubstudy: - To assess the potential for benralizumab treated patients to reduce their standard of care asthma controller regimen whilemaintaining asthma control.- To assess…
Primary: To determine the safety and tolerability of CK3773274 in patients with symptomatic HCMSecondary: Assess long-term effects of CK3773274 on left ventricular outflow tract gradient (LVOT-G) in patients with oHCM
The primary objective of this feasibility study is to investigate the detection rate of SLNs using MR lymphography.
To evaluate the feasibility and prove the concept of sentinel node biopsy in patients with carcinoma of the parotid gland and scheduled for parotidectomy and elective neck dissection.
To assess the safety and tolerability of ascending doses of PP-001 whenadministered as a single intravitreal injection from 0,3 *g, 0,6 *g and 1,2*g with the option of an addition cohort with a dose of 2,1 *g PP-001.To assess the efficacy of…
PRIMARY OBJECTIVES- To investigate the PK profile of GLPG2451 administered as two doses of a capsule formulation in healthy subjects.- To assess the safety and tolerability of GLPG2451 administered as two doses of a capsule formulation in healthy…
The purpose of this study is to investigate the effect size in order to perform a power calculation for calculating a sample size for a powered RCT
Primary Objectives:* Identify the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D, 200mg BID) of TAS-119.
Primary: Safety and tolerability of fingolimod 0,5 mg.Secundairy: Long-term efficacy.Exploratory: Patient-Reported Outcomes Indices for Multiple Sclerosis (PRIMuS) and Short Form Health Survey*12 (SF-12), Treatment Satisfaction Questionnaire for…