16 results
Objectives:Primary Objectives:1. To evaluate the efficacy of BAN2401 compared to placebo by establishing the ED90 (as defined in theprotocol) for BAN2401 on the derived Composite Clinical Score at 12 months of treatment in subjects withEarly…
the main objectives of the study are to evaluate the efficacy of different doses of BI655066 + to evaluate the pharmacokinetics (how the body handles the study drug) and pharmacokinetics (interaction of the study drug with the body) for subjects…
The overall purpose of the trial is to assess clinical efficacy and safety of three different doses of BI 655066 administered by multiple subcutaneous injections in adult patients with defined ankylosing spondylitis. We will also explore its…
This study has two parts. The main purpose of Part 2 of this study is to see how safe and effective different doses of BI 655064 are as well as to look at the pharmacokinetics (the amount of medication in your blood) and the pharmacodynamics (the…
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of tosedostat added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
Primary objective:To assess and compare the effects of aliskiren/amlodipine and amlodipine on pedal edema after 4 weeks of treatment as measured by ankle foot volume (AFV) (water displacement method) in patients with mild to moderate hypertension.…
To describe the pharmacokinetic (PK) profile and effectiveness of sarilumab in patients with pcJIA in order to identifythe dose and regimen for continued development in this population.
Primary objective:To explore the natural time course of specific [18F]AV-1451 binding in patients with subjective cognitive decline after two and four year follow upa. To compare rate of change in [18F]AV-1451 binding according to baseline amyloid…
Voor meer informatie verwijs ik u naar sectie 2 in het protocol
Primary objectivesPart A of the study (if applicable):1. To assess the safety and tolerability of selinexor added to standard induction chemotherapy for AMLand select the feasible dose level for part B of the study2. To assess in a randomized…
To assess efficacy of INCMGA00012 in terms of the ORR in participants with locally advanced or metastatic SCAC who have progressed after platinum-based chemotherapy.
see section 21 & 2.2This trial aims to prove the concept of induction of mucosal healing by BI 655130 add-ontherapy in patients with mild or moderate ulcerative colitis and persisting endoscopic activitydespite pre-existing TNFi treatment.…
Protocol section 2.1:* Demonstration of the long term safety of BI655130 in patients with moderate to severe active colitis Ulcerosa who have already been treated in previous studies.* Demonstration of the long term efficacy of BI655130 in patients…
The goal of the trial is to investigate the safety and efficacy of SAR566658, if it is provided to CA6 protein positive metastaticTBN breastcancer patients.
The main objective of the present study is to investigate the association between in vivo regional synaptic loss ([11C]UCB-J PET), in vivo regional tau pathology ([18F]flortaucipir PET) and in vivo regional Aβ pathology ([18F]florbetapir PET).…
Protocol section 2.1 and 2.2