15 results
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…
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…
The primary objectives of this study are: - To evaluate the efficacy of GFT505 80mg and GFT505 120mg once daily (according to adaptive design, after 6-month interim safety analysis of the 80mg data on at least 50% of patients) for 52 weeks versus…
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…
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…
Voor meer informatie verwijs ik u naar sectie 2 in het protocol
Primary Objectives:Our primary objectives are:1. To evaluate the safety, tolerability and pharmacokinetics of intravenously (IV) administered M6229 in critically ill patients with sepsis with specific attention to anti-coagulation effects (based on…
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…
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 and 2.2
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.
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.
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 evaluate the efficacy of luspatercept on RBC transfusion independence (RBC-TI for 12 weeks [84 days] with an associated concurrent mean hemoglobin increase >= 1.5 g/dL) compared with epoetin alfa for the treatment of…