15 results
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 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…
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…
Voor meer informatie verwijs ik u naar sectie 2 in het protocol
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 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…
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.
Primary objective The primary objective of this clinical trial is to demonstrate the superior efficacy of bococizumab compared with placebo in reducing the risk of major CV events, a composite endpoint which includes adjudicated and confirmed CV…
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…
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.
Protocol section 2.1 and 2.2
The objective of this study is to assess the long-term safety of linaclotide in pediatric participants with FC (total exposure with linaclotide for 24 weeks) or IBS-C (total exposure with linaclotide for 52 weeks) who have completed study…
To evaluate the safety and efficacy of 12 weeks of linaclotide therapy in comparison with placebo in pediatric participants aged 6 to 17 years who fulfill modified Rome III Criteria for Child/Adolescent FC