8 results
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (unkown status…
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Primary: treatment effect of BKM120 once daily plus weekly paclitaxel versus BKM120 matching placebo once daily plus weekly paclitaxel on progression-free survival for each of the two groups, namely 1) PI3K pathway activated patients and 2) full…
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…
Primary: To determine whether treatment with BKM120 plus fulvestrant prolongs PFS based on local investigator assessment compared to treatment with placebo plus fulvestrant for all patients regardless of PI3K pathway activation status (full…
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.…
Evaluate efficacy and safety of risankizumab compared to placebo in patients with severe persistent asthma over a 24-week treatment period.