13 results
To investigate the efficacy, safety, and pharmacokinetics of intravenous volasertib + subcutaneous low-dose cytarabine in patients * 65 years of age with previously untreated acute myeloid leukaemia, ineligible for intensive remission induction…
To determine if the addition of midostaurin to daunorubicin/ cytarabine induction, high dose cytarabine consolidation, and continuation therapy improves overall survival (OS) in both the mutant FLT3-ITD and FLT-3 TKD AML patients.
The primary objective for this study is as follows:Within the TP53 wild-type populationTo compare overall survival (OS) in patients with relapsed or refractory AML who havebeen randomized to idasanutlin in combination with cytarabine versus those…
Primary Objective- To assess efficacy and pharmacodynamic effects of topical omiganan BID Secondary Objectives- To assess safety and tolerability of topical omiganan BID
Primary Objective• To explore the pharmacodynamic effects of topically applied omiganan • To explore the treatment effect of omiganan compared to placebo in uVIN patients Secondary Objectives• To assess safety and tolerability • To explore the…
Primary objective• To explore the pharmacodynamic effects on a target lesion of topically applied omiganan in AD patientsSecondary Objectives• To assess safety and tolerability in AD patients• To evaluate the efficacy of omiganan compared to placebo…
Primary Objectives* To explore the pharmacodynamic effects of topically applied omiganan in patients with external genital warts* To explore clinical efficacy of omiganan compared to placebo in patients with external genital warts.Secondary…
Protocol section 2.1 and 2.2
Primary Objective* To explore the efficacy and pharmacodynamic effects of omiganan topical gel in facial seborrheic dermatitis Secondary Objectives* To explore skin and faecal microbiome in patients with seborrheic dermatitis * To evaluate the…
The primary objective is to estimate the effect of spesolimab compared to placebo for the mean percent change from baseline in total abscessand inflammatory nodule count at Week 12. Secondary objectives are the evaluation of efficacy of spesolimab…
To demonstrate that spesolimab is effective in maintaining Symptomatic Stenosis Responseand / or inducing Radiographic Stenosis Response (defined in Table 2.3: 1) in patients withsymptomatic CD-related small bowel stenosis, who have achieved…
The primary objective of the trial is to demonstrate a non-flat curve and evaluate the doseresponse relationship for 3 subcutaneous dosing regimens of BI 655130 (spesolimab) (with each regimen consisting of a single loading dose and a separate…
The primary objective of this trial is to assess the long-term safety of spesolimab in patients with HS who have completed the 1368-0052 PoCC trial and are qualified for entry into this trial. The secondary objectives are to evaluate efficacy at a…