9 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…
The primary efficacy variable is if the TachoSil application was feasible. A feasible application implies that the entire TachoSil adhere, TachoSil covers at least 1 cm beyond the margins of the anastomosis line and if more TachoSil sponges are used…
The primary objective of the study is to provide evidence that the use of a sealing surgical patch applied to the surgical field following parotidectomy is non-inferior in efficacy to the common practice of CSD insertion by wound closure, measured…
The aim of this study is to determine whether LNP023 is effective and safe for the treatment of PNH. LNP023 is compared to the Standard of Care (SOC) anti-C5 antibody treatment. The primary objectives are to:• Demonstrate superiority of LNP023…
Primary objective adults:To demonstrate the superiority of iptacopan (200 mg b.i.d.) compared to placebo in reducing proteinuria at 6 months of treatment.The primary clinical question of interest is:What is the effect of iptacopan vs. placebo on log…
The purpose of this study is to evaluate the long-term safety, tolerability and efficacy of iptacopan in patients with PNH and to provide access to patients who have completed the treatment extension period (without tapering down) of the Phase 2…
The primary objective is to evaluate the long-term safety and tolerability of iptacopan in eligible participants. The primary clinical question of interest is: what is the long-term safety and tolerability of iptacopan in IgAN participants including…
The purpose of the study is to evaluate the efficacy and safety of LNP023 compared to placebo on proteinuria reduction and slowing renal disease progression in primary IgAN patients
Participants enrolling from study CLNP023B12301 or CLNP023B12302• Primary Objective: To evaluate the long-term safety and tolerability of iptacopan in participants with C3G or IC-MPGN