12 results
The primary objective of this study is to assess the pharmacokinetics (PK), pharmacodynamics (PD), safety, andefficacy of ALXN1210 in pediatric patients with paroxysmal nocturnal hemoglobinuria (PNH).
Primary:• To demonstrate the therapeutic equivalence of ONS-3010 (adalimumab biosimilar) compared toHumira® (adalimumab) in patients with plaque psoriasis Secondary:• To assess the safety, tolerability, and immunogenicity of ONS-3010 compared to…
PrimaryTo assess the efficacy of ravulizumab in the treatment of participants with TMASecondaryTo characterize TMA responseTo assess impact on hemoglobin levels To evaluate change in kidney function To assess duration of Complete TMA Response and…
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…
Part 1 - To determine the efficacy of oral BCX9930 monotherapy administered for 24 weeks, compared to continued complement component 5 (C5) inhibitor therapy, in subjects with paroxysmal nocturnal hemoglobinuria (PNH) with an inadequate response to…
a. Staging of women with breast cancer, particularly those with extensive carcinoma in situ (DCIS):1) The concordance of tumor extent between CEBCT and large section histopathology2) The non-inferiority of CEBCT to contrast enhanced breast MRI for…
To assess the efficacy of ravulizumab versus placebo in the treatment of adult and adolescent participants with HSCT-TMA.
We propose to perform a prospective trial to compare the accuracy of breast CT to the current standard imaging technologies for diagnosis of breast cancer in patients with a suspicious lesion identified during breast cancer screening.
Part A: Determine the performance of using 4D DCE-BCT for tumour staging. Part B: Determine the performance of 4D DCE-BCT in monitoring of treatment response and prediction of final treatment outcome based on early response in patients that undergo…
To evaluate the efficacy of ravulizumab compared with placebo to reduceproteinuria in adult participants with LN or IgAN.
Main objective:To assess the efficacy of ravulizumab compared with placebo in the treatment of gMG based on the improvement in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) profile.Secondary objectives:• To assess the efficacy of…
Sensitivity of CEBCT for DCIS when focal enhancement around calcifications is deemed positive, and no enhancement is regarded as a negative test outcome.