9 results
Primary objective:Evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of multiple doses of intravenous (IV) ATYR1940 in adults 18 to 65 years of age, inclusive, with FSHDSecondary objective:Explore pharmacodynamic (PD)…
The objectives of the study are to: -To evaluate the safety and tolerability of MOTREM in patients with septic shock. -To evaluate the effects of MOTREM exposure over up to 5 days in patients with septic shock -To evaluate the PK/PD and dose/PD…
To demonstrate that crizotinib (Arm A) is superior to first-line chemotherapy, pemetrexed/cisplatin or pemetrexed/carboplatin (Arm B), in prolonging PFS in patients with advanced non-squamous NSCLC whose tumors harbor a translocation or inversion…
Primary objective: • To assess the efficacy of 2 different dosing regimens of subcutaneous GSK2402968 administered over 24 weeks in ambulant subjects with DMD.Secondary objectives:• To assess the safety and tolerability of 2 different dosing…
Primary: Part 1 • To determine the RP2D of avapritinib in patients with ISM for use in Part 2 and Part 3 of the study.Part 2 • To determine main change in ISM-SAF TSS from baseline to C7D1, compared to placebo. Part 3 • To assess the long-term…
The purpose of this study is to evaluate the effects of the addition of daratumumab to pomalidomide and dexamethasone in subjects with relapsed or refractory MM.1. Primary objectiveThe primary objective of this study is to compare PFS between…
From protocol amendment 3 27JUn2022, Clinical Study Protocol Synopsis, page 1Primary Objective• To demonstrate superiority of fianlimab 1600 mg + cemiplimab and/or fianlimab 400 mg+ cemiplimab compared to pembrolizumab, as measured by progression-…
Primary Objective:- Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)- antibody (Ab) seropositive population.Secondary Objectives:1…
Primary:• To compare progression free survival (PFS) between Arm A (ociperlimab in combination with tislelizumab) and Arm B (pembrolizumab followed by placebo) in the Intent to Treat (ITT) Analysis Set as assessed by investigators according to…