11 results
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…
To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.
Primary objective:- To assess the clinical efficacy of efgartigimod IV 10mg/kg administered in a q2w continuous regimen compared to that administered in a cyclic regimen.Secondary objectives:- To evaluate the safety and tolerability of both…
Parts A and B:To evaluate the efficacy of efgartigimod PH20 SC on achieving sustained remission in the treatment of participants with bullous pemphigoid (BP)
The current study is designed to evaluate the preliminary safety and efficacy of BLU-263 in patients with AdvSM, including in those with high and very high-risk SM-AHN, in whom HMAs, and azacitidine specifically, are the standard of care. Dose…
The aim of this trial is to investigate the long-term safety, tolerability, and immunogenicity of efgartigimod administered intravenously (IV) in pediatric participants rolling over from the ARGX-113-2006 trial and to ensure access to the drug…
Primary objective: To investigate the clinical effectiveness of the novel anal insert (Navina* Fecal Incontinence Insert) in ambulatory patients with faecal incontinence in comparison to care as usual (e.g. incontinence pads)Secondary objectives:1.…
To determine RD of BLU-263To assess if treatment with BLU-263 improves outcomes compared to placebo + BSC, as assessed using the ISM-SAFTo assess the long-term safety and tolerability of treatment with BLU-263To assess the long-term efficacy of…
To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP
Main objective:- To evaluate the long-term safety and tolerability of ARGX-113 in acetylcholine receptor antibody (AChR-Ab) seropositive patients.Secondary objective:- To evaluate the long-term safety and tolerability of ARGX-113 in the overall…
The VOLT CE Mark study will collect data to demonstrate that the Volt PFA System is functioning as intended in a clinical setting and to demonstrate acute safety and effectiveness for the treatment of symptomatic, recurrent paroxysmal atrial…