12 results
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…
Part BPrimary:• To determine the anti-tumor activity of NM21 1480 according to RECIST 1.1• To assess the safety and tolerability of NM21 1480 in patients with selected advanced cancers treated at or around the recommended Phase 2 dose (RP2D)• To…
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 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…
To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.
To determine whether 4 weeks of total antibiotic treatment duration is non-inferior to 6 weeks in patients with complicated SAB who have responded well to the initial treatment.
The purpose of this study is to investigate the effects of the new compound efgartigimod on IgG antibodies. It will also be investigated how quickly and to what extent efgartigimod given together with rHuPH20, is absorbed and eliminated from the…
The purpose of this study is to investigate the effect of the study compound efgartigimod on the immune system's response to vaccination with Pneumovax 23. We also investigate how safe efgartigimod is and how well it is tolerated when it is…
The purpose of this study is to compare administration of efgartigimod under the skin (subcutaneously/SC) to administration directly into a blood vessel (intravenously/IV). This is being studied to compare if subcutaneous injection is equally safe…
Primary Objective:* To evaluate the long-term safety of efgartigimod in adult patients with primary immune thrombocytopenia (ITP).Secondary Objectives:First 52-week treatment period only:* To evaluate the long-term efficacy of efgartigimod on…
Primary Objective:- To evaluate the efficacy of efgartigimod compared to placebo in achieving a sustained platelet count response in patients with chronic primary immune thrombocytopenia (ITP), with a sustained platelet count response defined as…
To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP