14 results
The main objective of this study is to investigate whether kidney transplant recipient suffering from a tacrolimus-induced tremor can benefit from switching from conventional tacrolimus to LCPT, a new extended release preparation of tacrolimus (…
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…
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…
To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.
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)
Primary objective:The objective is to evaluate if the LCPT dose can be reduced in comparison with tacrolimus-ER and still achieve similar tacrolimus levels in the therapeutic range in patients who are tacrolimus who need a relatively high dose of…
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…
The primary objective of this study is to investigate if the intra-patient variability in tacrolimus pharmacokinetics is reduced by switching patients from maintenance tacrolimus treatment with tacrolimus-Prograft to either Advagraf or to Envarsus.…
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…
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…
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…
To investigate whether Envarsus® leads to a significant reduction in new onset diabetes, chronic kidney disease and new onset hypertension.
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