18 results
Primary objectiveThe primary objective of this study is to evaluate the efficacy of bimekizumab in subjects with moderate to severe HS.Secondary objectiveThe secondary objective of this study is to assess the safety, tolerability, immunogenicity,…
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…
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…
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 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…
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)
To confirm an age-adjusted optimum dose of efgartigimod IV and provide (model-predicted) evidence for a treatment response.
In this open-label extension study, we look at how safe and effective the new medicinal product called bimekizumab (hereafter called the *study drug*) is for long-term treatment of hidradenitis suppurativa. Open label means that both you and your…
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously (sc) every 4 weeks (Q4W) compared to placebo in the treatment of subjects with active ankylosing spondylitis (AS).…
Primary Objective:The primary objective of this study is to compare the efficacy of bimekizumab administered scfor 16 weeks versus secukinumab at achieving complete clearance (PASI100) in subjects withmoderate to severe chronic plaque PSO.The…
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…
Objective(s): Primary objective:The primary objective is to demonstrate the efficacy of bimekizumab administered subcutaneously every 4 weeks (sc Q4W) compared to placebo in the treatment of subjects with active nr-axSpA.Secondary objectives:The…
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…
The purpose of this study is to find out how safe and effective a new drug called bimekizumab is for long-term use in treating hidradenitis suppurativa. Bimekizumab (hereafter referred to as *the study drug*) has been approved by the health…
The primary objective of this open-label extension (OLE) study is to assess the long-term safety and tolerability of bimekizumab administered over a period of up to 112 weeks.
To assess the long-term safety and tolerability of treatment with efgartigimod PH20 SC in participants with BP
The purpose of this first-in-human study is to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple ascending doses (MADs) of DYNE-101 administered intravenously (IV) to participants with DM1.…