A phase 2 randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of efgartigimod IV in adult patients with post–COVID-19 postural orthostatic tachycardia syndrome (POTS)
Aim: Efgartigimod is a neonatal Fc receptor (FcRn) antagonist in clinical development for treating autoimmune diseases mediated by immunoglobulin G (IgG) autoantibodies. POTS arising in patients after infection with the SARS-CoV-2 virus (COVID-19) may be caused by pathogenic IgG autoantibodies that lead to autonomic dysfunction. This phase 2 study will evaluate the efficacy and safety of Efgartigimod in participants with post–COVID-19 POTS.
Principal Investigator:Alexandru Barboi, MD, FACP
NorthShore Project Number:EH22-256
Contact:Please call 847.503.4344with questions regarding the study
Open to Enrollment:No
Repoce: A Phase 3, Multicenter, Efficacy and Safety of Pozelimab and Cemdisiran Combinations Therapy in Patients with Symptomatic Generalized Myasthenia Gravis
Aims: The primary purpose of this research study is to evaluate the effect of pozelimab and cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis.
Principal Investigator: Alexandru Barboi, MD, FACP
NorthShore Project Number: EH21-282
Contact:Please call 847.503.4333 with questions regarding the study
Open to Enrollment: Yes
A Long-Term Extension of ARGX-117-2002 Trial to Evaluate the Long-Term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults with Multifocal Motor Neuropathy (MMN)
Aims: This is an open-label extension trial of ARGX-117-2002. The objectives of the study include evaluating the safety and tolerability of ARGX-117 to evaluate the long-term efficacy of ARGX-117 on muscle strength and/or motor function, arm and hand function, quality of life and fatigue in adult participants with MMN.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH22-333
Contact: Call 847.503.4333 with questions regarding the study
Open to enrollment: No
Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Efgartigimod in Adult Patients with Post-COVID-19 Postural Orthostatic Tachycardia Syndrome (PC-POTS) Who Completed Study ARGX-113-2104
Aims: The primary objective of this study is to evaluate the long-term safety of efgartigimod in patients with PC-POTS. Secondary objectives include evaluation of the long-term efficacy of efgartigimod in reducing the severity of PC-POTS symptoms and the long-term efficacy of efgartigimod on patient global assessment of symptom experience, fatigue, and cognitive function.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH23-132
Contact: Call 847.503.4333 with questions regarding the study
Open to enrollment: Yes
A Phase 3, Multi-Center, Randomized Withdrawal and Long-Term Extension Study of Ampreloxetine for the Treatment of Symptomatic Neurogenic Orthostatic Hypotension in Participants with Multiple System Atrophy
Aims: The primary objective of this study is to evaluate the efficacy and durability of ampreloxetine in participants with multiple system atrophy (MSA) and symptomatic neurogenic orthostatic hypotension (nOH) compared with placebo over a double-blind, randomized withdrawal period of 8 weeks following an open-label period of 12 weeks. Secondary objectives, during the 8-week randomized withdrawal period, include evaluation of the efficacy and durability of ampreloxetine for symptomatic nOH in participants based on the Unified Multiple System Atrophy Rating Scale (UMSARS) Part IV.
Principal Investigator: Alexandru Barboi, MD
NorthShore Project Number: EH23-067
Contact: Call 847.503.4343 with questions regarding the study
Open to enrollment: Yes