RecruitingPhase 2Phase 3NCT04833894

Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis

Open-label Uncontrolled Trial to Evaluate Pharmacokinetics, Pharmacodynamics, Safety, and Activity of Efgartigimod in Children From 2 to Less Than 18 Years of Age With Generalized Myasthenia Gravis


Sponsor

argenx

Enrollment

12 participants

Start Date

Oct 26, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this trial is to investigate the PK, PD, safety, and activity of efgartigimod IV in children and adolescents aged from 2 to less than 18 years of age with gMG. Trial details include: * The maximum trial duration for each individual participant will be approximately 28 weeks * The treatment duration will be 8 weeks for the dose-confirmatory part (Part A) and 18 weeks for the treatment response-confirmatory part (Part B)


Eligibility

Min Age: 2 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Efgartigimod IV for people with generalized myasthenia gravis. The study is currently recruiting participants at 25 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALEfgartigimod IV

Intravenous infusion of Efgartigimod


Locations(25)

Ann and Robert H Lurie Children's Hospital of Chicago - Main Hospital

Chicago, Illinois, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

University of Virginia (UVA) Health - Developmental Pediatrics Clinic

Charlottesville, Virginia, United States

Medizinische Universitat Wien

Vienna, Austria

Universitair Ziekenhuis Antwerpen

Antwerp, Belgium

Alberta Childrens Hospital

Calgary, Canada

British Columbia Children's Hospital

Vancouver, Canada

AP-HM - Hopital de la Timone

Marseille, France

Assistance Publique Hopitaux de Paris (AP-HP) - Hopital Necker-Enfants Malades

Paris, France

Vian - M. Iashvili Children's Central Hospital

Tbilisi, Georgia

Tbilisi State Medical University - Givi Zhvania Pediatric Academic Clinic

Tbilisi, Georgia

Charite Universitaetsmedizin Berlin - Campus Virchow-Klinikum - Sozialpadiatrisches Zentrum

Berlin, Germany

Universitätsklinikum Essen

Essen, Germany

Azienda Ospedaliera Universitaria Policlinico Consorziale Di Bari

Bari, Italy

Azienda Ospedaliero Universitaria A. Meyer

Florence, Italy

Ospedale Giannina Gaslini

Genova, Italy

Leids Universitair Medisch Centrum

Leiden, Netherlands

Uniwersyteckie Centrum Kliniczne

Gdansk, Woj. Pomorskie, Poland

Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Woj. Slaskie, Poland

Centralny Szpital Kliniczny - Uniwersyteckie Centrum Kliniczne WUM

Warsaw, Poland

Hospital Sant Joan de Deu

Esplugues de Llobregat, Spain

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, Spain

Great Ormand Street Hospital for Children NHS Foundation Trust - Great Ormond Street Hospital

London, United Kingdom

Manchester University NHS Foundation Trust - Royal Manchester Children's Hospital

Manchester, United Kingdom

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital Children's Hospital

Oxford, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT04833894


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