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Patients receiving efgartigimod intravenous (IV) treatment

Efgartigimod IV

Sabine Coppieters, MD

Nancy Kuntz, MD

James Howard, MD

Anna Jesus, MD

Diane Beysen, MD

Kathryn Selby, MD

Brigitte Chabrol, MD

Isabelle Desguerre, MD

Nino Tatishvili, MD

Sophia Bakhtadze, MD

Corinna Stoltenburg, MD

Adela Della Marina, MD

Emilia Matera, MD

Renzo Guerrini, MD

Chiara Fiorillo, MD

Erik Harmen Niks, MD

Maria Mazurkiewicz-Beldzinska, MD

Marek Smilowski, MD

Anna Kostera-Pruszczyk, MD

Andres Nascimento, MD

Teresa Sevilla Mantecón, MD

Pinki Munot, MD

Mary Imelda Hughes, MD

Sithara Ramdas, MD

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)

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

Blood samples will be collected from each participant for measurement of serum concentrations of efgartigimod

Total Immunoglobulin G levels will be measured from blood samples

Total Immunoglobulin G (IgG) levels will be measured from blood samples

Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems in any of the 5 dimensions and 33333 would indicate worst problems in any of the 5 dimensions.

Description of the participant's health state is done by digits for 5 dimensions combined in a 5-digit number. A unique health state is defined by combining 1 level from each of the 5 dimensions. Each state is referred to in terms of a 5-digit code, whereas code 11111 would indicate no problems and 33333 would indicate worst problems in any of the 5 dimensions.

argenx

Spots Global Cancer Trial Database for efgartigimod iv