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RECRUITING
NCT06987539
PHASE2

A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children With Generalized Myasthenia Gravis (gMG)

Sponsor: Amgen

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of inebilizumab administered in pediatric participants with gMG, and to assess the safety and tolerability of inebilizumab administered in pediatric participants with gMG.

Official title: A Phase 2 Open-label Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Inebilizumab in Children From 2 Years to Less Than 18 Years of Age With Generalized Myasthenia Gravis (gMG)

Key Details

Gender

All

Age Range

2 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2026-07-21

Completion Date

2030-03-13

Last Updated

2026-10-05

Healthy Volunteers

No

Interventions

DRUG

Inebilizumab

Inebilizumab will be administered IV.

Locations (13)

The Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Austin Neuromuscular Center

Austin, Texas, United States

Seattle Childrens Hospital

Seattle, Washington, United States

Hospital Italiano de Buenos Aires

CABA, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Instituto da Crianca - Hospital das Clinicas Fmusp

São Paulo, São Paulo, Brazil

Hopital Armand Trousseau

Le Kremlin-Bicêtre, France

Azienda Ospedaliera Universitaria Meyer

Florence, Italy

Medicover Integrated Clinical Services Spolka Z Ograniczona Odpowiedzialnoscia

Bydgoszcz, Poland

Lech Szczechowski Wielospecjalistyczna Poradnia Lekarska Synapsis

Katowice, Poland

Hospital Universitari i Politecnic La Fe

Valencia, Spain

John Radcliffe Hospital

Oxford, United Kingdom