RecruitingPhase 2NCT06987539

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

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)

Sponsor

Amgen

Enrollment

15 participants

Start Date

Jul 21, 2026

Study Type

INTERVENTIONAL

Conditions

Generalized Myasthenia Gravis

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.

Eligibility

Min Age: 2 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Inebilizumab for people with generalized myasthenia gravis. The study is currently recruiting participants at 4 locations. People eligible for this study include aged 2 Years to 17 Years.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGInebilizumab

Inebilizumab will be administered IV.

Locations(9)

The Childrens Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Austin Neuromuscular Center

Austin, Texas, United States

Hospital Britanico de Buenos Aires

CABA, Buenos Aires, Argentina

Hospital Italiano de Buenos Aires

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Hospital Santa Izabel

Salvador, Estado de Bahia, Brazil

Hopital Armand Trousseau

Paris, France

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06987539

Related Trials

A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis

NCT0639238620 locations

Efficacy and Safety of Ravulizumab in Chinese Adults Participants With Generalized Myasthenia Gravis (gMG)

NCT07596784

Monitor the Evolution of Myasthenia Gravis Symptoms in Real-life in Patients With Anti-AChR and Anti-MUSK Generalised Myasthenia Gravis in Therapy With RYSTIGGO® (Rozanolixizumab)

NCT075705891 location

Clinical Study of Cizutamig in Generalized Myasthenia Gravis (gMG)

NCT072156501 location

ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod

NCT0728442024 locations