RecruitingPhase 3NCT06607627

PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis

An Open-Label, Single-arm Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Safety, and Efficacy of Gefurulimab in Pediatric Patients (6 to < 18 Years of Age) With Generalized Myasthenia Gravis (gMG) Who Express Acetylcholine Receptor Antibodies (AChR+)


Sponsor

Alexion Pharmaceuticals, Inc.

Enrollment

12 participants

Start Date

Nov 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.


Eligibility

Min Age: 6 YearsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Gefurulimab for people with generalized myasthenia gravis and gmg. The study is currently recruiting participants at 13 locations. People eligible for this study include aged 6 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.

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Interventions

COMBINATION_PRODUCTGefurulimab

Combination product consisting of syringe prefilled with gefurulimab will be administered weekly via subcutaneous (SC) injection.


Locations(13)

Research Site

Washington D.C., District of Columbia, United States

Research Site

Norfolk, Virginia, United States

Research Site

Joinville, Brazil

Research Site

Salvador, Brazil

Research Site

São José do Rio Preto, Brazil

Research Site

São Paulo, Brazil

Research Site

São Paulo, Brazil

Research Site

Saitama-Shi, Japan

Research Site

Bydgoszcz, Poland

Research Site

Lodz, Poland

Research Site

Warsaw, Poland

Research Site

New Taipei City, Taiwan

Research Site

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT06607627


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