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RECRUITING
NCT06607627
PHASE3

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

Sponsor: Alexion Pharmaceuticals, Inc.

View on ClinicalTrials.gov

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.

Official title: 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+)

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2024-11-13

Completion Date

2029-01-23

Last Updated

2026-04-01

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

Gefurulimab

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