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NCT06607627PHASE3Recruiting

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

Alexion Pharmaceuticals, Inc.

Start Date

11/13/2024

Completion Date

1/23/2029

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 Criteria

Age Range: 6 years to 17 years

Inclusion Criteria: United States of America (USA) specific inclusion criterion: * Participant must be 12 to \< 18 years of age at the time of signing the informed consent/assent. * All participants must be vaccinated against meningococcal infection from serogroups A, B, C, W, and Y within 3 years and at least 2 weeks prior to the first dose of study intervention administration. Rest of World (ROW) specific inclusion criteria: * Participant must be 6 to \< 18 years of age at the time of signing the informed consent/assent. * All participants must be vaccinated against meningococcal infection from serogroups A, C, W, Y (and B where available) within 3 years prior to study intervention on Day 1. If vaccination occurs \< 2 weeks prior to Day 1, the participants will receive prophylactic antibiotics for at least 2 weeks after initial meningococcal vaccination for serogroups A,C,W,Y (and B, where available) Global inclusion criteria: * Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV * Positive serological test for autoantibodies against AChR Exclusion Criteria: * History of thymectomy, or any other thymic surgery within 12 months prior to Screening * Untreated thymic malignancy, carcinoma, or thymoma * History of Neisseria meningitidis infection * Pregnancy, breastfeeding, or intention to conceive during the course of the study

Interventions

COMBINATION_PRODUCT

Gefurulimab

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Conditions

Generalized Myasthenia GravisgMG

Locations

Research Site

Washington D.C., District of Columbia 20010

United States

Research Site

Norfolk, Virginia 23507

United States

Research Site

Joinville, 89202-451

Brazil

Research Site

Salvador, 41253-190

Brazil

Research Site

São José do Rio Preto, 15090-000

Brazil

Research Site

São Paulo, 0438-002

Brazil

Research Site

São Paulo, 05403-000

Brazil

Research Site

Saitama-Shi, 330-8777

Japan

Research Site

Bydgoszcz, 85-065

Poland

Research Site

Lodz, 93-338

Poland

Research Site

Warsaw, 02-097

Poland

Research Site

New Taipei City, 23561

Taiwan

Research Site

Taipei, 11101

Taiwan