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

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Alexion Pharmaceuticals, Inc.
Study ID
NCT06607627
Phase
PHASE3
Status
Recruiting
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Conditions

  • Generalized Myasthenia Gravis
  • gMG

Eligibility Criteria

Sex
ALL
Age
6 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Nov 13, 2024
Status verified
Mar 2026
Primary completion
Dec 15, 2026
Completion
Jan 23, 2029

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gefurulimab
    On Day 1, participants will receive a weight based loading dose followed by a weekly maintenance dose for up to 122 weeks.

Primary Outcome Measure

Maximum Observed Serum Concentration (Cmax) of Gefurulimab [ Time Frame: Day 1 predose through Week 18 predose ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteWashington D.C.District of Columbia20010-
Research SiteNorfolkVirginia23507-

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By research site
Research Site· Washington D.C., DCResearch Site· Norfolk, VA

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