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NCT05265273 · ClinicalTrials.gov record · last posted 2026-07-31

A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis

StatusRecruiting
PhasePhase 2/3
Started2022-07-20
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The purpose of this study is to determine the effect of nipocalimab on total serum immunoglobulin G (IgG) in pediatric participants 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for Unites Stated (US) sites only), the safety and tolerability of treatment with nipocalimab in children and adolescents and to evaluate the pharmacokinetics (PK) of nipocalimab in children and adolescents with generalized myasthenia gravis (gMG) who have an insufficient clinical response to ongoing, stable standard-of-care therapy.

Protocol amendment history 1 change detected by DataLookout

2026-08-01
Primary completion pushed: 2026-06-26 → 2027-06-30
Trial Details
NCT Number NCT05265273
Lead Sponsor Janssen Research & Development, LLC
Conditions Myasthenia Gravis
Enrollment 12 participants
Start Date 2022-07-20
Primary Completion 2027-06-30 (estimated)
Study Completion 2029-07-02 (estimated)
Updated on ClinicalTrials.gov 2026-07-31