An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis

Conditions

Myasthenia gravis (MG)

Brief summary

The effect of nipocalimab on total serum IgG in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard-of-care therapy., The safety and tolerability of treatment with nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standardof- care therapy., The pharmacokinetics of nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard of care therapy., All primary PK and IgG endpoints will be summarized descriptively over time for the evaluable population, and for each age cohort (2 to <12, or 12 to <18 years old).

Related papers

No related papers found yet.

Interventions

DRUGJNJ-80202135

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
The effect of nipocalimab on total serum IgG in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard-of-care therapy., The safety and tolerability of treatment with nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standardof- care therapy., The pharmacokinetics of nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard of care therapy., All primary PK and IgG endpoints will be summarized descriptively over time for the evaluable population, and for each age cohort (2 to <12, or 12 to <18 years old).	—

Measure

Time frame

The effect of nipocalimab on total serum IgG in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard-of-care therapy., The safety and tolerability of treatment with nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standardof- care therapy., The pharmacokinetics of nipocalimab in pediatric participants 2 to <18 years of age with gMG who have an insufficient clinical response to ongoing, stable standard of care therapy., All primary PK and IgG endpoints will be summarized descriptively over time for the evaluable population, and for each age cohort (2 to <12, or 12 to <18 years old).

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Countries

Netherlands, Poland

Outcome results

None listed