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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Janssen Research & Development, LLC
Study ID
NCT05265273
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • Nipocalimab — DRUG
    Nipocalimab will be administered as an IV infusion.

Study Details

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.

Key Dates

Start date
Jul 20, 2022
Status verified
Mar 2026
Primary completion
Jun 26, 2026
Completion
Jul 2, 2029

Study Design

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

Arms

  • Experimental: Nipocalimab
    Participants age 2 to less than (\<) 18 years of age (globally) and 8 to \<18 years of age (for US sites only) will be divided into 2 cohorts as per their age-adolescents 12 to \<18 years and children 2 to \<12 years and will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).

Primary Outcome Measure

Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels [ Time Frame: Up to 3 years ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
Phoenix Children's HospitalPhoenixArizona85016-
Childrens Hospital Los AngelesLos AngelesCalifornia90027-
Lucile Packard Children's Hospital StanfordPalo AltoCalifornia94304-
UCSF Benioff Children's HospitalSan FranciscoCalifornia94158-
Children's Hospital ColoradoAuroraColorado80045-
University of South Florida Morsani Center for Advanced HealthcareTampaFlorida33613-
University of Kansas Medical CenterLawrenceKansas66045-
C.S. Mott Children's HospitalAnn ArborMichigan48109-
Penn State Milton S Hershey Medical CtrHersheyPennsylvania17033-
Childrens Hospital Of PhiladelphiaPhiladelphiaPennsylvania19106-
University of Pittsburgh Medical CenterPittsburghPennsylvania15224-

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Phoenix Children's Hospital· Phoenix, AZChildrens Hospital Los Angeles· Los Angeles, CALucile Packard Children's Hospital Stanford· Palo Alto, CAUCSF Benioff Children's Hospital· San Francisco, CAChildren's Hospital Colorado· Aurora, COUniversity of South Florida Morsani Center for Advanced Healthcare· Tampa, FL

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