Back to search results

Nipocalimab for Children with Generalized Myasthenia Gravis

This study is testing a drug called nipocalimab in children aged 2 to less than 18 years old who have generalized myasthenia gravis (gMG), a condition causing muscle weakness. The study aims to see how nipocalimab affects levels of a protein called immunoglobulin G (IgG) in the blood, and to check its safety and how the body processes it. You might be able to join if you are between 2 and 17 years old (or 8 to 17 in the US) with gMG, and your current treatment isn't working well enough. A key part of joining is having a positive test for acetylcholine receptor antibodies. The study is also looking at how many participants experience infections or serious side effects. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 12 participants. It is testing the drug nipocalimab given as an intravenous (IV) infusion.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years to monitor changes in IgG levels and the occurrence of adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05265273

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

Recruiting
PHASE2Ages 2–17InterventionalTreatment
Janssen Research & Development, LLC
~12 participants
Updated 2026-07-31 on ClinicalTrials.gov
What's tested:Nipocalimab

At a glance

Recruiting sites
15 of 19 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from Baseline in Total Serum Immunoglobulin-G (IgG) Levels
Measured over Up to 3 years
+13 more outcomes measured

Conditions

Myasthenia Gravis

Explore related trials

Myasthenia GravisAcetylcholine ReceptorMuscle, Skeletal Receptor Tyrosine-Protein Kinase

Where it's being run

19 sites across 10 states
Japan6
California3
Pennsylvania3
Arizona1
Colorado1
Florida1
Kansas1
Michigan1

Study leadership

  • Janssen Research & Development, LLC Clinical Trial · STUDY_DIRECTOR · Janssen Research & Development, LLC

Who to contact

Study Contact
[email protected]
844-434-4210
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Age: For US sites only: 8 to \< 18 years
Diagnosis of myasthenia gravis (MG) with generalized muscle weakness meeting the clinical criteria for generalized myasthenia gravis (gMG) as defined by the Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class IIa/b, IIIa/b, or IVa/b at screening
Has a positive serologic test for acetylcholine receptor (anti-AChR) antibodies or muscle-specific tyrosine kinase (anti-MuSK) antibodies at screening
A participant using herbal, naturopathic, traditional Chinese remedies, ayurvedic or nutritional supplements, or medical marijuana (with a doctor's prescription) is eligible if the use of these medications is acceptable to the Investigator. These remedies must remain at a stable dose and regimen throughout the study
Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
Participants should have a body weight and body mass index between 5th and 95th percentile for age and sex. Obese participants greater than 95th percentile and underweight participants below 5th percentile may participate following medical clearance
A female of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at Screening and a negative urine pregnancy test at Day 1 prior to administration of study intervention

Exclusion

Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/ autoimmune hepatitis/ cirrhosis/ and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular (including congenital heart diseases), psychiatric, neurological musculoskeletal disorder, any other medical disorder(s) (example, diabetes mellitus), risk factors for thrombosis events (example, a history of venous thromboembolism \[VTE\] or antiphospholipid syndrome, or a personal or family history of heritable coagulation disorder such as factor V leiden, protein S or protein C deficiency, atrial fibrillation/flutter, major orthopedic surgery or significant trauma that may increase the risk of VTE, is expected to be immobilized for prolonged periods of time), or has clinically significant abnormalities in screening laboratory, that might interfere with participant's full participation in the study, and/ or might jeopardize the safety of the participant or the validity of the study results
Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her generalized myasthenia gravis (gMG), or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the Active treatment Phase of the study
Has shown a previous severe immediate hypersensitivity reaction, such as anaphylaxis to therapeutic proteins (example, monoclonal antibodies)
Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening

What this trial measures

  • Change from Baseline in Total Serum Immunoglobulin-G (IgG) LevelsUp to 3 years

    Change from baseline in total serum IgG levels were reported.

  • Number of Participants with Infectious Adverse Events (AEs)Up to 3 years

    Number of participants with infectious AEs will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.

  • Number of Participants with Serious AEs (SAEs)Up to 3 years

    Number of participants with SAEs will be reported. A SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important to prevent one of the outcomes listed above.

  • Number of Participants with Adverse Events of Special Interests (AESIs)Up to 3 years

    Number of participants with AESIs will be reported. Treatment-emergent AEs associated with the following situations are considered an AESI: a) infections that are severe or require intravenous (IV) anti-infective or operative/invasive intervention; b) hypoalbuminemia with albumin less than (\<)20 grams per liter (g/L) \[\<\] 2.0 grams per deciliter \[g/dL\]) c) opportunistic infections and d) Serious and non-serious deep-vein thrombosis (DVT) and/or pulmonary embolism (PE). Any AE occurring at or after the initial administration of study intervention through end of study is treatment emergent.

  • Number of Participants with Abnormalities in Clinical Laboratory TestsUp to 3 years

    Number of participants with abnormalities in clinical laboratory tests (including chemistry, hematology, coagulation, and urinalysis) will be reported.

  • Number of Participants with Abnormalities in Vital SignsUp to 3 years

    Number of participants with abnormalities in vital signs including sitting pulse/heart rate, sitting systolic and diastolic blood pressure, and oral temperature (degrees Celsius) will be reported.

  • Number of Participants with Abnormalities in Physical ExaminationUp to 3 years

    Number of participants with abnormalities in physical examinations including height, weight, assessments of the skin, head, eyes, ears, nose, throat, neck, thyroid, lungs, heart, abdomen, lymph nodes and extremities will be reported.

  • Serum Concentration of Nipocalimab over TimeUp to 3 years

    Serum samples will be analyzed to determine concentrations of nipocalimab using a validated, specific, and sensitive immunoassay method.

  • Clearance (CL) of NipocalimabUp to 3 years

    CL is defined as the volume of serum from which nipocalimab is completely removed per unit time.

  • Volume of Distribution (V) of NipocalimabUp to 3 years

    V is defined as the representation of nipocalimab's propensity to either remain in the serum or redistribute to other tissue compartments.

  • Half-life (t1/2) of NipocalimabUp to 3 years

    t1/2 is defined as the time it takes for nipocalimab's active substance in the body to reduce by half.

  • Steady-state Peak Concentration (Cpeak,ss) of NipocalimabUp to 3 years

    Cpeak,ss is defined as the peak serum concentration of nipocalimab at steady state.

  • Steady-state Trough concentration (Ctrough,ss) of NipocalimabUp to 3 years

    Ctrough,ss will be reported. It is defined as the observed serum concentration of nipocalimab just prior to the beginning of a dosing interval at steady state.

  • Steady-state Area Under the Curve (AUCss) of NipocalimabUp to 3 years

    AUCss is defined as the area under the curve for nipocalimab at steady state.