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A Study of Nipocalimab for Generalized Myasthenia Gravis

This study is testing a drug called nipocalimab to see how well it works and if it's safe for adults with generalized myasthenia gravis (gMG). Researchers want to compare nipocalimab to a placebo (an inactive substance) to understand its effects. They are also looking at two ways to give nipocalimab: through a vein (intravenous infusion) and as an injection under the skin (subcutaneous). To join, you must be an adult (18 years or older) with a confirmed diagnosis of gMG, specifically classified as MGFA Class II a/b, III a/b, or IVa/b, and have an MG-ADL score of 6 or higher. The main way they will measure success is by looking at changes in your Myasthenia Gravis - Activities of Daily Living (MG-ADL) scores over 22 to 24 weeks.

Study design
This is an interventional study with a planned enrollment of 199 participants. It includes a double-blind phase, meaning neither you nor your doctor will know if you are receiving nipocalimab or placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint measures changes up to Week 24. Some sub-studies track changes up to Week 8 (Day 57).

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

NCT04951622

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis

Recruiting
PHASE3Ages 18+InterventionalTreatment
Janssen Research & Development, LLC
~199 participants
Updated 2026-07-27 on ClinicalTrials.gov
What's tested:NipocalimabPlaceboNipocalimab SC-LIV

At a glance

Recruiting sites
68 of 112 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24
Measured over Baseline, Weeks 22, 23, and 24
+2 more outcomes measured

Conditions

Myasthenia Gravis

Explore related trials

Myasthenia Gravis

Where it's being run

112 sites across 32 states
Japan16
China14
Spain8
Italy7
Germany6
Belgium5
France5
Poland5

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

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 II a/b, III a/b, or IVa/b at screening
Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of greater than or equal to (\>=) 6 at screening and baseline
Has sufficient venous access to allow drug administration by infusion and blood sampling as per the protocol
A woman 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
A male participant must agree not to donate sperm for the purpose of reproduction during the study and for a minimum 90 days after receiving the last administration of study intervention
For the SC Substudy (Cohort 1 and Cohort 2): Has reasonable abdominal skin area for SC administration
For the SC Substudy (Cohort 1 and Cohort 2): Participants must be willing to comply with maintaining their stable dose of corticosteroids and/or immunosuppressants for the initial 8 weeks of the SC substudy, that is, through the SC Week 8 visit

Exclusion

Has any confirmed or suspected clinical immunodeficiency syndrome not related to treatment of his/her gMG, or has a family history of congenital or hereditary immunodeficiency unless confirmed absent in the participant
Has MGFA Class I disease or presence of MG crisis (MGFA Class V) at screening, history of MG crisis within 1 month of screening, or fixed weakness (and/or 'burnt out' MG)
Has had a thymectomy within 12 months prior to screening, or thymectomy is planned during the study
Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
Has experienced myocardial infarction, unstable ischemic heart disease, or stroke within 12 weeks of screening
For the SC Substudy (Cohort 1): Participants who have undergone a recent tapering of their concomitant MG medication in the OLE
For the SC Substudy (Cohort 1): Participants deteriorating during the OLE in the month prior to SC Dose 1 of the SC substudy such that they meet the criteria for clinical deterioration
For the SC Substudy (Cohort 2): History of an unprovoked pulmonary embolism within 1 year prior to screening or history of recurrent deep vein thrombosis (DVT)

What this trial measures

  • Double-blind (DB) Phase: Average Change From Baseline in Myasthenia Gravis - Activities of Daily Living (MG-ADL) Total Score Over Weeks 22, 23, and 24Baseline, Weeks 22, 23, and 24

    Average change from baseline over multiple timepoints (Weeks 22, 23, and 24) was reported in this outcome measure. The MG-ADL provided a rapid assessment of the participant's MG symptom severity of eight functions (talking, chewing, swallowing, breathing, impairment of ability to brush teeth or comb hair, impairment of ability to arise from a chair, double vision, eyelid droop) rated on a 4-point scale ranging from 0 (normal) to 3 (severe). MG-ADL total score was sum of 8 individual items, which ranging from 0 to 24. A higher score indicated greater symptom severity. Baseline was defined as the average of the screening and Day 1 total scores.

  • Sub Study: Percent Change in Anti-AChR Autoantibody Titer From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)
  • Sub Study: Percent Change in Total IgG Levels From Pre-first Nipocalimab Dose on Day 1 up to Week 8 (Day 57)From pre-first nipocalimab dose on Day 1 up to Week 8 (Day 57)