At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of generalized myasthenia gravis (gMG) meeting MGFA Clinical Classification Class II a/b, III a/b, or IVa/b at screening
- ✓MG-ADL score ≥6 at screening and baseline
- ✓Sufficient venous access for IV infusion and blood sampling
- ✓For SC substudy: reasonable abdominal skin area for subcutaneous administration
- ✕Immunodeficiency syndrome not related to gMG treatment, or family history of congenital/hereditary immunodeficiency (unless confirmed absent)
- ✕MGFA Class I disease, MG crisis (Class V), or fixed/burnt-out MG
- ✕History of MG crisis within 1 month of screening
- ✕Thymectomy within 12 months prior to screening or planned during study
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
NCT04951622Phase 3RecruitingUpdate OverdueUpdated 3mo ago · Completion was 31mo agoPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
In Brief
A Phase 3 clinical trial evaluating Nipocalimab, Placebo, and 1 other intervention for Myasthenia Gravis. Currently recruiting, targeting 199 participants across 112 sites in 17 countries.
Signals
Detailed Summary
The purpose of this study is to evaluate the efficacy and safety of nipocalimab compared to placebo in participants with generalized myasthenia gravis (gMG). The purpose of the subcutaneous substudy is to evaluate how well it works in the body (pharmacodynamic \[PD\]) when given as an injection under the skin (subcutaneous) compared to when given through a vein (intravenous) in participants with gMG.
Study Details
Timeline
Interventions
Nipocalimab will be administered as an IV infusion.
Matching placebo will be administered as an IV infusion.
Nipocalimab will be administered subcutaneously.