A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis
Condition(s) studied
Investigational drug(s) / intervention(s)
Nipocalimab: Nipocalimab will be administered as an IV infusion.
Placebo: Matching placebo will be administered as an IV infusion.
Nipocalimab SC-LIV: Nipocalimab will be administered subcutaneously.
Study 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.
Eligibility
Primary outcome measure(s)
- 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 — Baseline, 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)
Trial sites (112)
| Facility | City | Region | Status |
|---|---|---|---|
| Neuromuscular Research Center and Clinic | Paradise Valley | Arizona | Recruiting |
| HonorHealth Neurology | Scottsdale | Arizona | Completed |
| University of Southern California | Los Angeles | California | Completed |
| Stanford University | Palo Alto | California | Completed |
| Care Access Research | Pasadena | California | Recruiting |
| University of Colorado Anschutz Medical Campus | Aurora | Colorado | Recruiting |
| Yale New Haven Hospital | New Haven | Connecticut | Recruiting |
| FM Clinical Research, LLC South Florida Neurology Associates, P. A. | Boca Raton | Florida | Recruiting |
| University of Florida Health Jacksonville | Jacksonville | Florida | Completed |
| Medsol Clinical Research Center Inc | Port Charlotte | Florida | Recruiting |
| University of South Florida | Tampa | Florida | Recruiting |
| Augusta University | Augusta | Georgia | Completed |
| University of Kansas Medical Center | Kansas City | Kansas | Recruiting |
| St. Elizabeth Medical Center | Boston | Massachusetts | Completed |
| Lahey Hospital & Medical Center | Burlington | Massachusetts | Completed |
| Washington University School Of Medicine | St Louis | Missouri | Completed |
| Duke University School of Medicine | Durham | North Carolina | Recruiting |
| University of Cincinnati | Cincinnati | Ohio | Completed |
| Cleveland Clinic | Cleveland | Ohio | Recruiting |
| The Ohio State University | Columbus | Ohio | Completed |
| Medical University of South Carolina | Charleston | South Carolina | Recruiting |
| Wesley Neurology | Cordova | Tennessee | Completed |
| UT Southwestern Medical Center | Dallas | Texas | Completed |
| University of Vermont | Burlington | Vermont | Completed |
| Melbourne Neurology Group | North Melbourne | Australia | Completed |
| Gold Coast University Hospital | Southport | Australia | Recruiting |
| ULB Hôpital Erasme | Anderlecht | Belgium | Recruiting |
| AZ Sint Jan Brugge Oostende AV | Bruges | Belgium | Recruiting |
| Cliniques Universitaires Saint Luc | Brussels | Belgium | Recruiting |
| AZ Sint-Lucas | Ghent | Belgium | Recruiting |
| University Hospitals Leuven | Leuven | Belgium | Recruiting |
| The Ottawa Hospital Research Institute | Ottawa | Ontario | Recruiting |
| Toronto General Hospital | Toronto | Ontario | Recruiting |
| McGill University | Montreal | Quebec | Completed |
| Beijing Tiantan Hospital, Capital Medical University | Beijing | China | Recruiting |
| Xuanwu Hospital ,Capital Medical University | Beijing | China | Completed |
| Beijing Hospital | Beijing | China | Recruiting |
| The First Bethune Hospital of Jilin University | Changchun | China | Recruiting |
| Xiangya Hospital Central South University | Changsha | China | Recruiting |
| West China Hospital of Sichuan University | Chengdu | China | Completed |
+ 72 more sites — see the full list on the official registry below.
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04951622 on ClinicalTrials.gov ↗ ← All trials in Spain