A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis
Viela Bio
PI: Dr. Pasnoor
For more information contact Lilli Saavedra; lsaavedra2@kumc.edu

SNAPSHOT
Experimental: Inebilizumab, (AChR-Ab+) MG

• Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the randomized controlled period.
  
• During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183.

Placebo Comparator: Placebo, (AChR-Ab+) MG

• Participants will receive placebo administered IV on Days 1 and 15 and on Day 183 of the randomized controlled period.
  
• During the open-label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183.

Experimental: Inebilizumab, (MuSK-Ab+) MG

• Participants will receive inebilizumab administered IV on Days 1 and 15 of the randomized controlled period.
  
• During the open-label period, participants will receive inebilizumab administered IV on Days 1 and 183

Placebo Comparator: Placebo, (MuSK-Ab+) MG

• Participants will receive placebo administered IV on Days 1 and 15 of the randomized controlled period.
  
• During the open-label period, participants will receive inebilizumab administered IV on Days 1, 15 and 183

​​​​​An Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis

PI: Dr. Statland

​A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis

PI: Dr. Mamatha Pasnoor​

• ​Experimental: efgartigimod IV –
  
  • IPatients receiving efgartigimod IV treatment (Continuous regimen: efgartigimod 10 mg/kg q2w)
    
• Experimental: efgartigimod IV –
  
  •  IIPatients receiving efgartigimod IV treatment (Cyclic regimen: efgartigimod 10 mg/kg q7d for a total of 4 infusions per TP for 2 TPs with a fixed 4-week IP between each TP)

A Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis
University of Kansas Medical Center
​PI: Dr. Mazen Dimachkie

SNAPSHOT
The main aim of this study is to check if people with generalized myasthenia gravis have side effects from 2 doses of TAK-079. Other aims are to learn if TAK-079 improves their clinical condition and lowers their autoantibody levels.

At the first visit, the study doctor will check if each person can take part. For those who can take part, participants will continue with their standard medicines for this condition during the study. Each participant will have a check-up by the study doctor. Then, the participants will have 1 of 3 treatments:

A low dose of TAK-079
A high dose of Tak-079
A placebo. In this study, a placebo looks like TAK-079 but does not have any medicine in it.

Participants will not know which treatment they received, nor will their study doctors. This is to help make sure the results are more reliable.

For each treatment, participants will receive injections just under the skin, once a week for 8 weeks. The study doctors will check for side effects from the study treatments. The study doctors can stop or delay the injections in each participant if needed.

Then, the study doctors will continue to check for side effects for up to 24 weeks after treatment. They will also check the clinical condition of the participants, including their autoantibody levels.

A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants with Refractory Generalized Myasthenia Gravis (gMG)
St. Louis University/SSM Health Cardinal Glennon Children's Hospital
PI: Dr. Jafar Kafaie

SNAPSHOT
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis (QMG) score for disease severity. The study will consist of an up to 4-week Screening Period, 26-week Primary Evaluation Treatment Period, an additional (up to) to 208-week Extension Period, and an 8-week Safety Follow-up Period. Eculizumab will be administered through an intravenous (IV) infusion. Eligibility and inclusion criteria can be found in the clinical trial study record. If interested in this study, please contact the appropriate study coordinator based on location and physician.

Phase 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
MOM-M281-011
PI: Dr. Farmakidis
For more information contact Ali Ciersdorff; aciersdorff@kumc.edu

SNAPSHOT
Experimental: Nipocalimab Double-blind Placebo-controlled Phase:

• Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase.

Placebo Comparator: Placebo Double-blind Placebo-controlled Phase:

• Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.

Open-label Extension (OLE) Phase:

• Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks.
  
• Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase.

Upcoming MG Research Opportunities

Clinical Trials

The MGA maintains communication with representatives from clinical research studies in efforts to keep the public informed about potential trials MG patients can participate in. Take a look at some of the latest studies in our area below or visit the clinical trials database to discover all the research studies conducted around the world.