University of Kansas Medical Center
Below are brief summaries of the 3 enrolling studies.  For more information please contact  Samantha Colgan at (913-)945-9938 or scolgan@kumc.edu.

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 below or visit the clinical trials database to discover all the research studies conducted around the world.

Saint Louis University

Dr. Jafar Kafaie - ECU-MG-303 (Pediatric Patients) - Coordinator: Jennifer Light

This clinical trial is specifically for pediatric seropositive gMG patients (ECU-MG-303). This is an open-labeled, multicenter study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of ECULIZUMAB in PEDIATRIC PATIENTS with generalized Myasthenia Gravis. Dr. Jafar Kafaie of SLU is the PI. Please contact Jennifer Light at jennifer.light@health.slu.edu if interested.

Clinical Trials

MGChampion Study/Alexion 306

This study is looking at an experimental drug called Ravulizumab, which is given through an IV infusion.  This is a randomized control trial in which patients receive either the investigational drug or placebo every 8 weeks for 26 weeks.  Once treatment starts the visits are about every 8 weeks and there are some remote options they’ve made available to patients once on treatment.   After the first 26 weeks are complete participants will then roll over into an open-label extension where all the patients will be able to receive Ravulizumab. Contact June Smith directly at smith.june@wustl.edu if interested.

Study Website- https://mgchampion.com/
Clinicaltrials.gov- https://clinicaltrials.gov/ct2/show/NCT03920293

 

MycaringMG/UCB MG0003

This study is looking at an experimental drug called Rozanolixizumab, which is given through a subcutaneous infusion.  This is also a randomized control trial in which the patients receive either the investigational drug or placebo.  The infusions are given weekly.  This study is 18 weeks with 6 infusions than an observation period.  Once completed the participants are given the option to enroll in a separate open-label extension study which would include infusions with the investigational drug.  Contact June Smith directly at smith.june@wustl.edu if interested.

Study Website- https://www.mycaringstudy.com/
Clinicaltrials.gov https://clinicaltrials.gov/ct2/show/NCT03971422

Dr. Dimachkie – UCB Biopharma MG0003- Coordinator: Ali Ciersdorff  

• 18 weeks; 6 weekly treatment visits after initial baseline treatment, followed by an observation period
  
• 2/3 chance of receiving drug, 1/3 chance of receiving placebo
  
• Subcutaneous injection
  
• A 60-week Open-label is offered after the 18-week trial is complete – In the open-label all participants receive drug
  
• Payment: $84 – baseline, visit 4, 5, 6, 8, and 9; completion of entire study participants will receive up to $504
  
• Travel reimbursement is $53 per visit up $742 (this includes gas, food, hotel, etc.)

Eligibility Criteria: 

• Positive serology for AChR or MUSK autoantibodies (Sero+ MG)
  
• No active or untreated thymoma, and no thymectomy within the past 6 months
  
• No use of the following within the time period specified below:
  
  • IV immunoglobulin within 4 weeks of Baseline
    
  • Use of plasma exchange within 4 weeks of Baseline
    
  • Use of rituximab or any other “Mabs” within 6 months of screening

Dr. Dimachkie – Alexion- Coordinator: Katie Jennens 

• 26 Weeks – 9 study visits
  
• 50% chance receiving drug, 50% chance of receiving placebo
  
• 5 weekly visits, come back a month after the 5th visit for the 6th visit, visits 7-10 are every 2 weeks, visits 11 and 12 are monthly
  
• Infusion at study visit 2, 4, 8, and 11
  
• After the 26 weeks, patients will enroll in “Open-Label”, meaning all patients will receive drug
  
• Up to $50 reimbursement

Eligibility Criteria: 

• Positive serology for AChR autoantibodies (Sero+ MG)
  
• No active or untreated thymoma, and no thymectomy within past 12 months
  
• No use of the following within the time period specified below:
  
  • IV immunoglobulin within 4 weeks of randomization
    
  • Use of plasma exchange within 4 weeks of randomization
    
  • Use of rituximab within 6 months of screening

Dr. Farmakidis – Ra Pharma – Coordinator: Samantha Colgan

• 16 weeks – 7 study visits (including screening)
  
• 50% chance receiving drug, 50% chance of receiving placebo
  
• Self-administered daily injections
  
• After screening, 3 weekly visits, 4th visit is 2 weeks after visit 3, 5th visit is one month after visit 4, 6th visit is one month after visit 5
  
• After the 12 weeks, patients will enroll in “Open-Label”, meaning all patients will receive drug
  
• $45 per visit, mileage reimbursement depending on distance

Eligibility Criteria: 

• Positive serology for AChR autoantibodies (Sero+ MG)
  
• No change in corticosteroid dose for at least 30 days prior to treatment
  
• No change in immunosuppressive therapy for at least 30 days prior to treatment
  
• No Thymectomy within past 12 months

Clinical Trials

Washington University School of Medicine in St. Louis

A PDF version of the clinical trials list can be accessed here.