Clinical Trials

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

ALEXION

Description
A 26-week, Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Adult Patients with Generalized Myasthenia Gravis. There are two treatment arms: experimental Ravulizumab and placebo. After week 26 patients will roll into the open label extension where all patients receive Ravulizumab.​

Inclusion Criteria

• ​Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
  
• Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
  
• MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
  
• Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).
  
• 18 years and older.

Exclusion Criteria

• ​​Any active or untreated thymoma.
  
• History of thymectomy within the 12 months prior to screening.
  
• History of N meningitidis infection.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
• Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
  

RA PHARMA

Description

A 12-week, Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis. There are two treatment arms: experimental Zilucoplan and placebo. After week 12 patients will roll into the open label extension where all patients receive Zilucoplan. 

Inclusion Criteria

• Diagnosis of gMG [Myasthenia Gravis Foundation of America Class II-IV] at Screening.
  
• Positive serology for acetylcholine receptor (AChR) autoantibodies.
  
• MG-ADL Score of ≥ 6 at Screening and Baseline.
  
• QMG score ≥ 12 at Screening and Baseline.
  
• No change in corticosteroid dose for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period.
  
• No change in immunosuppressive therapy, including dose, for at least 30 days prior to Baseline or anticipated to occur during the 12-week Treatment Period.
  
• 18 years and older.

​

Exclusion Criteria

• Thymectomy within 12 months prior to Baseline or scheduled to occur during the 12-week Treatment Period.
  
• History of meningococcal disease.
  
• Current or recent systemic infection within 2 weeks prior to Baseline or injection requiring intravenous (IV) antibiotics within 4 weeks prior to Baseline.

UCB MG0003

Description
A 36-week, Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. There are three treatment arms: two experimental Rozanolixizumab arms and one placebo. After week 36, patients will roll into an open label extension where patient will receive Rozanolixizumab.

Inclusion Criteria

• Study participant must be ≥18 years of age.
  
• Study participant has documented diagnosis of generalized myasthenia gravis (gMG) at Visit 1, based on study participant's history and supported by previous evaluations.
  
• Study participant has a confirmed positive record of autoantibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) prior to Visit 1.
  
• Study participant has Myasthenia Gravis Foundation of America (MGFA) Class II to IVa at Visit 1.
  
• Study participant with a myasthenia gravis-activities of daily living (MG-ADL) score of at least 3 AND a quantitative myasthenia gravis (QMG) score of at least 11 at Visit 1 and at Baseline.

Exclusion Criteria

• Study participant has a clinically relevant active infection (eg, sepsis, pneumonia, or abscess) in the opinion of the Investigator, or had a serious infection (resulting in hospitalization or requiring parenteral antibiotic treatment) within 6 weeks prior to the first dose of investigational medicinal product (IMP).
  
• Study participant has experienced hypersensitivity reaction after exposure to other anti-neonatal Fc receptor (FcRn) drugs.    
  
• Use of rituximab or other “mabs” within 6 months of screening.
  
• History of thymectomy within 6 months of screening .
  
• Study participant with severe (defined as Grade 3 on the MG-ADL scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis a Visit 1.

Clinical Trials