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Clinical Trials

​​​​​Clinical Trials Available at the University of Kansas Medical Center
Below are brief summaries of the 3 enrolling studies.  For more information please contact  Samantha Colgan, 913-945-9938, scolgan@kumc.edu.


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.