ALXN1210-MG-306

Condition: Generalized myasthenia gravis

Eligibility

Key Inclusion Criteria

  • At least 18 years old
  • Diagnosed with myasthenia gravis at least 6 months prior to the screening visit
  • Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at time of screening

Key Exclusion Criteria

  • Any active or untreated thymoma or history of thymic carcinoma or thymic malignancy
  • History of hypersensitivity to any ingredient contained in ALXN1210
  • History of thymectomy, thymomectomy, or any thymic surgery within 12 months prior to screening

Full Study Name

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis (IRB no. 00000029)

Summary

The purpose of this study is to evaluate whether an investigational drug called ALXN1210 improves skeletal muscle function in patients with generalized myasthenia gravis class II to IV (gMG). Myasthenia gravis is an autoimmune neuromuscular disorder. Researchers aim to learn how ALXN1210 may work in the body, as well as the relationship between the amount of drug taken and its effect on the body (pharmacodynamics).

The study also aims to determine whether ALXN1210 is safe and effective for the treatment of gMG. To this end, researchers will collect information about any side effects of ALXN1210 that may make it difficult for patients to take the drug. Participants will receive either ALXN1210 or placebo (inactive substance).

Phase

Phase III

Principal Investigator

Richard Lewis, MD

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