for people ages 12 years and up (full criteria)
at Orange, California and other locations
study started
completion around



This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis


Generalized Myasthenia Gravis, Myasthenia Gravis, Muscle Weakness, Satralizumab


You can join if…

Open to people ages 12 years and up

  • Signed Informed Consent Form
  • For adolescent patients: Informed Consent Form for study participation signed by the parents or a legal guardian, and patient assent obtained, as per local requirements
  • Ability to comply with the study protocol procedures
  • Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
  • A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
  • MGFA severity Class II-IV
  • Ongoing gMG treatment at a stable dose
  • For female patients of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for at least 3 months after the final dose of satralizumab.

You CAN'T join if...

  • History of thymectomy within 12 months prior to screening
  • Ocular MG (MGFA Class I) and myasthenic crisis (MGFA Class V) within the last 3 months prior to screening
  • Known disease other than gMG that would interfere with the course and conduct of the study
  • Positive screening tests for hepatitis B virus (HBV) and hepatitis C virus (HCV)
  • Evidence of latent or active tuberculosis (excluding patients receiving chemoprophylaxis for latent tuberculosis infection)
  • Receipt of live or live attenuated vaccine within 6 weeks prior to baseline
  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the last dose


  • University of California Irvine - Manchester Pavilion in progress, not accepting new patients
    Orange California 92868 United States
  • Keck School of Medicine of USC in progress, not accepting new patients
    Los Angeles California 90033 United States
  • Rigshospitalet; Klinik for Nerve- og Muskelsygdomme accepting new patients
    København Ø 2100 Denmark
  • Krasnoyarsk State Medical Academy accepting new patients
    Krasnoyarsk Krasnojarsk 660049 Russian Federation
  • National Center of Social Significant Disease withdrawn
    Sankt-peterburg Leningrad 197110 Russian Federation
  • Research Center of Neurology; Neurology Department #5 withdrawn
    Moskva Moskovskaja Oblast 125367 Russian Federation
  • Leningrad Regional Clinical Hospital withdrawn
    St Petersburg Sankt Petersburg 194291 Russian Federation
  • Novosibirsk State Regional Clinical Hospital in progress, not accepting new patients
    Novosibirsk 630087 Russian Federation
  • Samara Regional Clinical Hospital named after V.D. Seredavina withdrawn
    Samara 443095 Russian Federation


accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
Hoffmann-La Roche
Phase 3 Myasthenia Gravis Research Study
Study Type
Expecting 185 study participants
Last Updated