For Healthcare Professionals

A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis


About the study

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

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

  1. Signed Informed Consent Form
  2. 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
  3. Ability to comply with the study protocol procedures
  4. Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
  5. A total MG-ADL score of ≥ 5 points at screening with more than 50% of this score attributed to non-ocular items
  6. MGFA severity Class II-IV
  7. Ongoing gMG treatment at a stable dose
  8. 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.


Exclusion Criteria:

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

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


Generalized Myasthenia Gravis

Age (in years)



Phase 3

Participants needed


Est. Completion Date

Dec 11, 2027

Treatment type



Hoffmann-La Roche identifier


Study number


Understanding Clinical Trials

Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?


Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.