Summary

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

Description

Summary

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

Keywords

Generalized Myasthenia Gravis Myasthenia Gravis Muscle Weakness Satralizumab

Eligibility

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

Locations

  • University of California Irvine - Manchester Pavilion
    Orange California 92868 United States
  • Keck School of Medicine of USC
    Los Angeles California 90033 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT04963270
Phase
Phase 3
Study Type
Interventional
Last Updated