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

NCT04963270

TerminatedPhase 3

Sponsor: Hoffmann-La Roche

Conditions: Generalized Myasthenia Gravis

Interventions: Satralizumab, Placebo

Countries: United States, Argentina, Australia, Brazil, Canada, China, Denmark, France

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

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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 (76)
  • Los Angeles, California, United States
  • Orange, California, United States
  • Pasadena, California, United States
  • Washington D.C., District of Columbia, United States
  • Chicago, Illinois, United States
  • O'Fallon, Illinois, United States
  • CABA, Argentina
  • CABA, Argentina
  • Ciudad Autonoma Bs As, Argentina
  • Mendoza, Argentina
  • Rosario, Argentina
  • Concord, New South Wales, Australia
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Campinas, São Paulo, Brazil
  • Santo André, São Paulo, Brazil
  • São Paulo, São Paulo, Brazil
  • Montreal, Quebec, Canada
  • Beijing, China
  • Beijing, China
  • Changchun, China
  • Chengdu, China
  • Guiyang, China
  • Hangzhou, China
  • Jinan, China
  • Shanghai, China
  • Shanghai, China
  • Tianjin, China
  • Wuhan, China
  • Xi'an, China
  • Aarhus N, Denmark
  • + 46 more on CT.gov