For Healthcare Professionals

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

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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).
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Who can take part

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

INCLUSION 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

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
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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


Contition

Generalized Myasthenia Gravis

Age (in years)

12+

Phase

Phase 3

Participants needed

185

Est. Completion Date

Dec 11, 2027

Treatment type

Interventional


Sponsor

Hoffmann-La Roche

ClinicalTrials.gov identifier

NCT04963270

Study number

WN42636

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