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
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
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
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 Details
Contition
Generalized Myasthenia Gravis
Age
12+
Phase
PHASE3
Participants Needed
185
Est. Completion Date
Sep 2, 2024
Treatment Type
INTERVENTIONAL
Sponsor
Hoffmann-La Roche
ClinicalTrials.gov NCT Identifier
NCT04963270
Study Number
WN42636
Understanding Clinical Trials
Get answers to your questions about clinical trials.What is clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?