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

• Status: Not yet recruiting
• Trial end date: 2025-09-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche

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