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

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Satralizumab; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04963270

WN42636

Details and patient eligibility

About

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

Enrollment: 185 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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185 participants in 2 patient groups, including a placebo group

Satralizumab

Experimental group

Description:

Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.

Treatment:

Drug: Satralizumab

Placebo

Placebo Comparator group

Description:

Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter

Treatment:

Other: Placebo