Clinical trial · Interventional
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor decided to halt development of satralizumab in generalized myasthenia gravis and discontinued further dosing with the study drug (while the OLE period was ongoing) upon reviewing the primary results (DB period).
Summary
Brief summary (as posted)
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Generalized Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Satralizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Satralizumab
- 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.
- interventionNames
- Drug: Satralizumab
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDHabib AA, Zhao C, Aban I, Franca MC Jr, Jose JG, Zu Horste GM, Klimiec-Moskal E, Pulley MT, Tavolini D, Krumova P, Lennon-Chrimes S, Smith J, Thanei GA, Blondeau K, Vodopivec I, Wolfe GI, Murai H. Safety and efficacy of satralizumab in patients with generalised myasthenia gravis (LUMINESCE): a randomised, double-blind, multicentre, placebo-controlled phase 3 trial. Lancet Neurol. 2025 Feb;24(2):117-127. doi: 10.1016/S1474-4422(24)00514-3. PMID 39862880