A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
Stopped early · Phase 3 · Has a placebo group
Conditions studied: Generalized Myasthenia Gravis
In brief
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
Key facts
- Study ID
- NCT04963270
- Run by
- Hoffmann-La Roche
- People needed
- 188
- Starts
- 2021-10-19
- Expected to finish
- 2024-09-02
- Last updated by the study team
- 2025-02-28
Who can join
Age: 12 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of California Irvine - Manchester Pavilion — Orange, California, United States
- SC3 Research Group, Inc — Pasadena, California, United States
- Medical Faculty Associates Inc. — Washington D.C., District of Columbia, United States
- University of Chicago Hospital — Chicago, Illinois, United States
- Prairie Education and Research — O'Fallon, Illinois, United States
- Hospital Italiano — CABA, Argentina
- Hospital Ramos Mejía — CABA, Argentina
- Hospital Britanico — Ciudad Autonoma Bs As, Argentina
- Fundación Scherbovsky — Mendoza, Argentina
- INECO Neurociencias Orono — Rosario, Argentina
- Concord Repatriation General Hospital — Concord, New South Wales, Australia
- Hospital Sao Lucas - PUCRS — Porto Alegre, Rio Grande do Sul, Brazil
- Hospital das Clinicas - UNICAMP — Campinas, São Paulo, Brazil
- Faculdade de Medicina do ABC - FMABC — Santo André, São Paulo, Brazil
- Hospital Sao Paulo — São Paulo, São Paulo, Brazil
- MUCH - Montreal Neurological Institute & Hospital — Montreal, Quebec, Canada
- Beijing Tongren Hospital — Beijing, China
- Beijing Tiantan Hospital,Capital Medical University — Beijing, China
- The First Hospital of Jilin University — Changchun, China
- West China Hospital - Sichuan University — Chengdu, China
- The Affiliated Hospital of Guizhou Medical University — Guiyang, China
- Sir Run Run Shaw Hospital — Hangzhou, China
- The First Affiliated Hospital Of Shandong First Medical University — Jinan, China
- Huashan Hospital, Fudan University — Shanghai, China
- Keck School of Medicine of USC — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.