Auto-immuunziekte Myasthenia Gravis
Conditions
Interventions
The treatment regards: Satralizumab (RO5333787)
This is a humanized anti-interleukin-6 receptor (IL-6R) IgG2 monoclonal
antibody that was constructed by modifying the amino acid sequence of
tociliz
Sponsors
Roche Nederland B.V.
Eligibility
Age
12 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Age >= 12 years at time of signing Informed Consent Form • Confirmed diagnosis of gMG • MGFA class II, III or IV at screening • A total MG-ADL score of >= 5 points at screening with more than 50% of this score attributed to non-ocular items • Ongoing gMG treatment at a stable dose and not exceeding the maximum protocol allowed doses • 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: Exclusion Criteria Related to Myasthenia Gravis (MG): • History of thymic cysts, thymoma, thymic carcinoma or other neoplasm of the thymus as defined by the 2015 WHO classification of tumors of the thymus unless deemed cured by adequate treatment with no evidence of recurrence for >= 5 years before screening • History of thymectomy within 6 months prior to screening • Ocular MG (Myasthenia Gravis Foundation of America [MGFA] Class I) • Myasthenic crisis within the last 3 months prior to screening (MGFA Class V) • Known disease other than gMG that would interfere with the course and conduct of the study Exclusion Criteria Related to Previous or Concomitant Therapy: • Use of IVIg or subcutaneous immunoglobulin (SCIg) within 6 weeks prior to randomization (Day 1) • Use of PE within 8 weeks prior to randomization (Day 1) • Treatment with IL-6 inhibitory therapy (e.g., tocilizumab) at any time, • Treatment with total body irradiation, or bone marrow transplantation at any time • Treatment with B and/or T cell-depleting agents • Treatment with anti-CD20 ,within 6 months prior to screening, unless CD19 counts are within normal range, as assessed by the central laboratory at screening • For patients with prior exposure to anti-CD20 agents, CD19 counts below the normal range, as assessed by the central laboratory at screening, or <6 months since last anti-CD20 treatment till screening • Treatment with C5 complement inhibitors (e.g., eculizumab orravulizumab) within 6 months prior to screening • Treatment with neonatal Fc receptor antagonist, within 6 months prior to screening • Treatment with or anti-B-lymphocyte stimulator monoclonal antibody at any time • Treatment with cyclophosphamide IV within 6 months prior to screening • Treatment with oral cyclophosphamide at any time • Treatment with methotrexate within 8 weeks prior to screening • Treatment with any investigational agent within 24 weeks prior to screening or 5 drug-elimination half-lives of the investigational drug (whichever is longer) • Use of more than one IST as background therapy except for the combination of an oral corticosteroids (OCS) with another permitted IST drug General Safety Exclusion Criteria: • Any surgical procedure (except for minor non-ophthalmic surgeries) within 4 weeks prior to screening • Planned surgical procedure (except minor non-ophthalmic surgeries) during the study • Evidence of progressive multifocal leukoencephalopathy • Evidence of serious uncontrolled concomitant diseases that may preclude patient participation • Congenital or acquired immunodeficiency, including human immunodeficiency virus (HIV) infection • Active or presence of recurrent bacterial, viral, fungal, mycobacterial infection, or other infection, excluding fungal infection of nail beds or dental caries • Infection requiring hospitalization or treatment with IV anti-infective agents within 4 weeks prior to baseline visit or oral anti-infective agents within 2 weeks prior to baseline visit • Positive screening tests for hepatitis B and C • History of drug or alcohol abuse within 1 year prior to baseline • History of diverticulitis or concurrent severe gastrointestinal (GI) disorders that, in the investigator*s opinion, may lead to increased risk of complications such as GI perforation<br
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of satralizumab versus placebo on function in daily life in the AChR + population. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objectives in this study are focused on: efficacy, safety, pharmacokinetics, and pharmacodynamics. for a detailed overview I would like to refer to the section 'objectives and endpoints', section 2. of the WN42636 (LUMINESENCE) Protocol | — |
Countries
Netherlands
Outcome results
None listed