Generalized Myasthenia Gravis
Conditions
Interventions
dosage: 10mg/kg (capped at 1200 mg)
control material(s)
Generic name etc : ARGX-113 placebo
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Inv
dosage: 10mg/kg (capped at 1200 mg)
Sponsors
argenx
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. 2. Male or female patients aged >= 20 years. 3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for diagnosis of MG as defined by the MGFA class II, III, IVa and IVb. Other, more specific inclusion criteria are defined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating women, and those intending to become pregnant during the trial or within 90 days after the last dosing. 2. Male patients who are sexually active and do not intend to use effective methods of contraception during the trial or within 90 days after the last dosing or male patients who plan to donate sperm during the trial or within 90 days after the last dosing. 3. MGFA Class I and V patients. 4. Patients with worsening muscle weakness secondary to concurrent infections or medications. 5. Patients with known seropositivity or who test positive for an active viral infection at Screening with: oHepatitis B Virus (HBV) (except patients who are seropositive because of HBV vaccination) oHepatitis C Virus (HCV) oHuman Immunodeficiency Virus (HIV) 6. Other, more specific exclusion criteria are further defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Efficacy of ARGX-113 as assessed by the percentage of "Myasthenia Gravis Activities of Daily Living (MG-ADL) responders" in the acetylcholine receptor (AChR)-antibody (Ab) seropositive population. | — |
Secondary
| Measure | Time frame |
|---|---|
| safety efficacy 1. Efficacy of ARGX-113 as assessed by the percentage of "QMG responders" in the AChR-Ab seropositive population. 2. Efficacy of ARGX-113 as assessed by the percentage of "MG-ADL responders" in the overall population (AChR-Ab seropositive and AChRAb seronegative patients). 3. Efficacy of ARGX-113 as assessed by the percentage of time that patients show a "clinically meaningful improvement" in total MG-ADL score during the trial in the AChR-Ab seropositive population. 4. Duration of response 5. Onset of efficacy of ARGX-113 as assessed by the percentage of "early MG-ADL responders" in the AChR-Ab seropositive population. 6. Safety and tolerability of ARGX-113 in the overall population and in subgroups. | — |
Countries
Europe, Japan, North America
Outcome results
None listed