Generalized Myasthenia Gravis
Conditions
Interventions
Telitacicept (RC18, RC18-L)
Sponsors
Clinical development
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female patient aged >=18 years at screening. Patients have prior confirmed diagnosis of gMG with generalized muscle weakness (typical pattern of weakness meeting the clinical criteria for diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) clinical classification II-IV. Patients have positive antibodies against AChR or MuSK at screening. MG-ADL score >=6 points at screening and baseline with ocular-related score =8 points, and >=4 items score at least 2 points at screening and baseline.
Exclusion criteria
Exclusion criteria: Patients have been diagnosed with any other autoimmune disease which can potentially pose a safety or efficacy confounding risk. Patients having acute or chronic infection. Patients have thymoma within 5 years or have received thymectomy <=6 months prior to screening. Patients with thymoma diagnosed 3-5 years prior to screening may be eligible if thymoma was at a localized stage and definitively treated with complete surgical resection. Patients have a current or history of primary immunodeficiency. Patients have a history of malignancy within the last 5 years. Patients have prior or continuing diagnosis of serious cardiovascular disease, liver, kidney, respiratory system, endocrine or hematologic disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 24 Change from baseline in MG Quality of Life scale (MG-QOL15r) at Week 24 Proportion of patients with a decrease of >=2 points from baseline in MG-ADL score at Week 24 Proportion of patients with a decrease of >=3 points from baseline in QMG score at Week 24 Proportion of patients who achieved minimal symptomatic expression (MSE, defined as having MG-ADL score of 0 or 1) at Week 24 | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Czech Republic, France, Georgia, Italy, Japan, Poland, Spain, United States
Contacts
Public Contactcontact Clinical trial
ICON Clinical Research GK
Outcome results
None listed