A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With a Long-term Extension of Povetacicept in Adults With Generalized Myasthenia Gravis
Vertex Pharmaceuticals Incorporated
Summary
The purpose of this study is to evaluate the pharmacodynamic (PD) effect, safety, and tolerability of Povetacicept in participants with generalized myasthenia gravis (gMG).
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Age 18-80 years * Diagnosis of generalized myasthenia gravis with generalized muscle weakness and fitting MGFA clinical classification II-IV * Additional inclusion criteria are defined in the protocol Key Exclusion Criteria: * History of thymic surgery within 6 months of screening * History of malignancy within the last 5 years * Additional exclusion criteria are defined in the protocol Other protocol defined Inclusion/Exclusion criteria will apply.
Interventions
- DrugPovetacicept
Solution for Subcutaneous Injection.
- DrugPlacebo
Solution for Subcutaneous Injection.
Locations (6)
- Neurology OfficesBoca Raton, Florida
- Homestead Associates in ResearchHomestead, Florida
- Quantix ResearchMiami, Florida
- Hawaii Pacific NeuroscienceHonolulu, Hawaii
- Las Vegas Neurology CenterLas Vegas, Nevada
- Clinical Trials of South Carolina - NeurologyCharleston, South Carolina