Myasthenia Gravis, Generalized
Conditions
Brief 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).
Interventions
DRUGPovetacicept
Solution for Subcutaneous Injection.
DRUGPlacebo
Solution for Subcutaneous Injection.
Sponsors
Vertex Pharmaceuticals Incorporated
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Age greater than or equal to (\>=) 18 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Total Immunoglobulin G (IgG) | Baseline and At Week 12 |
| Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) | From Baseline Up to Week 116 |
Countries
Australia, Poland, Turkey (Türkiye), United Kingdom, United States
Contacts
CONTACTMedical Information
Outcome results
None listed