A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Purpose
The main purpose of this study is to measure how well adults with new-onset gMG (which means they've had generalized disease signs and/or symptoms for less than 1 year) respond to treatment with efgartigimod PH20 SC. The study consists of a treatment period of 51 weeks. The study duration for each participant will be approximately 58 weeks.
Condition
- New Onset Generalized Myasthenia Gravis (gMG)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Is at least 18 years when signing the ICF - Has been diagnosed with gMG of MGFA class II, III, or IV - Is seropositive for AChR-Ab - Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG - Had onset of generalized MG signs and/or symptoms within 12 months before screening; candidates who also had onset of ocular MG signs and/or symptoms within 24 months before screening may be enrolled in the study - Has an MG-ADL score ≥5
Exclusion Criteria
- gMG diagnosis of MGFA class I or V - Underwent a thymectomy prior to screening, except thymectomy for treatment of nonmalignant thymoma prior to the gMG diagnosis - Prior or current use of any of any systemic corticosteroid therapy or nonsteroidal immunosuppressive therapy for the treatment of gMG
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efgartigimod PH20 SC |
Participants receiving efgartigimod PH20 SC |
|
Recruiting Locations
UMass Memorial Medical Center
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
More Details
- Status
- Recruiting
- Sponsor
- argenx