A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
NCT06909214 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2026-03-10
Summary
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.
Conditions
- New Onset Generalized Myasthenia Gravis (gMG)
Interventions
- BIOLOGICAL
-
Efgartigimod PH20 SC
Subcutaneous injection of efgartigimod PH20 SC
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-17
- Primary Completion
- 2026-08-31
- Completion
- 2027-05-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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