A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)
Part of paid clinical trials in La Jolla, California.
- Sponsor
- argenx
- Study ID
- NCT06909214
- Phase
- PHASE4
- Status
- Recruiting
Conditions
- New Onset Generalized Myasthenia Gravis (gMG)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Efgartigimod PH20 SC — BIOLOGICALSubcutaneous injection of efgartigimod PH20 SC
Study Details
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.
Key Dates
- Start date
- Apr 17, 2025
- Status verified
- Mar 2026
- Primary completion
- Aug 31, 2026
- Completion
- May 31, 2027
Study Design
- Enrollment
- 30 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Efgartigimod PH20 SCParticipants receiving efgartigimod PH20 SC
Primary Outcome Measure
Proportion of participants who achieve MSE of MG at any time within the first 16 weeks of treatment with efgartigimod PH20 SC [ Time Frame: up to 16 weeks ]
Central Contacts
- Sabine Coppieters, MD857-350-4834
Locations (18)
Find similar trials in La Jolla, CA
By research site
University of California, San Diego - Altman Clinical and Translational Research Institute (ACTRI)· La Jolla, CASamir Macwan, M.D., Inc. (S corporation)· Rancho Mirage, CAEZR Research· Boca Raton, FLUniversity of Florida Jacksonville· Jacksonville, FLVisionary Investigators Network· Miami, FLUniversity of California Irvine· Orange, FL