Design of a Phase 3 Randomized, Double-blinded, Placebo-controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia Gravis (P1-11.003)
To report the design of a Phase 3, randomized, double-blind, placebo-controlled study evaluating the efficacy and safety of subcutaneous (SC) efgartigimod PH20 (coformulated with recombinant human hyaluronidase PH20), an immunoglobulin G (IgG)1 antibody Fc-fragment that selectively reduces IgG levels by blocking neonatal Fc receptor (FcRn)-mediated IgG recycling, in ocular myasthenia gravis (oMG).
Authors
- James F. Howard (ORCID: https://orcid.org/0000-0002-7136-8617)
- Carolina Barnett‐Tapia
- Sophie Steeland
- Sui H. Wong (ORCID: https://orcid.org/0000-0003-2554-6731)
- Rosa María Rodríguez Jiménez (ORCID: https://orcid.org/0000-0003-0467-2886)
- Fien Gistelinck
- Jeff Guptill
- Fien Verhamme
Institutions
- University of Toronto (CA)
- Moorfields Eye Hospital (GB)
- Argenx (Belgium) (BE)
- University College London (GB)
Publication Details
- Journal
- Neurology
- Published
- 2025-04-07
- DOI
- https://doi.org/10.1212/wnl.0000000000210433
- Primary Topic
- Myasthenia Gravis and Thymoma
- Type
- article
- Field-Weighted Citation Impact
- 0.00