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).

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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
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article

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)

James F. Howard, Carolina Barnett‐Tapia, Sophie Steeland, Sui H. Wong et al.
Neurology
Myasthenia Gravis and Thymoma
article

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)

James F. Howard, Carolina Barnett‐Tapia, Sophie Steeland, Sui H. Wong, Rosa María Rodríguez Jiménez, Fien Gistelinck, Jeff Guptill, Fien Verhamme
article en

Abstract

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).

NeurologyVol. 104(7_Supplement_1)
University of Toronto (CA), Moorfields Eye Hospital (GB), Argenx (Belgium) (BE), University College London (GB)
Good health and well-being
Openalex Percentile: Top 88%
Myasthenia Gravis and Thymoma
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