A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC in Adults With Ocular Myasthenia Gravis

a study on Myasthenia Gravis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around

Description

Summary

The purpose of this study is to evaluate the efficacy and safety of efgartigimod PH20 SC given by a pre-filled syringe in adult patients with ocular myasthenia gravis. The study consists of a part A (approximately 7 weeks) and a part B (up to 2 years). In part A, half of the participants will receive efgartigimod PH20 SC and the other half will receive placebo. In part B, all participants will receive efgartigimod PH20 SC. The participants will be in the study for about up to 2 years and 12 weeks.

Official Title

A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod PH20 SC Administered by Prefilled Syringe in Adult Participants With Ocular Myasthenia Gravis

Keywords

Myasthenia Gravis, Ocular, Myasthenia Gravis, Ocular myasthenia, Efgartigimod PH20 SC

Eligibility

You can join if…

Open to people ages 18 years and up

  • Is at least 18 years of age and the local legal age of consent for clinical studies
  • Has been diagnosed with myasthenia gravis and supported by seropositivity for AChR-Ab; or abnormal neuromuscular transmission demonstrated by abnormal neurophysiology testing and history on positive edrophonium chloride testing or demonstrated improvement on MG therapy"
  • Is MGFA Class I (any ocular muscle weakness)
  • Has a screening and baseline MGII (PRO) ocular score of at least 6 with at least 2 ocular items with a score of at least 2

You CAN'T join if...

  • Other diseases that lead to eyelid drooping, peripheral muscle weakness, or diplopia
  • Known autoimmune disease or any medical condition other than indication under study that would interfere with an accurate assessment of clinical symptoms of ocular myasthenia gravis or puts the participant at undue risk

Locations

  • University of California San Francisco accepting new patients
    San Francisco 5391959 California 5332921 94143 United States
  • USC Roski Eye Institute - Los Angeles accepting new patients
    Los Angeles 5368361 California 5332921 90033 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
argenx
ID
NCT06558279
Phase
Phase 3 Myasthenia Gravis Research Study
Study Type
Interventional
Participants
Expecting 124 study participants
Last Updated