Efgartigimod for New-onset Generalized Myasthenia Gravis

A Study to Evaluate the Clinical Outcomes of Efgartigimod PH20 SC in Adults With New-onset Generalized Myasthenia Gravis (gMG)

Recruiting Phase 4 Interventional Study
New Onset Generalized Myasthenia Gravis (gMG)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
30 (estimated)
Sponsor
argenx · Industry
Who this trial is looking for

This trial is looking for adults who have recently been diagnosed with generalized myasthenia gravis (gMG). Participants will receive treatment with efgartigimod PH20 SC over a period of about 51 weeks.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with gMG of MGFA class II, III, or IV.
  • I have a positive AChR antibody test.
  • I have not been treated for gMG before or have used AChEI.
  • I had the first signs of gMG less than 1 year ago.
  • I have an MG-ADL score of 5 or more.

You may not be able to join if

  • I have gMG diagnosed as MGFA class I or V.
  • I had a thymectomy before screening, except for a nonmalignant thymoma.
  • I have used any systemic corticosteroid therapy for gMG.
  • I have used any nonsteroidal immunosuppressive therapy for gMG.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Is at least 18 years when signing the ICF * Has been diagnosed with gMG of MGFA class II, III, or IV * Is seropositive for AChR-Ab * Is treatment-naive for gMG or has been administered AChEI for the treatment of gMG * Had onset of generalized MG signs and/or symptoms within 12…
Contacts

Sabine Coppieters, MD

857-350-4834

clinicaltrials@argenx.com

CONTACT