Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

Key facts

Study ID

NCT04735432

Run by

argenx

People needed

110

Starts

2021-02-05

Expected to finish

2021-12-13

Last updated by the study team

2023-02-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Bullet list of each inclusion criterium:
• Must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
• At least 18 years of age at the time of signing the informed consent form.
• Diagnosed with generalized Myasthenia Gravis (gMG) with confirmed documentation and supported by at least 1 of the following:
• History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation
• History of positive edrophonium chloride test
• Demonstrated improvement in Myasthenia Gravis (MG) signs upon treatment with oral acetylcholinesterase (AChE) inhibitors as assessed by the treating physician
• Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation of America (MGFA) class II, III, IVa, or IVb

You may not qualify if…

• Bullet list of each exclusion criterium:
• Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of Investigational Medicinal Product.
• Has any of the following medical conditions:
• Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
• Any other known autoimmune disease that, in the opinion of the investigator, would interfere with an accurate assessment of clinical symptoms of myasthenia gravis or put the participant at undue risk.
• History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for ≥3 years before the first administration of the IMP. Participants with the following cancers can be included at any time:
• adequately treated basal cell or squamous cell skin cancer
• carcinoma in situ of the cervix
• carcinoma in situ of the breast
• incidental histological findings of prostate cancer (TNM Classification of Malignant Tumors stage T1a or T1b).
• Clinical evidence of other significant serious diseases, or the participant has had a recent major surgery, or who have any other condition that, in the opinion of the investigator, could confound the results of the study or put the participant at undue risk.

Where it is running

• Investigator site 2 - US0010032 — Carlsbad, California, United States
• Investigator Site 41 - US0010004 — Orange, California, United States
• Investigator site 2 - US0010108 — Boca Raton, Florida, United States
• Investigator site 1 - US0010110 — Port Charlotte, Florida, United States
• Investigator Site 27 - US0010006 — Tampa, Florida, United States
• Investigator Site 47 - US0010113 — Augusta, Georgia, United States
• Investigator Site 42 - US0010015 — Kansas City, Kansas, United States
• Investigator Site 11 - US0010111 — Amherst, New York, United States
• Investigator Site 40 - US0010003 — Chapel Hill, North Carolina, United States
• Investigator Site 38 - US0010077 — Durham, North Carolina, United States
• Investigator Site 43 - 0010019 — Cleveland, Ohio, United States
• Investigator site 4 - US0010008 — Cordova, Tennessee, United States
• Investigator Site 28 - US0010066 — Austin, Texas, United States
• Investigator Site 46 - US0010009 — Texas City, Texas, United States
• Investigator site 5 - BE0320007 — Ghent, East-Flanders, Belgium
• Investigator site 13 - GE9950002 — Tbilisi, Georgia
• Investigator site 12 - GE9950001 — Tbilisi, Georgia
• Investigator site 14 - GE9950003 — Tbilisi, Georgia
• Investigator Site 44 - GE9950004 — Tbilisi, Georgia
• Investigator Site 45 - GE9950016 — Tbilisi, Georgia
• Investigator Site 30 - DE490006 — Berlin, Germany
• Investigator Site 29 - DE490009 — Münster, Germany
• Investigator site 15 - HU0360013 — Budapest, Hungary
• Investigator Site 16 - HU0360020 — Debrecen, Hungary
• Investigator Site 17 - IT0390003 — Milan, Italy

Full record on ClinicalTrials.gov

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