Status:
COMPLETED
Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis
Lead Sponsor:
argenx
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant ...
Detailed Description
Main objective of the trial: To demonstrate that the pharmacodynamic (PD) effect of injections of 1000 mg efgartigimod PH20 SC (efgartigimod co-formulated with recombinant humanhyaluronidase PH20 for ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 13 2021
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT04735432
Start Date
February 5 2021
End Date
December 13 2021
Last Update
February 28 2023
Active Locations (47)
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1
Investigator site 2 - US0010032
Carlsbad, California, United States, 92011
2
Investigator Site 41 - US0010004
Orange, California, United States, 92868
3
Investigator site 2 - US0010108
Boca Raton, Florida, United States, 33428
4
Investigator site 1 - US0010110
Port Charlotte, Florida, United States, 33952