Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis (ADAPTsc)
Generalized Myasthenia Gravis
About this trial
This is an interventional treatment trial for Generalized Myasthenia Gravis
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
Sites / Locations
- Investigator site 2 - US0010032
- Investigator Site 41 - US0010004
- Investigator site 2 - US0010108
- Investigator site 1 - US0010110
- Investigator Site 27 - US0010006
- Investigator Site 47 - US0010113
- Investigator Site 42 - US0010015
- Investigator Site 11 - US0010111
- Investigator Site 40 - US0010003
- Investigator Site 38 - US0010077
- Investigator Site 43 - 0010019
- Investigator site 4 - US0010008
- Investigator Site 28 - US0010066
- Investigator Site 46 - US0010009
- Investigator site 5 - BE0320007
- Investigator site 13 - GE9950002
- Investigator site 12 - GE9950001
- Investigator site 14 - GE9950003
- Investigator Site 44 - GE9950004
- Investigator Site 45 - GE9950016
- Investigator Site 30 - DE490006
- Investigator Site 29 - DE490009
- Investigator site 15 - HU0360013
- Investigator Site 16 - HU0360020
- Investigator Site 17 - IT0390003
- Investigator Site 39 - IT0390008
- Investigator Site 31 - JP0810055
- Investigator Site 18 - JP0810002
- Investigator site 6 - JPN0810004
- Investigator Site 33 - JP0810058
- Investigator Site 19 - JP0810007
- Investigator Site 34 - JP0810005
- Investigator Site 32 - JP0810059
- Investigator Site 20 - JP0810009
- Investigator Site 7 - NL0310001
- Investigator Site 21 - PL0480001
- Investigator Site 8 - PL0480007
- Investigator Site 9 - PL0480024
- Investigator Site 22 - PL0480005
- Investigator Site 23 - PL0480018
- Investigator Site 24 - PL0480022
- Investigator Site 35 - RU0070002
- Investigator Site 36 - RU0070014
- Investigator Site 37 - ES0340021
- Investigator Site 26 - ES0340038
- Investigator Site 25 - ES0340002
- Investigator Site 10 - ES0340039
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
efgartigimod PH20 SC
efgartigimod
Patients receiving efgartigimod PH20 subcutaneous (SC) treatment
Patients receiving efgartigimod intravenous (IV) treatment