A Phase 3, Randomized, Open-Label, Parallel-Group Study to Compare the Pharmacodynamics, Pharmacokinetics, Efficacy, Safety, Tolerability, and Immunogenicity of Multiple Subcutaneous Injections of Efgartigimod PH20 SC with Multiple Intravenous Infusions of Efgartigimod in Patients with Generalized Myasthenia Gravis (ADAPT) - ADAPT SC

argenx BV0 sites2 target enrollmentStarted: TBDLast updated: April 9, 2024

Conditions

Trial Snapshot

Phase: Phase 3
Status: Completed
Sponsor: argenx BV
Enrollment: 2

Study Overview Eligibility Criteria Investigators Records & Identifiers Similar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type: Interventional

Eligibility Criteria

Ages: 18 to 99 (—)

Inclusion Criteria

•Participants are eligible to be included in the study only if all of the
•following criteria apply:
•1. Must be capable of giving signed informed consent as described in Section
•10.1, which includes compliance with the requirements and restrictions listed
•in the informed consent form (ICF) and in this protocol.
•2. At least 18 years of age at the time of signing the ICF.
•3. Diagnosed with gMG with confirmed documentation and supported by at least 1
•of the following:
•a. History of abnormal neuromuscular transmission demonstrated by single fiber
•electromyography or repetitive nerve stimulation
•b. History of positive edrophonium chloride test
•c. Demonstrated improvement in MG signs upon treatment with oral
•acetylcholinesterase (AChE) inhibitors as assessed by the treating physician
•4. Meeting the clinical criteria as defined by the Myasthenia Gravis Foundation
•of America (MGFA) class II, III, IVa, or IVb
•5. Abdominal skin tissue allows for absorption and assessment of local safety
•of the planned SC injection, as determined by the investigator.
•6. An MG-ADL total score of *5 points, with more than 50% of the score due to
•nonocular symptoms at screening and baseline.
•7. Receiving a stable dose of other gMG treatment (concomitant gMG treatment)
•prior to screening. For patients receiving nonsteroidal immunosuppressants
•(NSIDs), steroids, and/or AChE inhibitors as concomitant medications, the
•following dose conditions apply:
•a. NSIDs (eg, azathioprine, methotrexate, cyclosporine, tacrolimus,
•mycophenolate mofetil, and cyclophosphamide): treatment initiated at least 6
•months prior to screening and no changes to dose in the 3 months before
•b. Steroids: treatment initiated at least 3 months prior to screening and no
•dose changes in the month before screening
•c. AChE inhibitors: stable dose with no dose escalation during the 2 weeks
•before screening. AChE inhibitors must be withheld for at least 12 hours before
•the QMG assessment, to be consistent with the revised manual for the QMG test,
•as recommended by the MFGA.
•8. Contraceptive use should be consistent with local regulations regarding the
•methods of contraception for those participating in clinical studies and:
•a. Male participants are eligible to participate if they agree to the following
•during the intervention period and for at least 90 days after the last study
•dose of the IMP:
•* Refrain from donating sperm
•Plus either
•* Be abstinent from heterosexual intercourse as their preferred and usual
•lifestyle (abstinent on a long term and persistent basis) and agree to remain
•* Must agree to use a male condom with a female partner using an additionally
•highly effective contraceptive method with a failure rate of <1% per year as
•described in Section 10.5. when having sexual intercourse with a woman of
•childbearing potential who is not currently pregnant
•* Be a sterilized man who has had a documented absence of sperm post-procedure
•b. Female participants are eligible to participate if they are not pregnant or
•breastfeeding, and they are 1 of the following:
•* Women of non-childbearing potential (WONCBP), as defined in Section 10.5.1.
•* Women of childbearing potential (WOCBP) as defined in Section 10.5.1 and is
+1 more not shown

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•1. Are pregnant or lactating, or intend to become pregnant during the study or
•within 90 days after the last dose of IMP.
•2. Has any of the following medical conditions:
•a. Clinically significant uncontrolled active or chronic bacterial, viral, or
•fungal infection at screening
•b. 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
•c. 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).
•d. 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.
•3. Worsening muscle weakness secondary to concurrent infections or medications
•(aminoglycosides, beta-blockers, etc.)
•4. A documented lack of clinical response to plasma exchange (PLEX)
•5. Received a live-attenuated vaccine fewer than 28 days before screening.
•Receiving an inactivated subunit, polysaccharide, or conjugate vaccine any time
•before screening is not exclusionary.
•6. Received a thymectomy <3 months prior to screening or one is planned to
•be performed during the study period.
•7. The following results from these diagnostic assessments will be considered
•exclusionary:
•a. Positive serum test at screening for an active viral infection with any of
•the following conditions:
•* Hepatitis B virus (HBV) that is indicative of an acute or chronic infection
•(https://www.cdc.gov/hepatitis/HBV/PDFs/SerologicChartv8.pdf, see Section 10.8)
•* Hepatitis C virus (HCV) based on HCV antibody assay
•* Human immunodeficiency virus (HIV) based on a CD4 count of <200 cells/mm3
•or test results that are associated with an acquired immunodeficiency syndrome
•(AIDS)-defining condition, such as: Cytomegalovirus retinitis with loss of
•vision, Pneumocystis jiroveci pneumonia, chronic intestinal cryptosporidiosis,
•HIV-related encephalopathy, Mycobacterium tuberculosis (pulmonary or
•extrapulmonary), or invasive cervical cancer
•b. Positive nasopharyngeal swab test for SARS-CoV-2
•8. Using the following prior or concomitant therapies:
•a. Use of an investigational product within 3 months or 5 half-lives (whichever
•is longer) before the first dose of IMP
•b. Use of any monoclonal antibody within 6 months before the first dose of the
•c. Use of Ig administered intravenously (IVIg), SC (SCIg), or intramuscularly
•within 4 weeks of screening
•d. Use of PLEX within 4 weeks of screening
+4 more not shown

Investigators

Sponsor

argenx BV

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