Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis

  • End date
    Apr 30, 2023
  • participants needed
  • sponsor
Updated on 4 September 2021
immune globulin
generalized myasthenia gravis
immunoglobulin g (igg)


The purpose of this study is to evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the quality of life (QoL) of the participants, treatment satisfaction, and administration method preference, and the feasibility of self- and caregiver-supported administration of the SC injection.

Study details include: Study duration: 2 years

Treatment duration: 3-week treatment periods, repeated as needed with at least 28 days in between treatment periods

Health measurements: total levels of immunoglobulin G (IgG), Acetylcholine receptor binding autoantibodies (AChR-Ab) levels, Myasthenia Gravis Activities of Daly Living (MG-ADL).

Condition Myasthenia Gravis, generalized myasthenia gravis
Treatment efgartigimod PH20 SC
Clinical Study IdentifierNCT04818671
Last Modified on4 September 2021


Yes No Not Sure

Inclusion Criteria

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
Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for roll over
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Male participants
Male participants are not allowed to donate sperm from signing the informed consent (ICF) until the end of study
Female participants
Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered

Exclusion Criteria

The participant was discontinued early from studies ARGX-113-2001 or ARGX-113-1705, unless the reason for discontinuation from study ARGX-113-1705 was to roll over into study ARGX-113-2002
Participants who, in the investigator's judgment, are not benefiting from efgartigimod IV in study ARGX-113-1705 Part B are not eligible for roll over into ARGX-113-2002
Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of investigational medicinal product (IMP)
Has any of the following medical conditions
Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at screening
Any other known autoimmune disease that, in the opinion of the investigator, would interfere with 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 investigational medicinal product (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) 4. 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 4. Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study 5. A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients
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