Status:
COMPLETED
Evaluating the Long-Term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously 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 evaluate the long-term safety and tolerability of efgartigimod PH20 SC 1000 mg, and the clinical efficacy, PD, pharmacokinetics (PK), immunogenicity, impact on the qual...
Eligibility Criteria
Inclusion
- 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 and:
- Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before investigational medicinal product (IMP) can be administered.
Exclusion
- 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.
- a. 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 roll-over
- 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)
- 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
- Received a live-attenuated vaccine within 28 days prior to study entry or plan to receive a live-attenuated vaccine during the study
- A known hypersensitivity reaction to efgartigimod, rHuPH20, or any of its excipients
Key Trial Info
Start Date :
April 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
184 Patients enrolled
Trial Details
Trial ID
NCT04818671
Start Date
April 26 2021
End Date
December 31 2024
Last Update
January 24 2025
Active Locations (47)
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1
Investigator site 6 - US0010032
Carlsbad, California, United States, 92011
2
Investigator Site 47 - US0010021
Palo Alto, California, United States, 94304
3
Investigator Site 45 - US0010108
Boca Raton, Florida, United States, 33428
4
Investigator site 4 - US0010110
Port Charlotte, Florida, United States, 33952