Evaluating the Long-term Safety and Tolerability of Efgartigimod PH20 SC Administered Subcutaneously in Patients With Generalized Myasthenia Gravis
- Conditions
- Generalized Myasthenia GravisMedDRA version: 21.1Level: PTClassification code 10028417Term: Myasthenia gravisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2020-004086-38-HU
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 201
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, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
2. Previously participated in antecedent studies ARGX-113-2001 or ARGX-113-1705 and are eligible for rollover
3. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and:
a. Male participants:
- Male participants are not allowed to donate sperm from signing the ICF until the last end of the study.
b. Female participants:
- Women of Child bearing potential (WOCBP) must have a negative urine pregnancy test at baseline before IMP can be administered.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 121
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
Participants are excluded from the study if any of the following criteria apply:
1. 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 rollover 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 rollover into ARGX-113-2002.
2. Are pregnant or lactating, or intend to become pregnant during the study or within 90 days after the last dose of IMP
3. Have any of the following medical conditions:
a. Clinically significant uncontrolled chronic bacterial, viral, or fungal infection at screening
b. 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
c. History of malignancy unless deemed cured by adequate treatment with no evidence of reoccurrence for =3 years before the first administration of 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of efgartigimod PH20 SC in participants with Generalized Myasthenia Gravis (gMG);Secondary Objective: • To evaluate the impact of efgartigimod PH20 SC on disease severity<br>• To evaluate the effect of efgartigimod PH20 SC on Pharmacodynamic (PD)<br>• To evaluate the PK of efgartigimod PH20 SC<br>• To evaluate the immunogenicity of efgartigimod PH20 SC<br>;Primary end point(s): • Incidence of Serious Adverse Events (SAEs), and AEs of special interest (AESIs);Timepoint(s) of evaluation of this end point: The primary end point is timeframe 'up to 2 years'.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Percentage reduction in levels of total immunoglobulin G (IgG) from baseline and cycle baseline over time by cycle<br>• Percentage reduction of anti-acetylcholine receptor antibodies (AChR-Ab) from baseline and cycle baseline over time by cycle in AChR-Ab seropositive participants<br>• Efgartigimod serum concentrations<br>• Incidence and prevalence of anti-drug antibodies (ADAs) to efgartigimod over time<br><br>;Timepoint(s) of evaluation of this end point: All secondary end points are timeframe 'up to 2 years'.