A Phase 3b, Randomized, Open-label, Parallel-Group Study to Evaluate Different Dosing Regimens of Intravenous Efgartigimod to Maximize and Maintain Clinical Benefit in Patients With Generalized Myasthenia Gravis (gMG)
- Conditions
- Generalized Muscle WeaknessMyasthenia Gravis10003816
- Registration Number
- NL-OMON54098
- Lead Sponsor
- argenx BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 2
Participants are eligible to be included in the study only if all of the
following criteria apply:
1. Capable of giving signed informed consent as described in Section 10.1.3 of
the protocol, 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 informed consent.
3. Diagnosed with gMG with confirmed documentation and supported by a physical
exam and confirmed seropositivity for AChR-Abs by the central laboratory.
During the screening or rescreening period, any historical results for AChR-Ab
can be used, as long as the results are <=1 year old.
4. Meets the clinical criteria as defined by the Myasthenia Gravis Foundation
of America (MFGA) class II, III, or IV
5. Has an MG-ADL total score >=5 at screening and the day 1 visit, with more
than 50% of the score due to nonocular symptoms.
6. Concomitant gMG treatment is permitted. Permitted concomitant gMG treatment
includes nonsteroidal immunosuppressive drugs (NSIDs), steroids, and/or (AChE)
inhibitors. If receiving corticosteroids and/or NSIDs, must be on a stable dose
for at least 1 month before screening.
7. Agrees to use contraceptive measures consistent with local regulations and
the following:
a. Male participants: (contraceptive measures provided in Section 10.4.2.2 of
the protocol, refer to Section 10.7 of the protocol for country specific
requirements)
b. WOCBP (defined in Section 10.4.1 of the protocol) must have a negative serum
pregnancy test at screening and a negative urine pregnancy test at baseline
before receiving IMP (Section 10.4.2.1. of the protocol, see Section 10.7 of
the protocol for country-specific requirements).
Participants are excluded from the study if any of the following criteria
apply:
1. Clinically significant uncontrolled active or chronic bacterial, viral, or
fungal infection at screening that is not sufficiently resolved in the
investigator's opinion.
2. A positive test for SARS-CoV-2 at screening
3. Any other known autoimmune disease that, in the opinion of the investigator,
would interfere with an accurate assessment of the clinical symptoms of gMG
and/or put the participant at undue risk.
4. 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,
provided they are adequately treated at screening: a. Basal cell or squamous
cell skin cancer b. Carcinoma in situ of the cervix c. Carcinoma in situ of the
breast d. Incidental histological finding of prostate cancer (TNM stage T1a or
T1b)
5. Clinical evidence of other significant serious diseases, a recent (<3
months) major surgery, or 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint:<br /><br>Mean of the average Myasthenia Gravis Activities of Daily Living (MG-ADL) total<br /><br>score change from baseline during the visit of week (W)1 through W21 by regimen<br /><br>arm.</p><br>
- Secondary Outcome Measures
Name Time Method