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New treatment option for Efgartigimod
Official title Seronegative Myasthenia Gravis - Efgartigimod IV
ClinicalTrials.gov ID: NCT06587867
What this study is testing
What is efgartigimod?
efgartigimod is an investigational medicine, given as an once-weekly, being studied as a potential treatment for efgartigimod.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is to study the efficacy, safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis. This is an open label study.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Evidence of signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the trial. people...
- Male or female people ≥ 18 years old.
- Diagnosis of SN MG defined as: (a) clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition, (b)...
- MGFA Clinical Classification Class II, III, or IV at the time of screening and baseline.
- Moderate to severe myasthenia gravis as defined by a generalized myasthenia gravis impairment index score \> 11 or MG-ADL score of at least 5 (with...
You likely can't join if
- Patients who discontinued early from trials of efgartigimod for pregnancy or rescue reasons or an SAE that was likely to result in a life-threatening...
- Pregnant and lactating women, and those intending to become pregnant during the trial or within 3 months after the last dosing. Women of childbearing...
- Male patients who are sexually active and do not intend to use effective methods of contraception (as mentioned above) during the trial or within 3...
- Patients with known hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) seropositivity.
- Patients with known autoimmune disease other than MG (e.g., rheumatoid arthritis) which in the investigator opinion would interfere with an accurate...
- Patients with clinical evidence of other significant disease or patients who underwent a recent major surgery, which could confound the results of...
See the full eligibility criteria
Who can join
- Evidence of signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the trial. people must be willing and able to comply with the protocol, complete study...
- Male or female people ≥ 18 years old.
- Diagnosis of SN MG defined as: (a) clinical syndrome consistent with a diagnosis of MG, and not otherwise explained by another condition, (b) abnormal neuromuscular transmission test results demonstrated by single-fiber...
- MGFA Clinical Classification Class II, III, or IV at the time of screening and baseline.
- Moderate to severe myasthenia gravis as defined by a generalized myasthenia gravis impairment index score \> 11 or MG-ADL score of at least 5 (with \>50% of the score due to non-ocular symptoms) and a PASS response of...
- Stable or worsening MG as defined by MGII remaining stable or increasing in the 4 week run-in interval.
- Patients are required to be on a stable dose of their MG treatment (Standard of care-SoC) for at least one month prior to screening. The SoC is limited to AChE inhibitors, steroids and NSISTs (e.g., azathioprine...
- Patients who discontinued early from previous trials of efgartigimod for reasons other than pregnancy, rescue therapy or a SAE can be included.
- Females of childbearing potential who are sexually active with a non-sterilized male partner must be willing to use at least one highly effective contraception method from the time of screening and for 3 months after...
- Non-sterilized males who are sexually active with a female partner of childbearing potential must be willing to use a condom for the duration of the study and for 3 months after the last dose of efgartigimod. Because...
- Vital signs, electrocardiogram (ECG), and laboratory parameters within the normal ranges at screening, or, if outside normal ranges, deemed not clinically significant by the Investigator.
- Patient has documented IgG \>6 g/L within one month of screening
- Vaccinated for COVID-19 at least 2 weeks prior to screening visit.
What rules you out
- Patients who discontinued early from trials of efgartigimod for pregnancy or rescue reasons or an SAE that was likely to result in a life-threatening situation or pose a serious safety risk.
- Pregnant and lactating women, and those intending to become pregnant during the trial or within 3 months after the last dosing. Women of childbearing potential should have a negative urine pregnancy test at screening...
- Male patients who are sexually active and do not intend to use effective methods of contraception (as mentioned above) during the trial or within 3 months after the last dosing or male patients who plan to donate sperm...
- Patients with known hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) seropositivity.
- Patients with known autoimmune disease other than MG (e.g., rheumatoid arthritis) which in the investigator opinion would interfere with an accurate assessment of clinical symptoms.
- Patients with clinical evidence of other significant disease or patients who underwent a recent major surgery, which could confound the results of the trial or put the patient at undue risk.
- Patients with renal/hepatic function impairment as defined by (Cr\>1.5 x elevated) and/or (transaminases \> 2.5 x elevation) at screening.
- Patients with known medical history of hypersensitivity to any of the ingredients of efgartigimod.
- Patients who have received rituximab or eculizumab in the 6 months before screening.
- Patients who have undergone thymectomy within 3 months of screening.
- Patients who had intravenous immunoglobulin or plasma exchange within 4 weeks of screening.
- Patient who has clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection at screening
- Patient has received a live or a live-attenuated vaccination during the month before screening
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.