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A Phase 3 study to evaluate the Efficacy and Safety of Efgartigimod IV in Patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis
EU CTIS ID: 2024-511796-15-00
What this study is testing
To determine the efficacy of efgartigimod IV compared to placebo in participants with AChR-Ab seronegative gMG in part A
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1.Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- 2.The participant is capable of providing signed informed and complying with protocol requirements
- 3.The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the investigational medicinal product (IMP).
- 4.The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following: a) History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive b) Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment.
- 5.The participant is receiving a stable dose of MG therapy before screening that includes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone.
You likely can't join if
- 1.Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk
- 10. Received a thymectomy less than 3 months before screening or thymectomy is planned during the study
- 11.Use of some medications before screening (more information is captured in the protocol)
- 2.History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years before first investigational medicinal product (IMP) administration. Adequately treated participants with the following cancers can be included at any time: 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.
- 3.Clinically significant active infection that is not sufficiently resolved before baseline in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV.
- 4.Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and received at least 1 dose of investigational medicinal product (IMP)
See the full eligibility criteria
Who can join
- 1.Is at least 18 years of age and the local legal age of consent for clinical studies when signing the ICF.
- 2.The participant is capable of providing signed informed and complying with protocol requirements
- 3.The participant agrees to use contraceptive measures consistent with local regulations and the women of child-bearing potential (WOCBP) must have a negative serum pregnancy test result at screening and a negative urine pregnancy test result at baseline before receiving the investigational medicinal product (IMP).
- 4.The participant has no known weakness in infancy and later develop fatigable weakness after aged 16 years and diagnosed with acquired gMG of both of the following: a) History of abnormal neuromuscular transmission demonstrated by single fiber electromyography or repetitive nerve stimulation (RNS) or is anti-muscle-specific kinase antibodies (MuSK-Ab) seropositive b) Either a history of positive edrophonium chloride test OR a demonstrated improvement in MG signs with treatments such as oral acetylcholinesterase (AChE) inhibitors, plasma exchange (PLEX), immunoabsorption, or intravenous immunoglobulin (IVIg)/ subcutaneous immunoglobulin (SCIg) treatment.
- 5.The participant is receiving a stable dose of MG therapy before screening that includes acetylcholinesterase (AChE) inhibitors, steroids, or nonsteroidal immunosuppressive therapies (NSISTs) in combination or alone.
What rules you out
- 1.Known autoimmune disease or any medical condition that would interfere with an accurate assessment of clinical symptoms of gMG or puts the participant at undue risk
- 10. Received a thymectomy less than 3 months before screening or thymectomy is planned during the study
- 11.Use of some medications before screening (more information is captured in the protocol)
- 2.History of malignancy unless considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years before first investigational medicinal product (IMP) administration. Adequately treated participants with the following cancers can be included at any time: 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.
- 3.Clinically significant active infection that is not sufficiently resolved before baseline in the investigator's opinion or positive serum test at screening for active infection with any of the following: Hepatitis B virus (HBV), Hepatitis C virus (HCV), HIV.
- 4.Current participation in another interventional clinical study or previous participation in an efgartigimod clinical study and received at least 1 dose of investigational medicinal product (IMP)
- 5.Known hypersensitivity to investigational medicinal product (IMP) or any of its excipients
- 6.History of or current alcohol, drug, or medication abuse as assessed by the investigator
- 7.Pregnant or lactating state or intention to become pregnant during the study
- 8. Live or live-attenuated vaccine received less than 4 weeks before screening
- 9.Worsening muscle weakness secondary to concurrent infections or medications
The study team makes the final eligibility decision.
Where it's taking place
- Georgia
- Saudi Arabia
- United States
- United Kingdom
- Serbia
- Korea, Republic of
- Canada
- China
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Georgia; Saudi Arabia; United States; United Kingdom; Serbia; Korea, Republic of and 2 more location(s). 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 EU CTIS; the study team decides eligibility.