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New treatment option for AChR-Ab Seropositive Generalized Myasthenia Gravis
Official title ADAPT Forward 1 - ISA1 - a Study to Evaluate Empasiprubart IV as add-on Therapy to Efgartigimod IV in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
ClinicalTrials.gov ID: NCT07284420
What this study is testing
What is Efgartigimod IV?
Efgartigimod IV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for achr-ab seropositive generalized myasthenia gravis.
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 study is part of the ADAPT Forward platform study (NCT07294170). ADAPT Forward is a platform study with the aim to look at how safe different drugs are and how well they work for people with myasthenia gravis.
- Phase 2: a mid-size study of how well it works
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
- Is seropositive for anti-acetylcholine receptor antibodies (AChR-Ab)
- Has confirmed diagnosis of gMG and is Myasthenia Gravis Foundation of America (MGFA) Class II, III, IVa, or IVb
- Has documented immunization against encapsulated bacterial pathogens (Neisseria meningitidis and Streptococcus pneumoniae) within 5 years of ISA...
You likely can't join if
- Clinical diagnosis of systemic lupus erythematosus (SLE)
- Any known complement deficiency
- Current administration of a complement inhibitor or received zilucoplan or eculizumab \<2 months or ravulizumab \<6 months before the first study...
- Patients proven to be refractory to efgartigimod (ie, not achieving a clinically meaningful improvement in total Myasthenia Gravis Activities of...
The study team makes the final eligibility decision.
Where it's taking place
- Carlsbad, California, United States
- Miami, Florida, United States
- Tampa, Florida, United States
- Detroit, Michigan, United States
- Amherst, New York, United States
- Durham, North Carolina, United States
- Columbus, Ohio, United States
- Chattanooga, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Leuven, Belgium
- Bergamo, Lombardy, Italy
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Katowice, Silesian Voivodeship, Poland
- Málaga, Malaga, Spain
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 Carlsbad, California, United States; Miami, Florida, United States; Tampa, Florida, United States; Detroit, Michigan, United States; Amherst, New York, United States; Durham, North Carolina, United States and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.