RECRUITINGOBSERVATIONAL
ADAPT Forward - Master Protocol of a Platform Study to Evaluate the Safety and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
A Master Protocol for an Exploratory, Phase 2a, Proof-of-Concept Platform Study to Evaluate the Safety, Tolerability, and Efficacy of Multiple Regimens in Participants With Myasthenia Gravis
About This Trial
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. The goal is to find the best therapeutic approach to reduce patients' side effects and improve their quality of life.
Who May Be Eligible (Plain English)
Who May Qualify:
- Is at least 18 years of age and the local legal age of consent for clinical studies
- Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
- If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
Who Should NOT Join This Trial:
- Known autoimmune conditions (where your immune system attacks your own body) or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk
- Is MGFA (Myasthenia Gravis Foundation of America) Class V
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
Inclusion Criteria:
* Is at least 18 years of age and the local legal age of consent for clinical studies
* Has been diagnosed with MG with consistent clinical features per the investigator's clinical judgment
* If receiving MG therapy, including nonsteroidal immunosuppressive drugs (NSIDs), corticosteroids, or acetylcholinesterase (AChE) inhibitors either in combination or alone, the participant should receive a stable dosage before master protocol screening
Exclusion Criteria:
* Known autoimmune disease or any medical condition other than the indication under study that would interfere with an accurate assessment of clinical symptoms of MG or puts the participant at undue risk
* Is MGFA (Myasthenia Gravis Foundation of America) Class V
Treatments Being Tested
BIOLOGICAL
Efgartigimod IV
Intravenous infusion of efgartigimod
BIOLOGICAL
Empasiprubart IV
Intravenous infusion of empasiprubart
Locations (5)
Profound Research LLC - Carlsbad
Carlsbad, California, United States
Visionary Investigators Network
Miami, Florida, United States
Erlanger Health System
Columbia, Maryland, United States
Dent Neurologic Institute - Amherst
Amherst, New York, United States
National Neuromuscular Research Institute
Austin, Texas, United States