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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis With a Partial Clinical Response to Efgartigimod
Trial design
Other
Prospective
Treatments tested in this trial
Efgartigimod IV
Biological/VaccineIntravenous infusion of efgartigimod
Empasiprubart IV
Biological/VaccineIntravenous infusion of empasiprubart
Placebo IV
Other interventionIntravenous infusion of placebo
Efgartigimod PH20 SC PFS
Biological/VaccineSubcutaneous administration of Efgartigimod PH20 via pre-filled syringe (PFS)
Treatment groups
Trial outcomes
Primary outcomes
To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
Secondary outcomes
To evaluate the efficacy of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes
Each ISA record will specify the correct scale and time point