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MP Public Title:ADAPT Forward - Master protocol of a platform study to evaluate the safety and efficacy of multiple regimens in participants with Myasthenia Gravis ISA 2 Public Title: ADAPT Forward 2 – ISA2 – a study to evaluate the safety, tolerability and efficacy of Empasiprubart IV Monotherapy in Participants With AChR-Ab Seropositive Generalized Myasthenia Gravis
EU CTIS ID: 2025-522939-33-00
What this study is testing
MP - To determine the safety and tolerability of multiple regimens (monotherapy or add-on therapy to backbone therapy) in MG subtypes. ISA 2 - To evaluate the safety and tolerability of empasiprubart IV as a monotherapy
- Therapeutic exploratory (Phase II)
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
- MP Main inclusion criteria: o Is at least 18 years of age and the local legal age of consent for clinical studies o Has been diagnosed with MG consistent with MG's clinical features and with symptom severity appropriate for currently enrolling ISAs, per the investigator’s clinical judgment o 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
- ISA 2- - 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 before ISA screening or will complete immunization at least 14 days before the first IMP administration
You likely can't join if
- MP Main exclusion criteria: o 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. o Is MGFA (Myasthenia Gravis Foundation of America) Class V
- ISA 2- - Clinical diagnosis of systemic lupus erythematosus (SLE) - Is receiving concurrent complement inhibitors (eg, eculizumab, zilucoplan, ravulizumab, or others). Participants who received zilucoplan or eculizumab >2 months or ravulizumab >6 months before baseline are allowed to participate. - Has received an FcRn antagonist, including efgartigimod, within 4 weeks before baseline -Had prior empasiprubart exposure
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United States
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United States. 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.